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Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring: Recommendations for a Public Health Approach [Internet]. Geneva: World Health Organization; 2021 Jul.

Cover of Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring: Recommendations for a Public Health Approach

Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring: Recommendations for a Public Health Approach [Internet].

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7SERVICE DELIVERY

7.1. Introduction

WHO’s public health approach to delivering ART has enabled access to treatment and care for people living with HIV to be scaled up, with an estimated 67% of people living with HIV receiving ART in 2020 – 25.4 million of 38 million people living with HIV, up from 7.8 million in 2010 (1).

To reinforce the delivery of ART at scale, WHO promotes a public health approach to ART, using simplified and standardized ART that supports the decentralization of care, task sharing and community delivery and more efficient procurement and supply management (2). The 2016 WHO consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection (3) included a chapter that provides several recommendations for delivering HIV services across the cascade of care from HIV testing to long-term viral suppression.

Notwithstanding the progress made in increasing access to treatment, challenges remain. Studies over the past decade have found that many people living with HIV disengage from care after starting treatment. In sub-Saharan Africa, about one third of adults disengaged from care within five years of starting treatment (4). Long-term retention in care is an important challenge across geographical settings and age groups (58), and those who have disengaged and stopped taking ART are at increased risk of transmitting HIV to other people, progressing to AIDS and dying.

This chapter provides updated recommendations and good practice statements in the following areas:

  • linkage from HIV testing to enrolment in care;
  • differentiated service delivery;
  • people-centred care;
  • initiating ART outside the health facility;
  • rapid initiation of ART, including same-day start;
  • adherence:

    monitoring adherence to ART in routine programme and care settings;

  • retention in care;
  • tracing and re-engagement in care;
  • frequency of clinical visits and ART pick-up;
  • task sharing:

    task sharing for initiation and maintenance of ART;

    task sharing of specimen collection and point-of-care testing;

  • decentralization;
  • integrating and linking services:

    delivering ART in maternal and child health care settings;

    delivering ART in TB treatment settings and TB treatment in HIV care settings;

    integrating sexual and reproductive health services, including contraception, within HIV services;

    integrating diabetes and hypertension care with HIV care;

    ART in settings providing opioid substitution therapy;

    diagnostic integration;

  • care transition;
  • delivering high-quality HIV services to adolescents; and
  • psychosocial interventions for adolescents and young adults living with HIV

Special considerations for the continuity and quality of service delivery:

  • quality service delivery;
  • ensuring a stable supply chain of ARV drugs; and
  • laboratory and diagnostic services and connectivity.

Applicability of service delivery recommendations

In contrast to most clinical interventions, service delivery interventions are generally highly context specific in terms of both relative effectiveness and relative importance in a given context. Consistent with the burden of disease, much of the evidence supporting the recommendations in this chapter comes from studies undertaken in sub-Saharan Africa. Recognizing the importance of streamlined, standardized approaches to scaling up HIV services in settings with limited resources, the public health approach emphasizes strategies such as task sharing, decentralization and integrating HIV services with other public health programmes and patient and community empowerment. High-income countries with more resources and fewer HIV cases favour a more individualized approach to HIV care, although the overarching framework of the public health approach provides the setting within which this more personalized service delivery can occur.

Importantly, several populations are subject to structural barriers, including stigma, discrimination, criminalization and violence. This is especially important for women, young girls and adolescents and key populations, who are subject to these barriers across the HIV care cascade. Although service delivery is primarily aimed at developing programmatic guidance to help implement all the WHO recommendations, the basic principles for developing these WHO recommendations align with the concept of people-centred care, the public health approach and a rights-based approach.

The forthcoming WHO consolidated guidelines on HIV services for key populations describe essential strategies for an enabling environment, which include developing supportive legislation, policy, including working towards decriminalizing behaviour, financial commitment, addressing stigma and discrimination, empowering communities and addressing violence against key populations. WHO also supports a strong emphasis on workforce training against stigma, discrimination and strategies to support those that are subject to violence, to ensure that all populations benefit from accessing better and safer health-care services.

7.2. Linkage from HIV testing to enrolment in care

Recommendation (2016)

Following an HIV diagnosis, a package of support interventions should be offered to ensure timely linkage to care for all people living with HIV(strong recommendation, moderate-certainty evidence).

The following interventions have demonstrated benefit in improving linkage to care following an HIV diagnosis:

  • streamlined interventions to reduce time between diagnosis and engagement in care, including (1) enhanced linkage with case management; (2) support for HIV disclosure; (3) tracing; (4) training staff to provide multiple services, and (5) streamlined services (moderate-certainty evidence);
  • Peer supporta and navigation approaches for linkage (moderate-certainty evidence); and
  • quality improvement approaches using data to improve linkage (low-certainty evidence).

Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infections: recommendations for a public health approach – second edition (3)

a

Includes peer counselling.

Good practice statements (2019)

ART initiation should follow the overarching principles of providing people-centred care. People-centred care should be focused and organized around the health needs, preferences and expectations of people and communities, upholding individual dignity and respect, especially for vulnerable populations. It should promote the engagement and support of people and families to play an active role in their own care through informed decision-making.

All people newly diagnosed with HIV should be retested to verify their HIV status before starting ART, using the same testing strategy and algorithm as the initial test. To minimize the risk of misdiagnosis, this approach should be maintained in settings in which rapid ART initiation is being implemented.

The introduction of the “treat all” recommendation (ART for all people living with HIV regardless of CD4 cell count) supports the rapid initiation of ART, including the offer of same-day initiation where there is no clinical contraindication.

People with no contraindication to rapid ART initiation should be fully informed of the benefits of ART and offered rapid ART initiation, including the option of same-day initiation. Rapid start of ART is especially important for people with very low CD4 cell counts, among whom the risk of death is high. People should not be coerced to start immediately and should be supported in making an informed choice regarding when to start ART.

Source: Consolidated guidelines on HIV testing services, 2019 (9)

Background

Linkage to prevention, treatment and care following HIV testing is a major global challenge. Improvements in treatment availability have enabled higher rates of linkage (10). Despite this progress, important gaps remain, especially for key populations, men, young people and people living with HIV who had been previously diagnosed and had not initiated ART or who had started treatment but had disengaged or been lost to follow-up. Many men remain untested, and those with HIV continue to be diagnosed and linked to treatment and care late: in many settings, men have a higher HIV mortality rate than women (11). For infants who are tested, delays in obtaining results and further losses in the treatment cascade still occur. As a result, less than one third of perinatally infected infants are linked to services and initiate ART in a timely manner (12). Across regions, significant linkage to care disparities exists. Eastern and southern Africa has the largest absolute gap, and eastern Europe and central Asia have the lowest proportions of people who know their HIV status receiving ART.

Linkage to HIV treatment, prevention, care, support and other relevant services is the primary responsibility of HIV testing services and the testers and providers delivering HIV testing services (9). Multiple factors may hinder successful linkage to care, including distance from services, transport costs, long waiting times at the facility and, for those testing positive, stigma and disclosure-related concerns. As programmes expand access to HIV testing services, linkage to HIV care should be improved through interventions that support people in the initial steps in the continuum of care. Such interventions may vary based on the local context, including the health-care delivery systems, geography and target population. A combination of interventions is needed to improve linkage to prevention, care and treatment for specific groups at risk, especially for key populations and men.

Post-test counselling messages remain key. They should be concise, addressing the needs of the client and focusing on supporting linkage to care. Post-test counselling messages need to be tailored to specific populations and their situations and whether their test results are HIV-positive, negative or inconclusive or they already know their status and need to engage or re-engage in care. Messages need to provide clients with the latest information, including:

  • the personal health benefits of early ART;
  • that people living with HIV receiving ART who achieve and maintain viral suppression cannot transmit HIV to their partners; and
  • the benefits of voluntary provider-assisted referral for people living with HIV.

All people with HIV-positive diagnoses should be offered a package of support interventions that ensure timely linkage to care. WHO recommends co-located and well-coordinated ART services and peer support and peer navigation to facilitate linkage. Several other approaches can be considered among specific groups with low linkage rates – such as men, young people and key populations. These approaches could include ART initiation outside the health facility, friendly and flexible services designed to suit these groups and digital platforms such as linkage support via social media and videos.

People who are HIV-negative but at ongoing risk also need to be linked to effective prevention. Post-test counselling messages should include information on HIV prevention interventions and how to access them, such as male and female condoms, PrEP methods, voluntary medical male circumcision for men and boys in eastern and southern Africa and harm-reduction services for people who inject drugs. Once these people are engaged in prevention services, HIV testing services will continue to be part of prevention monitoring – such as regular testing among people taking PrEP – to identify people newly infected so that they can start ART as soon as possible.

For more information on post-test services and linkage to care, see Consolidated guidelines on HIV testing services for a changing epidemic (13) and Chapter 4 in Consolidated guidelines on HIV testing services, 2019 (9).

WHO’s five Cs

The five Cs are principles that apply to all HIV testing services and in all circumstances: consent, confidentiality, counselling, correct and connection.

The last C – connection – states that linkage to prevention, care and treatment services should include the provision of effective and appropriate follow-up as indicated, including long-term prevention and treatment support. Providing HIV testing services where there is no access or poor linkage to care, including ART, has limited benefit for people living with HIV. The providers and testers delivering HIV testing services are responsible for linkage.

Rationale and supporting evidence

The recommendations made in 2016 were supported by a systematic review (3) that identified three main areas of intervention: (1) streamlined services; (2) peer support and navigation and (3) quality improvement approaches.

Streamlined services

The review showed that multifaceted interventions to reduce time between diagnoses and engagement in care and ART initiation were associated with increased rates of ART initiation, including (1) enhanced linkage with case management, (2) support for HIV disclosure, (3) patient tracing for those who failed to engage in care, (4) training staff to provide multiple services and (5) streamlined services to accelerate the time to initiation. Multifaceted, streamlined services may use incentives to improve linkage to care and ART initiation.

Peer support and navigation

The specific interventions evaluated included home visits, peer support, including for navigating the health-care system, and enhanced counselling. The evidence for peer support and navigation interventions was overall of moderate certainty, due either to observational study design or the small number of trials identified. In the reviewed studies, peer navigators assisted people to link from community-based testing services to health-care settings where HIV care is provided.

Quality improvement

Quality improvement interventions have shown benefits for linkage to care, especially for programmes to prevent the mother-to-child transmission of HIV (14). Integrated service delivery – providing ART in TB and maternal, newborn and child health care settings – has been found to reduce time between diagnosis and ART initiation. A qualitative evidence synthesis found that people’s experience of positive interaction with their health-care providers supports linkage to HIV care (15). Disclosure support also positively affected linkage.

Cost and cost–effectiveness

Costs vary depending on the selected intervention and implementation context. Effective linkage to HIV care following an HIV diagnosis potentially improves programme effectiveness, supports earlier ART initiation and reduces loss to follow-up before treatment initiation. None of the studies reported estimates of the cost or cost–effectiveness of support interventions.

Equity and acceptability

A qualitative evidence synthesis identified 25 studies of single and combined interventions to support linkage to care (15). Key areas of convergence included counselling and support interventions that (1) highlight the importance of positive interactions with health-care workers or case managers (high certainty), and (2) family and peer support (moderate certainty). For service delivery interventions, (1) process and discussion of the implementation of interventions (high certainty) and (2) task sharing interventions (high certainty) were all acceptable to improved linkage. HIV programmes need to address barriers to linkage to HIV care and ART initiation. This is especially important for populations that face multiple barriers, both structural and individual, in accessing HIV services.

Feasibility

Several of the interventions are effective in improving linkage and are being implemented in different settings, including use of peer support, which has been found to provide benefits across multiple points in the cascade.

Implementation and population considerations

Pregnant and breastfeeding women

Testing during pregnancy is usually conducted in antenatal care and – unless treatment is also provided at the same location – there is often a high rate of disengagement from care since mothers and health-care workers may be more focused on pregnancy care. Solutions include:

  • integrating HIV and maternal, newborn and child health services, so that testing and treatment are provided in one place; and
  • if integration is not appropriate, such as in low-prevalence settings, using peer support systems to ensure linkage between antenatal care and ART care service may be valuable.

Optimal maternal retesting time points must be considered during pregnancy and postpartum. In settings with a high burden of HIV infection, retesting is advised for all pregnant women with an unknown or HIV-negative status during late pregnancy (third trimester). Catch-up testing is needed if the first test or retest is missed or delayed. Countries with a high burden of HIV infection could consider an additional retest in the postpartum period for specific districts or regions with a high HIV burden or incidence, for women from key populations and women who have a partner living with HIV who does not have suppressed viral loads (9).

Children

There is historically poor retention among children, especially for infants tested using early infant diagnosis within programmes to prevent the mother-to-child transmission of HIV. Solutions include:

  • using point-of-care early infant diagnosis to improve linkage;
  • using SMS, GSM or GPRS printers to speed up the return of results from central laboratories; and
  • using family-centred care service delivery models, in which the mother, her baby and her partner receive care at the same point of care.

Adolescents

Developmental changes during adolescence may mean that not all adolescents have the ability to cope with an HIV diagnosis. Adolescents may also have limited awareness of their own health needs and of the availability of services as well as limited experience and confidence in navigating health services. Consent requirements may restrict access to treatment and care. Solutions include providing adolescent friendly linkage services; mechanisms involving outreach to adolescents such as peer-based interventions; community-based services; other outreach services; support groups; mobile technology, social media or call centres. These linkage mechanisms should be introduced at the point of testing.

Key populations

Key populations have been defined as people who are at increased risk because of specific behaviour compounded by structural challenges such as criminalization, violence and stigma and discrimination which affect their access to health services. For HIV, key populations include men who have sex with men, sex workers, transgender people, people in prison and other closed settings and people who use or inject drugs.

Although the health interventions for key populations do not differ from those of other people at risk of or living with HIV, their access is often compromised and delivery of services may therefore need to be adapted. Involving key populations in designing, implementing and providing services is critical to ensure that the services are offered in a way that they can actually access them.

Community-based service delivery, including through peers, has shown to be more effective in many settings, especially where laws criminalize same-gender sex, sex work or drug use.

Particular issues are relevant for people in prisons and other closed settings. Not only access to high-quality health services when imprisoned as a matter of equity but also because of the major risk of treatment interruptions when transitioning between (and within) prisons and the community. Implementing safety measures to ensure the continuity of care is critical, such as providing several months of treatment to people who move back into the community to address issues of housing, health insurance, health-care provider, etc.

Additional evidence-informed implementation strategies (9)

In contexts, settings and populations with suboptimal linkage, the following additional evidence-informed implementation strategies can be considered:

  • peer and community support and follow-up, including patient navigators and linkage escorts;
  • home-based ART initiation and care;
  • incentives, including financial incentives;
  • friendly and flexible services;
  • new digital platforms; and
  • (re)linking people to treatment and care.

These may be especially useful for supporting the scale-up of self-testing and community-based HIV testing services, most notably home-based and outreach models which could have low linkage rates.

Countries should review their national guidelines and consider including a clear linkage strategy and policy, including specific approaches, interventions and designation of cadres supporting linkage and rapid ART initiation, and monitoring effectiveness. Policies need to support HIV testing services sites and testing providers to support linkage to care, including linking patient unique identifiers and revising HIV testing services registries to include evidence of linkage.

Research gaps

Evaluation of strategies aimed at improving linkage to care are needed to build a stronger evidence base. Future studies should disaggregate effects by gender, key population and age. Costing studies and cost–effectiveness analysis are needed to better inform policy decisions.

Further research is needed on whether and how digital media platforms, especially social media and web-based tools, can be adapted to facilitate linkage and rapid ART initiation at an affordable price. Further research is also needed on strategies to support people living with HIV who already know their status and link them back into care after they decline ART or being lost to follow-up.

In addition, more evidence is required on the feasibility, effectiveness and cost–effectiveness of strategies to link people living with HIV and their sexual or social networks (who have recent or ongoing HIV risk) to HIV prevention services.

7.3. Differentiated service delivery for HIV treatment

In nearly all countries, HIV treatment was delivered in the initial phase of rapid scale-up based on a one-size-fits-all, clinic-based model largely undifferentiated for individual needs (16). As national guidelines have evolved towards comprehensive care, prevention, earlier diagnosis and initiating ART for all people living with HIV, differentiated service delivery for HIV treatment has become a critical component of recognizing the diversity of needs of people living with HIV. Differentiated service delivery, previously referred to as differentiated care, is a person-centred approach that simplifies and adapts HIV services across the cascade in ways that both serve the needs of people living with and vulnerable to HIV and optimize available resources in health systems (17). The principles of differentiated service delivery can be applied to prevention, testing, linkage to care, ART initiation and follow-up and integration of HIV care and coinfections and comorbidities. This section focuses on differentiated service delivery for HIV treatment (see Chapter 2 for service delivery approaches for testing).

As national guidelines have evolved towards initiating ART for all people living with HIV regardless of clinical and immune status, HIV programmes have been challenged to manage an increasingly diverse set of people’s needs. The 2016 WHO consolidated HIV treatment guidelines (3) identified four groups of people with specific clinical needs: individuals presenting or returning to care with advanced HIV disease; individuals presenting or returning to care when clinically well; individuals established on ART; and individuals receiving an ART regimen that is failing (18). Differentiated service delivery for HIV treatment has focused primarily on people who are clinically stable (established on ART – see Box 7.1). Subsequently, the need has been recognized to adapt services for those with advanced HIV disease, high viral load and comorbidities through simplified care packages and differentiated models of service delivery; the principles of differentiating service delivery according to the needs of different groups has also been extended to improving the uptake of HIV testing and prevention.

In addition to considering people’s clinical needs, differentiated service delivery for HIV treatment should also consider the specific populations and contextual settings. For example, differentiated service delivery models should be designed to address the needs of children and adolescents, pregnant and breastfeeding women and key populations. There is also increasing experience of how such models have been adapted in settings with lower HIV prevalence, acute conflict or other emergency responses (19).

Differentiated service delivery for HIV treatment is based on four building blocks (Fig. 7.1). In any given differentiated service delivery model for HIV treatment, the building blocks need to be defined separately for clinical consultations, ART refills and psychosocial support.

Since 2016, several countries have adopted and scaled up differentiated service delivery as part

Fig. 7.1. The building blocks of differentiated service delivery for HIV treatment.

Fig. 7.1

The building blocks of differentiated service delivery for HIV treatment.

of national policy, especially in sub-Saharan Africa and for adults established on ART (20). The definition of being established on ART (stability) should be applied to all populations, including those receiving second- and third-line regimens, those with controlled comorbidities, children, adolescents, pregnant and breastfeeding women and key populations. These populations often represent specific cohorts in which retention and suppression of viral loads has been challenging and hence may benefit more from differentiated service delivery for HIV treatment models adapted to their needs (21).

Box 7.1Criteria for determining whether a person is established on ART

To support the implementation of these recommendations, WHO has developed criteria for determining whether a person has been successfully established on ART:

  • receiving ART for at least six months;
  • no current illness, which does not include well-controlled chronic health conditions;
  • good understanding of lifelong adherence: adequate adherence counselling provided; and
  • evidence of treatment success: at least one suppressed viral load result within the past six months (if viral load is not available: CD4 count >200 cells/mm3 (CD4 count >350 cells/mm3 for children 3-5 years old) or weight gain, absence of symptoms and concurrent infections).

The provision of ART should not depend on receiving other services. Differentiated service delivery for HIV treatment aims to enable clinical consultations to be carried out separately from other visits such as visits for ART refills and/or, if appropriate, psychosocial support. As outlined above, the building blocks for clinical consultations may differ from those for ART refills or psychosocial support. Psychosocial support may be aligned with clinical consultation and ART refill visits or may be provided separately through additional community and peer support systems. Multi-month refills and dispensing may be used alone or within any of the four categories of differentiated service delivery for HIV treatment listed below, each of which provides additional benefits to both the health system and clients. Multi-month refills may also be used for children older than two years, since dosage is adjusted less frequently beyond that age (21). The recommendations on the frequency of clinical visits and ART refills are outlined in Chapter 5 (21).

Differentiated service delivery models for HIV treatment described in practice and the literature can be described within four categories:

  • group models managed by health-care workers;
  • group models managed by clients;
  • individual models based at facilities; and
  • individual models not based at facilities.

The most common example of a group managed by health-care workers is the ART adherence club. In a South African study including 3216 people across a large urban district, adherence club retention was 95% at 12 months and 89% at 24 months (22). Most recipients of care remained in care (87%) and had suppressed viral loads (94%) up to three years after entering an adherence club, with attendance highly protective against disengagement (23,24) compared with conventional care. Adherence club members receiving six-monthly ART refills had similar 24-month retention (93% versus 94%), higher viral load completion (94% versus 89%) and similar viral load suppression (96% versus 98%) versus those who received standard care (two-monthly refills and then four months at the end of the year) (25). In Zambia, rates of late drug pick-up are lower among participants in urban adherence clubs than among clinic-based participants. This model has also been demonstrated to be acceptable to both health-care workers and clients (26) and cost-effective (27). Positive outcomes of groups managed by health-care workers in terms of improved retention and viral suppression have also been reported across populations, including adolescents (28), children and their caregivers (29), postnatal women (30), men who have sex with men (31) and for those who have previously struggled with adherence, demonstrating the benefits of such a group approach to achieve and maintain viral suppression among people with previous non-suppressed viral loads (32).

Groups managed by clients meet at an agreed community location and nominate a member to collect ART for the group on a rotating basis. Common examples include community adherence groups, community ART refill groups and community client-led ART delivery. Data from client-managed group models have shown improved retention across a range of settings in sub-Saharan Africa (3335). Qualitative evidence supports reduced costs, especially from the client perspective, and increased time savings and benefits from the peer support available within this group model (27,3639). Health-care workers favoured client-managed groups because they can decongest the clinics and reduce workload (40,41). Client-managed groups have also been implemented for family groups, key populations (40) and in unstable settings to support adherence (37,42,43).

Individual models based at facilities are commonly known as fast-track or quick pick-up and go beyond extending the ART refill duration. Assigning a specific place (such as direct pick-up from a pharmacy) and time for ART refills that does not involve consultation with a health-care worker for clinical review or scripting minimizes time spent at the clinic. Evidence from such fast-track models has demonstrated reduced waiting times (44,45), reduced missed appointments (46) and reduced costs from a limited societal and health ministry perspective (47). A positive impact on retention and suppression of viral loads has also been documented. In Malawi, retention at five years after enrolment in a six-monthly appointment fast-track model was >86% versus 47% among those who were eligible but did not enrol (48). In Zambia, those in the fast-track model were more likely to be retained at 12 months (relative risk (RR) = 1.52) and maintain viral suppression (RR = 1.07) (49). The benefits of this approach have also been demonstrated in low-prevalence (50) and politically unstable settings (43) and for children (51,52). A study of extended ART refills for more than 22 000 children across six sub-Saharan African countries found that 66% had their ART refills extended beyond one month. Of those with extended refills, only 2.6% were lost to follow-up and 2% died; suppression of viral loads remained high over five years, ranging by year from 79% to 85% (51).

Individual models outside facilities vary according to where in the community services are provided and by whom. They can be divided into fixed community points (including private or community pharmacies), mobile outreach ART delivery and home delivery. High retention has been reported from several countries, including the Democratic Republic of the Congo, South Africa, Uganda and Zambia (5356). In the Democratic Republic of the Congo, ART refills are provided from community sites run by treatment-literate peers. Fixed community ART delivery points have also provided six-month ART refills (34) and been implemented for children (57) and key populations via drop-in centres (58). Home delivery of ART has been studied in Kenya, South Africa and Uganda, with mixed results on retention and mortality (59,60). In settings in which costs were analysed, health service and patient costs were lower for home delivery than for facility care (61). The relevance of home delivery within the model mix is context specific in relation to feasibility for the health system and factors such as distance and stigma. Less published evidence is available for mobile outreach approaches, but this approach does have the potential to support an integrated approach to the community delivery of other health services.

A recent rapid systematic review of literature documenting the outcomes of differentiated service delivery for HIV treatment (59) included 29 publications. Of the 37 models described, seven (19%) were facility-based individual models, 12 (32%) individual models based outside facilities, five (14%) groups led by clients and 13 (35%) groups led by health-care workers. When a comparison with conventional care was provided, retention in most differentiated service delivery models was within 5 percentage points of that for conventional care; when no comparison was provided, retention generally exceeded 80%. For suppression of viral loads, all those with a comparison to conventional care reported a small increase in suppression in the differentiated service delivery model; reported suppression exceeded 90% in 11 of 21 models (62).

A review of the available literature suggests that differentiated service delivery for HIV treatment for those who are established on ART saved patients substantial money on travel costs and greatly reduced the time required to receive ART, including time spent on transport, waiting in the queue or having a clinic visit, and modestly reduced the resources the health system used (27).

7.4. People-centred care

Good practice statement (2021)

Health systems should invest in people-centred practices and communication, including ongoing training, mentoring, supportive supervision and monitoring health-care workers, to improve the relationships between patients and health-care providers.

Source: Updated recommendations on service delivery for the treatment and care of people living with HIV (63)

Good practice statements (2016)

HIV programmes should:

  • provide people-centred care that is focused and organized around the health needs, preferences and expectations of people and communities, upholding individual dignity and respect, especially for vulnerable populations, and engage and support people and families to play an active role in their own care by informed decision-making;
  • offer safe, acceptable and appropriate clinical and non-clinical services in a timely fashion, aiming to reduce morbidity and mortality associated with HIV infection and to improve health outcomes and quality of life in general; and
  • promote the efficient and effective use of resources.

Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach – second edition (3)

Background and rationale

People-centred health services are an approach to care that consciously adopts the perspectives of individuals, families and communities and sees them as participants and beneficiaries of trusted health systems that respond to their needs and preferences in humane and holistic ways (3). This approach acknowledges the experiences and perspectives of health-care providers that may enable or prevent the delivery of people-centred care that is of high quality (64).

In HIV care, several studies have shown that people are willing to travel longer distances to consult a health-care provider with a respectful and caring attitude, and negative health-care worker attitudes contribute to loss to care and poor programme outcomes (6567). For key populations in particular, experiencing stigma and discrimination in health-care settings is a structural barrier to accessing services (68,69). WHO recommends addressing stigma and discrimination in health-care settings as an important component of ensuring access to HIV care (70).

A systematic review was conducted to identify practical ways to enhance people-centred care for people living with HIV (71) (Box 7.2). The review identified 15 studies describing intervention strategies including adults, adolescents (72) and children and the following key population groups: sex workers, men who have sex with men, transgender people and people who inject drugs.

Box 7.2Interventions to improve relationships between patients and health-care providers

Interventions that were found to improve relationships between patients and health-care providers could be classified into the following approaches:

  • providing friendly and welcoming services:

    such as through training providers to make general HIV services more welcoming, providing adolescent-friendly services outside school hours and training providers to welcome patients back into care;

  • conducting sensitization training for clinical and non-clinical health-care providers to improve care for key populations:

    both at the primary care and community levels, which includes issues related to stigma and discrimination;

  • offering individualized adherence counselling and patient-centred communication:

    such as shared decision-making and planning for ART initiation and adherence and supporting change in provider attitudes towards those who have disengaged from care;

  • facilitating client education in empowerment and communication skills; and
  • providing feedback to health-care workers on patient concerns and evaluation of service quality:

    such as community score cards, patient feedback mechanisms combined with quality improvement exercises.

Overall, studies reported beneficial effects of these approaches across the HIV cascade including improved ART uptake, adherence and suppression of viral loads.

The Guideline Development Group formulated a new good practice considering the indirect evidence showing that a health system–based perspective and providing a variety of people-centred practices will improve relationships between patients and health-care providers. Providing tools to improve people-centred services may reduce stigma, discrimination and violence against people living with HIV, especially among women, transgender people and other vulnerable groups. Health-care providers should be trained appropriately to ensure that, in addition to improving relationships with patients, they are also capable of supporting women and vulnerable groups in responding to gender or intimate partner violence and in accessing sexual health counselling and support.

7.5. Initiating and maintaining treatment

7.5.1. Initiating ART outside the health facility

Recommendation (2021)

ART initiation may be offered outside health facilities (conditional recommendation, low- to moderate-certainty evidence).

This recommendation is additional to routinely offering ART initiation at health facilities.

Source: Updated recommendations on service delivery for the treatment and care of people living with HIV (63)

Background and rationale

Community-based HIV testing approaches are a key component of any HIV testing strategy (9). In most settings, if a positive HIV diagnosis is made in the community – for example through mobile health services, community centres, services focusing on key populations and patients’ homes – the individual is then referred to a health centre to start treatment (9).

WHO recommends rapidly initiating ART, including starting on the same day of a positive diagnosis, partly because of the large losses previously observed between diagnosis and initiation (18).

Losses to care between community HIV testing and ART initiation are substantial: a systematic review of studies in sub-Saharan Africa found that the proportions linked to care could be as low as 14% for home-based testing and 10% for community-based testing; in some settings, less than one quarter were known to have started treatment (73). The reported reasons for not initiating treatment can include feeling healthy, insufficient social support, HIV stigma, high care-seeking costs and incomplete knowledge of treatment benefits (74). This is of particular concern for vulnerable populations such as women, young girls and key populations, who have a heightened risk of stigma, discrimination and violence. WHO has provided recommendations on how national programmes should work to protect these populations (70,75). A study from South Africa and Zambia found that people testing positive in the community often delayed starting ART because of issues related to the quality of care (including long waiting times, lengthy initiation procedures and lost clinic folders) and the stigma associated with accessing care (76). Other studies have cited lack of time (77) and concern about long clinic waiting times as the main reported reasons for not linking to care and starting treatment (78).

A systematic review identified three randomized trials and four observational studies providing evidence that offering ART initiation outside the health facility was associated with an increase in the proportion of people starting ART (RR 1.86, 95% CI 1.29–2.68), increased retention in care at 6–12 months following ART initiation (RR 1.44, 95% CI 1.33–1.56) and increased suppression of viral loads (RR 1.31, 95% CI 1.13–1.61) (79); two studies included in this review included key populations (80,81), and one study included adolescents and young adults (82).

Benefits and harm

Early initiation of ART is associated with several health benefits, including reduced mortality and morbidity and reduced onward transmission (83). The offer to start ART before referral to a health facility has the potential to reduce delays in starting treatment for individuals who are unwilling or unable to be referred to the health facility to start treatment. Although the studies that assessed community ART initiation reported no intervention-specific harm, ensuring that baseline assessments and support are provided either as part of the intervention or on referral to the health facility is important.

Feasibility, cost and cost–effectiveness

When ART initiation is included as a component of existing community activities, additional expertise and resources are needed, as reflected by the studies (78). A randomized trial of community-based ART in South Africa and Uganda included an activity-based microcosting study to estimate the annual per-client cost of community-based ART initiation. The study concluded that community-based ART could cost US$ 275–452 per person with suppressed viral loads, slightly more than the US$ 214–422 per person with suppressed viral loads estimated for the facility-based initiation group (84). Another study, from Malawi, assessed optional home initiation of ART following HIV self-testing and found that the average annual cost per participant who initiated ART was US$ 172 versus an annual cost of providing ART in facilities of US$ 858–1165 (85).

Equity and acceptability

Implementing this recommendation could potentially increase access to treatment for individuals who may experience structural barriers such as criminalization, stigma and discrimination when attempting to access health-care services to initiate treatment. A study among female sex workers in the United Republic of Tanzania found that those receiving community ART initiation were more likely to have started treatment and be retained in care and less likely to have interrupted treatment or feel high levels of internalized stigma (81,86). Evidence for adolescents was limited, and the acceptability is uncertain.

Implementation considerations

Confirmatory HIV testing needs to be ensured before ART initiation, consistent with HIV testing guidance that a single reactive test always needs confirmation (9) (see Chapter 2). WHO guidelines recommend a readiness assessment when starting ART, including ART literacy, and clinical assessment that includes CD4 cell count enumeration to determine whether a person has advanced HIV disease and requires further diagnostic investigation and provision of prophylaxis (18). WHO further recommends that nurses be able to initiate ART (3), and this should be facilitated by supportive professional regulations and relevant policies at the national level.

Clients starting ART outside a health facility should be linked to a facility and enrolled in a long-term model of care. ART initiation should also be accompanied by appropriate counselling to ensure that individuals understand the importance of lifelong adherence and receive appropriate support. For those who are not ready to start, referral for care should be provided. Initiating ART outside a health facility needs to be accompanied by appropriate measures to ensure that risk assessment and counselling support are provided, including at the time of initiation and in the period thereafter. Additional practical advice may need to be provided on the administration and storage conditions of ARV drug formulations for infants and younger children; community health-care providers should be trained to provide effective counselling to caregivers to support such requirements (87). In addition, ensuring that adolescents are linked to psychosocial care and that children and parents are supported with disclosure and age-appropriate treatment literacy is important.

Implementation of community ART initiation should consider health system requirements for supporting ART delivery at the community levels, including adequate drug supply, laboratory services, training and supervising health personnel, providing preventive therapy and referral mechanisms for those who need higher-level care. Such adaptations may require a phased approach (for example, by starting implementation in settings in which community prevention and testing activities have been established). The provision of community HIV care should be included in national initiatives to ensure the quality of care.

Research gaps

Research is needed to improve understanding of client preferences about where to start ART and how to link to care by age, population and setting (88,89). Tools to support initiation outside the health facility need to be identified and evaluated. Evidence shows substantial variability in the size of the community treatment team, and implementation research would be valuable in defining the optimum staffing complement and minimum set of skills required. Evidence on how ART initiation outside the facility affects household spending and catastrophic costs would also be of value.

7.5.2. Rapid initiation of ART, including same-day start

Recommendations (2017)

Rapid ART initiationa should be offered to all people living with HIV following a confirmed HIV diagnosis and clinical assessment(strong recommendation: high-certainty evidence for adults and adolescents; low-certainty evidence for children).

ART initiation should be offered on the same day to people who are ready to start (strong recommendation: high-certainty evidence for adults and adolescents; low-certainty evidence for children).

Source: Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy (18)

a

Rapid initiation is defined as within seven days from the day of HIV diagnosis; people with advanced HIV disease should be given priority for assessment and initiation.

Good practice statement (2021)

The offer of same-day ART initiation should include approaches to improve uptake, treatment adherence and retention such as tailored patient education, counselling and support.

Source: Updated recommendations on service delivery for the treatment and care of people living with HIV (63)

Background and rationale

In 2017, WHO strongly recommended that rapid ART initiation be offered to all people living with HIV following a confirmed HIV diagnosis and clinical assessment, with the offer of same-day start for people who are ready (12). This recommendation was supported by evidence showing that rapidly initiating ART leads to an increased likelihood of starting treatment and improved suppression of viral loads and retention in care and may lead to reduced mortality (90). WHO also strongly recommends that nurses be able to initiate and maintain ART (3).

The uptake of this recommendation in national policy is variable. Several countries have not adopted this recommendation in national guidance, and some (91) but not all (92,93) studies have reported poorer retention in care when ART is started on the same day compared with less rapid ART initiation. Patient perspectives have highlighted the importance of good counselling and non-judgemental, respectful personnel (94).

A systematic review was conducted to identify approaches that support accelerating the offer or uptake of ART after diagnosis among people living with HIV. The review identified 26 studies; 11 were conducted in general populations and three among pregnant women, 10 included key populations (seven included men who have sex with men, two people who inject drugs and one female sex worker) and two included adolescents.

Many strategies were examined, and these could be classified into (1) strategies targeting clients, (2) strategies targeting health-care providers and (3) strategies targeting the health system. Evidence indicated that all these approaches were associated with increased uptake of ART, suppression of viral loads at 12 months and retention in care at 12 months (95).

The systematic review identified a diversity of interventions to improve uptake and outcomes following same-day ART initiation; some of these interventions provided indirect evidence of benefit for other aspects of HIV care. This diversity of direct and indirect evidence provided high certainty in the overall benefit of providing approaches to improve uptake, treatment adherence and retention, and this led the Guideline Development Group to make a good practice statement. It was considered important to highlight strategies targeting clients, health care providers, and the health system. The most commonly assessed interventions are detailed in Table 7.1.

Table 7.1. Evidence-informed approaches to supporting same-day ART initiation at the level of the client, provider and health system.

Table 7.1

Evidence-informed approaches to supporting same-day ART initiation at the level of the client, provider and health system.

7.5.3. Frequency of clinical visits and ART pick-up

Recommendations (2021)

People established on ART should be offered clinical visits every 3–6 months, preferably every six months if feasiblea (strong recommendation, moderate-certainty evidence).

People established on ART should be offered refills of ART lasting 3–6 months, preferably six months if feasibleb (strong recommendation, moderate- to low-certainty evidence).

Source: Updated recommendations on service delivery for the treatment and care of people living with HIV (63)

a

When routine clinical consultations are due, they should be coordinated with planned medicine pick-ups to reduce visit frequency.

b

ARV drug supply management should be strengthened to ensure the availability of ARV medicine and prevent stock-outs in the context of less frequent medication pick-ups.

Background and rationale

In 2016, WHO recommended clinical visits every 3–6 months and dispensing ART lasting 3–6 months for people established on ART (3). Two distinct recommendations were made to underscore the point that clinical visits and medication pick-up should be considered separately. These recommendations have been broadly adopted by national guidelines, with clinical visits and medication pick-up every three months most commonly adopted according to country surveys (51,96).

A systematic review assessed the evidence on outcomes associated with different frequencies of clinical visits and refills of ART (97). The review identified three randomized trials and three observational studies comparing clinic visit frequency at three and six months and found no difference in retention in care (RR = 0.99, 95% CI 0.94–1.03, low-certainty evidence) or suppression of viral loads (RR = 1.02, 95% CI 0.86–1.21, low-certainty evidence). The review also identified three studies, including one randomized trial, comparing ART dispensing frequency and found no difference in retention in care (RR = 1.00, 95% CI 0.98–1.02, moderate-certainty evidence); suppression of viral loads at six months was marginally reduced in one study (35) but similar in the other two studies (55,98). One study across six African countries reported that children and adolescents who transitioned to multi-month prescribing maintained favourable outcomes in terms of death, retention, adherence, immunosuppression and suppression of viral loads (51).

Benefits and harm

For people living with HIV who are established on ART, a frequency of clinical visits and dispensing of ART of 3–6 months is associated with improved outcomes compared with monthly schedules. The certainty of the evidence was low to moderate. Some of the evidence supporting these recommendations came from observational studies with methodological limitations, and there was important variability in outcomes across studies. No harm was identified.

Feasibility, cost and cost–effectiveness

Many countries have adopted the previous WHO recommendation of clinic visits and ART dispensing every 3–6 months, demonstrating feasibility across a diversity of settings (51,96). WHO has also recommended reducing client contact with health services as a way to maintain essential health services during periods of service disruption (99). Differentiated service delivery for HIV treatment, including reduced visit frequency and increased ART refills, saves substantial patient travel costs and greatly reduces the time required to receive ART, including time spent on transport, waiting in the queue or having a clinic visit (100). Reducing the visit frequency also reduces health system costs, making this a cost-saving intervention.

Equity and acceptability

A review of relative patient preferences among adults living with HIV found that, compared with monthly drug refills, people living with HIV preferred longer intervals but showed no strong preference for three-month compared with six-month refill frequency (67). The Guideline Development Group judged that providing the option of less frequent health service interaction has the potential to increase equity by improving opportunities to access care for vulnerable and mobile populations.

Implementation considerations

Reducing the frequency of drug dispensing requires adequate drug supply and the possibility for appropriate storage for clients, including for community ART delivery. Consideration should be given to harmonize and optimize scheduling while ensuring patient choice and linkage to other key services, including viral load and other laboratory investigations and dispensing of medications for TB preventive treatment and chronic conditions. Extended refills should be considered for children older than two years when the dose is adjusted less frequently (21), since younger children need to attend health services for routine services such as immunization. Additional models of community support may need to consider clinic visits for certain groups at greater risk of facing adherence challenges and those at increased risk of other conditions as a result of complications from pregnancy, such as members of key populations, adolescents and pregnant and postpartum women as well as individuals or groups requiring special care to prevent or treat pregnancy-related risks, illness and death.

Research gaps

Evidence is needed on outcomes associated with less frequent clinical visits and/or drug refills (beyond six months) for various populations. In particular, there are contexts in which annual clinical visits are the standard of care and may both benefit clients and reduce costs for health systems.

7.5.4. Adherence support

Recommendation (2016)

Adherence support interventions should be provided to people receiving ART(strong recommendation, moderate-certainty evidence).

The following interventions have demonstrated effectiveness in improving adherence and suppression of viral loads:

  • peer counsellors (moderate-certainty evidence);
  • mobile phone text messages (moderate-certainty evidence);
  • reminder devices (moderate-certainty evidence);
  • cognitive behavioural therapy (moderate-certainty evidence);
  • behavioural skills training and medication adherence training (moderate-certainty evidence); and
  • fixed-dose combinations and once-daily regimens (moderate-certainty evidence).

Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach – second edition (3)

Background

Adherence to ART is the primary determinant of whether viral loads are suppressed and of the risk of transmission, disease progression and death (101103).

Suboptimal adherence is a major challenge worldwide and is associated with a diversity of individual, interpersonal, community and structural factors. The most frequently reported individual barriers across all age groups include forgetting, being away from home and a change to daily routine. More than 15% of the people receiving ART report that depression is a barrier to adherence across all age categories, and adults and adolescents commonly report alcohol and substance misuse as a barrier. With respect to contextual barriers, secrecy or stigma is a commonly cited barrier to adherence, reported by more than 10% across all regions. Health service–related barriers are frequently reported, including distance to the clinic and stock-outs (104). Specific population groups that face additional challenges to adherence include pregnant and postpartum women, adolescents, infants and children, key populations and people with mental health and substance use disorders.

Rationale and supporting evidence

A systematic review and network meta-analysis identified 85 randomized trials of interventions to improve adherence (105). The review found moderate-certainty evidence that peer counselling results in improved adherence and suppression of viral loads. Peer-based interventions are generally well accepted, especially among adolescents who find that hearing experiences and learning from others facing the same challenges are critical for supporting adherence and engagement in care. Other interventions found to significantly improve adherence include SMS messages and cognitive behavioural therapy.

Supportive interventions

Several interventions may be of value in addressing specific challenges that affect adherence and/or suppression of viral loads (see the recommendations above).

Nutritional support

Nutritional assessment, care and support are essential components of HIV care. Studies have shown that severe food insecurity predicts disengagement from care, and persistent severe food insecurity is associated with suboptimal adherence to ART and failure to suppress viral loads (106,107). Providing nutritional support to people receiving ART can reduce the risk of non-adherence among food-insecure individuals (15,108). HIV programmes should ensure that existing national policies on nutritional support are observed to maximize adherence to ART and achieve optimal health outcomes, especially in food-insecure settings. Nutritional support could include nutritional counselling, cash transfers, subsidizing food costs and/or food vouchers.

Financial support

Financial support can reduce the risk of non-adherence and improve viral suppression (109111). Programmes and care providers should consider a broader programmatic approach for reducing the costs of care for people living with HIV that includes avoiding out-of-pocket payments at the point of care (including drugs, diagnostics and clinical services), supporting transport costs, decentralizing care and reducing the frequency of health facility visits. Programmes need to consider the ethical and equity implications of providing financial support and non-monetary incentives for people living with HIV. Standardized criteria for supporting people receiving ART may need to be developed based on national income levels.

Implementation and population considerations

Pregnant and postpartum women

The pregnancy and postpartum period presents significant biological, social and economic challenges that may affect treatment adherence. An estimated one quarter of pregnant women have inadequate ART adherence, and this is higher during the postpartum period (112). Pregnancy-related conditions such as nausea and vomiting may negatively affect treatment adherence. Additional factors also include required care for a positive pregnancy experience, in which antenatal care models recommend a minimum of eight contacts with the health system to reduce perinatal mortality and improve women’s experience of care. Pregnant women must be given choice of where to receive ART care, but this should be carefully coordinated with the required antenatal care contacts to avoid missed opportunities to obtain both high-quality and patient-centred antenatal care and ART care. Other individual factors include suboptimal understanding of HIV, ART and interventions to prevent mother-to-child transmission, lack of disclosure to the partner, family and community, disclosure and fear of stigma and discrimination (113). Service delivery barriers include poor-quality clinical practices, gaps in provider knowledge and training, poor access to services and health-care worker attitudes (114,115).

Adolescents

Achieving optimal ART adherence and viral suppression outcomes remain a major challenge among adolescents and youth (116). An estimated 38% of adolescents globally are suboptimally adherent to ART, with substantial regional variation (117). In addition to common challenges to adherence, adolescents face specific challenges such as peer pressure, the perceived need to conform and inconsistent daily routines (118,119). Secrecy and stigma have been reported as important causes of suboptimal adherence among adolescents, with caregiver support, peer support groups and knowledge of HIV status reported as facilitators (104,120). For adolescents who are transitioning from paediatric to adolescent care, additional challenges may include assuming increased responsibility for their own care, issues relating to disclosure to peers or partners, difficulties in navigating the health-care system, lack of links between adult and paediatric services and inadequately skilled health-care providers (121).

Infants and young children

Successfully treating a child requires the commitment and involvement of a responsible caregiver. Parents and other family members of children living with HIV may themselves be living with HIV, and suboptimal HIV care and treatment for family members could result in suboptimal care for the child. Other challenges include lack of nutrition support, limited choice of formulations for children, poor palatability of liquid formulations, high pill or liquid volume burden, large pill size, frequent dosing requirements and difficulties in swallowing tablets (104,122125).

Mental health and substance use

People living with HIV with uncontrolled depressive symptoms are more likely to have poor adherence to ART (126). Depression and anxiety disorder are among the most common mental health disorders associated with suboptimal ART adherence (127129). Adherence is complicated by mental health comorbidity that results in forgetfulness, poor organization and poor comprehension of treatment plans. Counselling for HIV and depression and appropriate therapies for people with mental health disorders can help to improve adherence.

Use of alcohol and other substances may also contribute to poor adherence to ART. Alcohol and substance use can lead to forgetfulness, poor organization and diversion of monetary resources (130,131). Treating people for depression and managing substance use disorders can improve HIV treatment outcomes (132). WHO recommends treating people with depression and substance use disorders regardless of HIV status. Other key services for people living with HIV who use drugs, such as needle and syringe programmes and drug substitution therapy, provide further opportunities to support adherence.

Key populations

In many settings, key populations face multiple challenges related to stigma and discrimination that can affect access to health services, all of which may negatively affect adherence (133,134). Service delivery approaches to improve engagement in care for key populations, including peer support, are a critical gap.

7.5.5. Monitoring adherence to ART in routine programme and care settings

Good practice statement (2021)

Viral load for treatment monitoring should be complemented with non-judgemental, tailored approaches to assessing adherence.

Source: Updated recommendations on service delivery for the treatment and care of people living with HIV (63)

Background and rationale

WHO strongly recommends that adherence support interventions be provided to people receiving ART (3). Viral load monitoring is the gold standard for monitoring adherence and confirming treatment response. Other approaches to monitoring adherence should be considered as a way to provide additional information about the risk of failure to suppress viral loads or to support daily tablet-taking behaviour in settings in which viral load testing is not available. Knowledge of adherence can support decisions about whether a recipient of care is eligible for simplified models of service delivery and whether to switch treatment regimens when viral load is unsuppressed.

WHO further recommends that, following an initial high viral load (exceeding 1000 copies/mL), an enhanced adherence intervention should be carried out before conducting a second viral load test. This has been shown to lead to resuppression for about half the people receiving ART, avoiding unnecessary switching of treatment (135).

Simple, affordable measures suggested by WHO to measure adherence include pill counts, pharmacy refill records and self-reporting (Box 7.3) (136). A systematic review identified 50 studies to assess the comparative diagnostic accuracy of these adherence measures (137). Overall, the review found that all adherence measures had low sensitivity for identifying people who are non-adherent and have unsuppressed viral loads. For self-report, asking five or more questions as part of the assessment tended towards providing higher sensitivity in diagnosing viral non-suppression. Composite adherence measures, such as combining self-report with pharmacy refill or tablet count, appeared to provide higher sensitivity.

The Guideline Development Group determined that adherence measures have clear value as an opportunity to discuss issues relating to treatment with people receiving ART and to identify potential barriers to maintaining adequate adherence and areas in which support may be needed.

Box 7.3Simple, low-cost approaches for measuring adherence

Pharmacy refill records provide information on when people pick up their ARV drugs. Some studies (138140) have found that pharmacy records are a more reliable measure than self-reported adherence.

Self-reported data are easy to collect and can be a useful adjunct to estimating non-adherence but are subject to recall bias (136). Counselling on the importance of remembering ART doses and an environment that promotes and enables honest reporting of non-adherence are critical components. Self-report has been found to be a more reliable predictor of failure to suppress viral loads when the recall period was within one week (141).

Pill counts may help to assess adherence. Pill counts may not be feasible in routine care settings. Pill count has been found to perform better when combined with self-reported adherence (142).

A key value of all these approaches is that they encourage discussions about adherence with people receiving ART.

Specific population groups face additional challenges to adherence, and these should be considered when implementing the recommended interventions. People receiving ART face a range of individual, interpersonal, community and structural barriers to adherence, including issues related to social identity, gender norms, stigma and medical pluralism; unwelcoming health services; and the need for emotional, practical or financial support for long-term engagement and adherence (104,111).

Effective monitoring of adherence requires a combination of approaches based on human and financial resource capacity, acceptability to people living with HIV and health-care workers and understanding of the local context.

Research gaps

Further research is needed to determine:

  • optimal ways to proactively monitor adherence and identify through simple triage the people in greatest need of adherence support;
  • the most accurate measures of adherence to ART that are feasible in settings with limited resources to complement viral load testing;
  • interventions to support adherence in populations at heightened risk of suboptimal adherence (children and adolescents, pregnant women, men who have sex with men and people who inject drugs);
  • potential synergistic effects of combining two or more interventions that could affect individual, social support and health system factors; and
  • the effectiveness of long-acting ART in improving adherence and suppression of viral loads.

7.6. Continuity of care

7.6.1. Retention in care

Recommendation (2016)

Programmes should provide community support for people living with HIV to improve retention in HIV care (strong recommendation, low-certainty evidence). The following community-level interventions have demonstrated benefit in improving retention in care:

  • a package of community-based interventionsa (children: low-certainty evidence; adults: very low-certainty evidence);
  • adherence clubsb (moderate-certainty evidence); and
  • extra care for high-risk people (very-low-certainty evidence).

a

Patient advocates, treatment and peer support interventions providing adherence and psychosocial support in the community.

b

Peer support, distribution of ARV drugs and assessment by non-clinical or lay health-care providers. Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach – second edition (3)

Background

Disengagement from care undermines programme and patient outcomes. Data from programmes across sub-Saharan Africa shows that, five years after starting ART, almost a fifth (19%) had stopped ART and 15–20% had died (4,143). Retention in ART programmes is a major challenge in all settings and across populations, specifically children and adolescents, postpartum women and men (144). Multiple factors may play a role in disengagement from care, including male sex, unemployment, lower educational status, advanced HIV disease, poor adherence, nondisclosure, distance from a clinic and lack of understanding of the need for lifelong care (145).

Rationale and supporting evidence

A systematic review identified seven studies (one individual randomized controlled trial, one cluster-randomized controlled trial and five cohort studies) that evaluated community-level interventions to strengthen retention in HIV care: a package of community-based interventions, adherence support clubs and providing extra care for high-risk patients (146). A strong recommendation was made despite low-certainty evidence because the balance of benefit greatly outweighed the potential harm, the degree of acceptability to people living with HIV and the programmatic benefits of implementing interventions that result in positive patient and programmatic outcomes.

Package of community-based interventions

Community-based interventions identified as benefitting retention in HIV care included: support centred on the needs of the individual, counselling and psychosocial support by lay adherence counsellors or patient advocates and family and peer support. Lay counsellors or patient advocates assisted with linking health facilities with communities, providing counselling and patient-centred support and visiting people in their home environment. One cohort study included children and adolescents (younger than 16 years) and demonstrated significantly increased retention at 36 months (147).

Adherence clubs

A systematic review identified one cohort study evaluating how facility-based adherence clubs affected loss to follow-up or death at 40 months, with a significant reduction compared with standard care (148). More recent studies have reported outcomes of adherence clubs that are equivalent to or better than standard care, including for adolescents and postpartum women (25,55,149,150).

Extra care for people with advanced HIV disease

The systematic review identified one cohort study from Kenya that evaluated how nurses and non-clinical health-care workers providing weekly or biweekly contact with people with advanced HIV disease (defined in the study as CD4 count <100 cells/mm3) affected mortality (151). These patients met a non-clinical health-care worker for brief assessment and were referred to a nurse where necessary, in addition to peer support and distribution of ART every two months and a yearly follow-up review with a clinician. Long-term follow-up and death were significantly reduced at 40 months. A trial from the United Republic of Tanzania and Zambia found that people with advanced HIV disease who were given early adherence support together with diagnostics for TB and cryptococcal meningitis had better retention and survival than those receiving standard care (152).

Cost and cost–effectiveness

The cost of implementing community-level interventions varies by setting and depends on whether community-based health programmes are already established. Generally, costs related to training and remunerating lay health-care providers are much less than the cost of care provided at the facility level and care provided by health-care workers. Costs related to community support, peer support and support by patient advocates are often related to training and orienting these cadres and support groups.

Equity and acceptability

A qualitative evidence synthesis highlighted key interventions that were acceptable in improving retention (153). These included lay health-care workers providing support (moderate certainty), especially if they were also living with HIV; family and friend support (moderate certainty); mobile health interventions (moderate certainty) and developing positive and non-judgemental relationships with those implementing the intervention (moderate certainty).

Population considerations

Pregnant and breastfeeding women

For pregnant women living with HIV, the transition from antenatal care and maternal, newborn and child health services to ART care is a potential point for loss to follow-up. A systematic review identified 10 studies (one cluster-randomized controlled trial, three individual randomized controlled trials and six cohort studies) that evaluated interventions to improve postpartum retention of women living with HIV (154). Most of the studies reported outcomes in the immediate postpartum period. Moderate-certainty evidence supported using phone calls and SMS messaging to improve retention in the early postpartum period (6–10 weeks), but long term outcomes were not reported. Evidence on the cost–effectiveness of interventions to improve retention in care of postpartum women is also very limited. Several reviews report positive effects of various mHealth approaches and associated technologies are low cost (155158).

The period of transition from maternal, newborn and child health services to HIV care clinics is often a critical point in which many women and their infants discontinue care. Several countries are implementing interventions with evidence of benefit, including assigning district-level focal points, active patient tracing and financial support for transport. Many programmes are implementing community-based interventions: peer support such as mothers-to-mothers programmes and peer adolescent support groups for adolescent pregnant women living with HIV. Structured counselling sessions and telephone reminders may also potentially support the process of transition.

An increasing number of women living with HIV who become pregnant are clinically stable on ART and access their care through a differentiated ART delivery model. While they are pregnant and during the early postpartum period, these women require additional health-care visits. They should have the choice to continue receiving their ART through the differentiated ART delivery model or to have their ART delivery integrated within their maternal, newborn and child health care. Notably, additional criteria are specific to pregnant and breastfeeding women who choose to access ART in models outside their maternal, newborn and child health care (Box 7.4) (21).

Box 7.4Additional eligibility criteria specific to pregnant and breastfeeding women for accessing differentiated ART delivery models outside clinic care

  • Women clinically established on ART when conceiving: already accessing the differentiated ART delivery model plus at least one viral load test of <1000 copies/mL in the past three months and accessing antenatal care.
  • Women initiating ART during pregnancy: since a woman initiating treatment during pregnancy will only become eligible to enter a differentiated ART delivery model in the postpartum period, an HIV-negative result for her infant with a NAT at six weeks and evidence of accessing infant follow-up care are additional requirements.
Children

Successful treatment of children, especially younger children, requires that caregivers understand the importance of adherence and retention in care. Several factors affect adherence and retention in care, including appropriate ARV drug formulations, centralized paediatric care, adequate psychosocial support and effectively disclosing HIV status to children.

WHO recommends age-appropriate disclosure to children (159). Other solutions include: supporting caregivers to attend for regular follow-up by providing adherence counselling and appointment reminders; psychosocial support to address issues of stigma and fear; assisted disclosure – caregiver buddy support on the disclosure process and reinforcing to caregivers the importance of disclosing to the child, which can begin early with age-appropriate messaging and tools.

Adolescents

Frequent clinic visits, fear of stigma, time spent waiting for services and having to miss school discourages adolescents’ engagement in care and may lead to poor adherence and disengagement from care (120,160). Negative attitudes of health-care workers, concerns about privacy and confidentiality and limited opportunity to discuss their concerns also act as barriers to retention for young people. Distance to facilities and out-of-pocket expenses may restrict engagement. Service delivery models beyond the facility that support adolescents in engaging in care, such as peer-based interventions and community-based services, should be considered. Young people value peer interventions highly. Adolescent-friendly health services should be implemented to improve quality (see section 7.11).

Consider:

  • providing adolescent services at specific times or in separate areas with flexible appointment systems that accommodate school hours;
  • providing comprehensive services that address multiple needs, including psychosocial support and sexual and reproductive health; and
  • closely monitoring adolescents’ engagement in care, rapidly and proactively following up and implementing strategies for re-engagement.

Men

A systematic review of 31 studies found that men had a 46% increased hazard of death while receiving ART compared with women (11). This is partly explained by the fact that men tend to be diagnosed later and are more likely to start ART late. Men in settings with a high burden of HIV infection and men from key populations are consistently less likely to know their HIV status than women. In 2021, WHO issued a policy brief highlighting the need to improve coverage of HIV testing among men. This policy brief emphasizes that, in settings with a high burden of HIV infection, efforts are needed to test more men in both general and key populations. In settings with a low burden of HIV infection, HIV testing services should give priority to men from key populations; men with sexually transmitted infections; men with confirmed or suspected TB; men whose partners have HIV; and men who have HIV-related symptoms or indicator conditions (161).

In several settings, initiatives to improve men’s engagement in care have focused on engaging them in services for preventing mother-to-child transmission. Innovative service delivery models are essential to improve men’s access to HIV care services and ART initiation. Programmes need to routinely disaggregate data by sex to better monitor access to and outcomes of treatment for both men and women.

Key populations

Specific consideration, especially in settings in which people are criminalized because of their behaviour or identity, requires delivery community and peer-based options to support people to retain care.

People in prison and other closed settings

Implementing safety measures to assure the continuity of care is critical, such as providing two months of ART to people who move back into the community to address issues such as housing, health insurance and health-care provider.

Implementation considerations

No single model of community or peer support works in all settings, and programmes need to adapt such interventions to the local context. Some clients may choose not to receive services in the community because of concern about stigma and discrimination. Community interventions require linkage with health facilities for smooth transfer and referral, when necessary, and strategic planning and resourcing for sustainability. Community-level programmes still need to be integrated into national health sector plans in many settings.

Research gaps

Implementation research and evaluation of the different models of community-level support in different contexts are necessary to further guide programmes. Effective strategies are needed to support transitioning across care-delivery points for men, postpartum women, adolescents and children. Further data on the cost of implementing community-level interventions in different settings will guide national policy.

7.6.2. Tracing and re-engagement in care

Recommendation (2021)

HIV programmes should implement interventions to trace people who have disengaged from care and provide support for re-engagement (strong recommendation, low-certainty evidence).

Source: Updated recommendations on service delivery for the treatment and care of people living with HIV (63)

Background and rationale

WHO guidelines strongly recommend that programmes provide community support for people living with HIV to improve retention in HIV care (3). Poor retention undermines positive programme outcomes, including reducing mortality and achieving sustained population suppression of viral loads. Although many programmes have adopted these recommendations to support retention, loss to follow-up remains substantial in all regions, and especially in southern Africa, affecting all age groups (4,143,144). Although some individuals who are no longer engaged in care for various reasons have died, recent data suggest that many individuals who are successfully traced are alive (161), and many are willing to re-engage in care. WHO recommends patient tracing as one of many potential interventions that could improve linkage between diagnosis and ART initiation (3).

A systematic review assessed activities to trace individuals who have disengaged in care and to identify interventions to support re-engagement in care; the review identified 37 studies, eight of which included children and adolescents (163). Overall, among those who were alive, 58% (95% CI 51–65%) re-engaged in care. Tracing and re-engagement action appeared to be more successful when people were traced soon after a missed visit compared with a longer period of disengagement. Approaches to tracing included remote communication (phone, text messages, mail and email), in-person tracing and a combination of both approaches.

Benefits and harm

Tracing activities can successfully re-engage people in care and achieve resuppression of viral loads. The certainty of the evidence was judged to be low, mainly because of important heterogeneity in outcomes across studies leading to imprecise estimates of benefit. The literature did not identify any important harm. Although tracing activities carry the hypothetical risk of inadvertently disclosing HIV status that could lead to intimate partner violence, discrimination and stigma, this risk is considered small and is outweighed by the benefits of re-engaging individuals into care and onto life-saving ART, without which there would be increased illness and death. The Guideline Development Group made a strong recommendation despite low-certainty evidence given the confidence in the health benefit for people returning to care and minimal harm associated with tracing and re-engagement activities.

Feasibility, cost and cost–effectiveness

Most reports described the tracing activities undertaken by existing health facility personnel; in some cases, social workers and community health workers formed part of the tracing team, and personnel were trained. Other associated costs include establishing systems to trace and support re-engagement. In-person tracing requires resources to support the travel of tracing teams and human resources with appropriate training and remuneration, including the potential need to undertake multiple tracing attempts.

Equity and acceptability

Tracing in the absence of consent may be considered intrusive and may not be accepted by people who have disengaged from care (with various motivations). Tracing must also be sensitive to the need to respect human rights and confidentiality and avoid inadvertently disclosing HIV status. The Guideline Development Group judged that the intervention would probably increase equity and is probably acceptable to most people living with HIV if delivered in a non-judgemental approach. Clients should be provided with the opportunity to consent to tracing when ART follow-up is discussed during counselling and at ART initiation.

Implementation considerations

Support for re-engagement in care can include interventions directed towards people living with HIV, such as peer or health-care provider outreach and navigation back to care as well as towards health-care providers and health facilities (through systems to alert health-care providers that people have disengaged). Interventions could include reminders (such as phone calls or text messages), economic interventions (such as financial incentives or conditional cash transfers), case management or policy interventions, with steps taken to ensure confidentiality. Programme- or facility-level confidential contact details should be kept up to date to ensure successful tracing if and when required. When considering tracing people who are not engaged in care, adequate assessment of the risks to vulnerable and key populations is critical. For example, women are subject to increased levels of both intimate partner and gender-based violence in the context of HIV, and appropriately training health-care providers is therefore essential (164). It is critical to understand both general and local reasons for failures of retention; these are far more predictive than sociodemographic factors such as age and sex (165).

The criteria for tracing and recall should consider those who are seven or more calendar days late for a scheduled appointment. Although efforts should be made to trace everyone who has missed appointments and/or has abnormal results, the following groups should be given priority: (1) people initiating treatment in the past six months with advanced HIV disease, (2) people with abnormal results, (3) people not initiating treatment and (4) people overdue for clinical consultations or laboratory tests.

A non-judgemental approach is essential to supporting people in returning to care; this requires reducing system barriers and improving interpersonal communication by developing the capacity of health-care providers. The Welcome Back service established by Médecins Sans Frontières and the Department of Health of South Africa provides a strong example of such an approach combining medical and psychosocial support for people who have disengaged from care (162,166).

Research gaps

Several studies have described the most common reasons for disengaging from care either before or after initiating ART (74,165,167,168). Research is needed to tailor support that responds to these drivers to minimize disengagement and support re-engagement at different stages along the continuum of care. Qualitative research is important to understand the most acceptable and effective methods of tracing and re-engagement. In addition, this research should include disaggregated approaches based on the population group (such as key populations), gender and age.

7.7. Task sharing

7.7.1. Task sharing for initiating and maintaining ART

Recommendation (2016)

The following recommendations apply to all adults, adolescents and children living with HIV.

  • Trained non-physician clinicians, midwives and nurses can initiate first-line ART (strong recommendation, moderate-certainty evidence).
  • Trained non-physician clinicians, midwives and nurses can maintain ART (strong recommendation, moderate-certainty evidence).
  • Trained and supervised community health workers can dispense ART between regular clinical visits (strong recommendation, moderate-certainty evidence).
  • Trained and supervised lay health-care providers can distribute ART (strong recommendation, low-certainty evidence).

Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach – second edition (3)

Background

The number of available health-care providers remains inadequate in many settings with a high burden of HIV. Task sharing involves redistributing tasks within health workforce teams. Specific tasks are reassigned to health-care workers with shorter training and fewer qualifications to optimize the available human resources. Although increasing the number of health-care personnel is also crucial, clinical tasks need to be shared to ensure that enough health-care workers are available.

Since 2013, WHO has made a series of recommendations on task sharing relating to initiating and maintaining ART for adults, adolescents and children. These recommendations are supported by randomized trials and observational studies (169171). Overall, the evidence shows comparable clinical outcomes and reduced rates of loss to follow-up when nurses or non-physician clinicians initiate or maintain people on ART or when community health workers maintain people on ART, relative to physicians performing these tasks. Quality of care is ensured by providing training, mentoring and supervision for nurses, non-physician clinicians and community health workers, clear referral pathways and effective monitoring and evaluation systems.

In 2016, WHO further recommended that trained community health workers be able to dispense and distribute ART. A meta-analysis of findings from two cluster-randomized trials comparing dispensing ARV drugs between pharmacists and non-pharmacists found comparable clinical outcomes and improved retention comparing people who received care from a community-based team and those who received care from health-care professionals at a health facility (59,170,172). The evidence was rated as low certainty because of indirectness, since the lay health-care providers were part of a wider community-based intervention with additional elements that supported the success of the intervention. Nevertheless, the Guideline Development Group strongly recommended that trained and supervised lay health-care providers be able to distribute ART to adults, adolescents and children living with HIV, citing existing programme experience of trained and supervised community health workers and lay health-care workers providing HIV testing, care and treatment services. In addition, the Guideline Development Group cited important examples within the broader health sector in which community health workers, with minimal training, are entrusted to provide curative and preventive care in maternal, newborn and child health services, malaria diagnosis and treatment and TB care.

Benefits and harm

The public health benefits of lay health-care providers distributing ARV drugs are increasing the overall number of providers to overcome shortages of facility personnel, reducing facility congestion and providing services closer to communities that support retention in care. If ARV drug supply and stock management are not reliable, lay personnel distributing ARV drugs outside health facilities may increase distribution sites and potentially aggravate stock-out. Neither of the two studies included people with comorbidities or children. The Guideline Development Group advised that the dose for growing children can be safely adjusted during clinic visits with maintenance treatment at the community level.

Cost and cost–effectiveness

Costs for training and other costs associated with introducing community ART distribution may be initially increased. However, studies report substantial user costs when they are required to travel to centralized health services to collect medication. A study from Uganda reported that the cost to beneficiaries receiving hospital-based care was three times higher than for people who received home-based care (172).

Equity and acceptability

A qualitative evidence synthesis found that task sharing can enhance linkage to care and treatment adherence and helped HIV programmes cope with shortages of professional health-care workers (15). Strengthened relationships between people living with HIV and local communities can empower individuals. In Malawi, people from the community were hired as pharmacy attendants to pre-package and distribute ARV drugs to enhance the capacity of pharmaceutical services, an approach that has facilitated visit spacing and reduced waiting times and health-care providers workload at health facilities (173). All providers should be sensitized to the specific needs of the various people living with HIV groups, including key populations.

Implementation considerations

Initial and ongoing training and mentoring, supportive supervision and administrative planning have been critical to the success of programmes that have implemented task sharing. Programmes adopting these recommendations need to train and establish a system for routine supportive supervision of health-care workers, including lay health-care providers. Adopting task-sharing strategies often requires revising regulatory frameworks and national policies so that new cadres of health-care workers can perform new tasks. WHO recommends that all health-care workers, including community health workers, should be appropriately trained, remunerated and supervised (174), and programme experience indicates that sustaining health services based on volunteerism alone is difficult. National regulatory bodies, professional associations and other stakeholders need to be involved in addressing the scope of practice, roles and responsibilities of health-care workers. Relevant curricula for training the various community cadres must be in place.

The local supply chain system must consider task-sharing responsibilities and community models of ARV drug delivery to ensure adequate stock. The supply management logistic information system needs to incorporate all ARV drug distribution outlets, including community and lay health-care providers’ distribution sites (see section 6.13).

7.7.2. Task sharing of specimen collection and point-of-care testing

Recommendation (2021)

Task sharing of specimen collection and point-of-care testing with non-laboratory personnel should be implemented when professional staffing capacity is limited (strong recommendation, moderate-certainty evidence).

Source: Updated recommendations on service delivery for the treatment and care of people living with HIV (63)

Background and rationale

The 2016 WHO consolidated HIV treatment guidelines (3) stated that good practice includes trained and supervised non-laboratory personnel, including lay people, being able to collect blood samples through finger-pricks. This statement was made at a time when data comparing the performance of specimen collection and/or testing by non-laboratory personnel versus laboratory professionals were limited. Most data before the 2016 consolidated HIV treatment guidelines focused on point-of-care diagnostic accuracy studies conducted in the laboratory by laboratory professionals.

Since 2016, several additional studies have been published, including the diagnostic accuracy of decentralized and task-shared specimen collection and/or testing with non-laboratory professionals (175). In addition, clinical studies examining how point-of-care testing by non-laboratory personnel affects the people being tested have been published (176). Together, this updated evidence has supported consideration of using point-of-care infant diagnosis and viral load testing to improve health outcomes.

In several settings, trained and supervised lay health-care providers are already conducting HIV testing and collecting blood samples through finger-pricks. In 2015, WHO strongly recommended that lay health-care providers who are trained and supervised be able to independently conduct safe and effective HIV testing using rapid diagnostic tests (177).

Access to diagnostic testing and sample collection remains low in many resource-limited settings, partly because of shortages of human resources, especially in rural settings. The lack of skilled laboratory professionals at health-care facilities and the need to scale up capacity may require sharing the tasks of point-of-care diagnostic testing and sample collection with lower cadres of health-care workers. Task sharing may also increase access to testing for key populations, who may have difficulty in accessing traditional health-care services regardless of professional staffing capacity.

A systematic review identified 65 studies, mainly diagnostic accuracy studies (175). Three randomized controlled trials assessed the clinical impact of point-of-care testing. Most studies (86%) were carried out in Africa. The certainty of the evidence was rated as moderate. Ten types of non-laboratory health-care workers performed nine types of point-of-care tests using 13 assays. Most studies included nurses. The primary outcome observed across most studies focused on the diagnostic accuracy of point-of-care testing performed by non-laboratory personnel (175).

Diagnostic accuracy of point-of-care CD4 count

Compared with laboratory-based testing performed by laboratory professionals, point-of-care CD4 count testing performed by non-laboratory health-care personnel had a mean bias of –35.72 cells/mm3 (95% CI –57.10 to –14.33) (175). Four studies compared the performance of point-of-care CD4 testing between laboratory professionals and non-laboratory personnel. The performance of each study was within the ±50 cells/mm3 range, and the overall mean bias was –13.35 cells/mm3 (95% CI –19.97 to –6.72). One study reviewed the performance of a device-free lateral flow CD4 assay when performed by nurses compared with laboratory-based CD4 testing performed by laboratory personnel (178) and found better performance of the test on venous blood (sensitivity = 81.7%; 95% CI 72.3–91.1%; specificity = 82.6%, 95% CI 77.1–88.1%) than on finger-prick specimens (sensitivity = 60.7%; 95% CI 45.0–76.3%; specificity = 89.5%, 95% CI 83.2–95.8%). No statistically significant difference in performance was detected by cadre of health-care worker (P = 0.11) or between point-of-care versus laboratory-based testing (P = 0.11).

Diagnostic accuracy and clinical impact of point-of-care infant diagnosis

A systematic review provided summary estimates of the diagnostic accuracy of technologies capable of being used at the point of care (179). The performance overall was >98% sensitivity and >99% specificity. Seven of the 11 studies conducted the point-of-care test outside the laboratory. One study compared internal quality control rates and the return of results to caregivers for samples run on a point-of-care infant testing technology between nurses and laboratory-trained personnel to assess how task sharing affects the quality of testing. Failure rates did not differ significantly between non-laboratory testers (137 of 14 830 tests) and specialized laboratory-trained testers (28 of 364 tests) (P = 0.35) (180).

Point-of-care same-day testing significantly reduced the time to deliver test results to caregivers (176). In all seven studies (176), the median time between sample collection and the results received by the infants’ caregivers was 0 days (95% CI 0–0 days) for point of care, regardless of the test used, the age of the infant or the type of health-care facility. Same-day results were returned 97% of the time for point-of-care testing versus 0% for standard care. For laboratory-based testing, the median time between sample collection and results received by the caregiver ranged from 8 to 125 days, with a median of 35 days (95% CI 35–37 days). Five of seven studies had a median time to the caregiver receiving results exceeding 30 days.

The overall proportion of infants living with HIV initiating treatment within 60 days was 90% using point-of-care testing versus 54% using laboratory-based testing. The odds ratio of initiating treatment within 60 days was 7.9 (95% CI 5.4–11.5).

Three studies reviewed the performance of cryptococcal antigen lateral flow assays when used by non-laboratory personnel (181183). The non-laboratory personnel correctly identified cryptococcal antigen with 100% sensitivity and specificity in two of the studies. In the third study, when tested on serum samples, cryptococcal antigen lateral flow assays had sensitivity of 93% (95% CI 66–100%) and specificity of 100% (95% CI 88–100%). Two independent readers strongly agreed on the interpretation of results (P < 0.001). When trained nurses performed cryptococcal antigen lateral flow assays at the point of care, testing was feasible, had the highest accuracy on serum specimens and may accelerate the prophylaxis and treatment of HIV-associated cryptococcal infections.

In addition, syphilis testing by non-laboratory personnel using the dual HIV and syphilis rapid diagnostic test had agreement of 0.67 (95% CI 0.36–0.97) and specificity of 99.9% (95% CI 99.8–100%) versus laboratory technicians (184). Nursing personnel successfully tested external quality assurance panels using syphilis rapid tests, with sensitivity and specificity exceeding 90%.

Three studies compared the performance of alanine aminotransferase and haemoglobin enumeration tests operated by non-laboratory personnel with laboratory-based technologies operated by laboratory professionals (185187). Non-laboratory personnel operated both tests comparably to the laboratory-based technologies operated by laboratory professionals. A semiquantitative, visual point-of-care alanine aminotransferase assay performed by nurses had sensitivity of 87% and specificity of 77% compared with a laboratory-based technology operated by laboratory professionals. One study reviewed the performance of creatinine and lactate testing by non-laboratory personnel at two separate clinics. Creatinine testing had mean bias values of –4.5 µmol/L (95% CI –2.09 to –6.42 µmol/L) and –5.5 µmol/L (95% CI –4.49 to –6.42 µmol/L), and lactate testing had mean bias values of 0.01 mmol/L (95% CI –0.10 to 0.13 mmol/L) and 1.1 mmol/L (95% CI 1.04–1.18 mmol/L).

Clinical impact of point-of-care viral load testing

Using point-of-care tests, same-day viral load results were available to clinicians 99% of the time (median time to results being returned: 0 days) and to patients 99% of the time (median: 0 days) (188,189). Using standard care laboratory-based testing, same-day results were available for clinicians <25% of the time (median: 2 days) and for patients <1% of the time (median: 28 days). The observational studies also demonstrated substantially shorter time to return of results to both clinicians and patients using point-of-care testing versus laboratory-based testing. The hazard ratio comparing point-of-care with laboratory-based testing was 11.7 (95% CI 8.9–15.3) for returning the results to clinicians and 17.7 (95% CI 13.0–24.1) for returning the results to patients.

In the randomized controlled trial, 100% of the people identified with non-suppressed viral loads initiated second-line ART following point-of-care testing (median: 0 days) versus 44% (median: 76 days) following laboratory-based testing (risk difference = 56 percentage points, 95% CI 23–88 percentage points; hazard ratio = 11, 95% CI 2–58). The estimated time to any clinical action (either enhanced adherence counselling or initiating second-line ART) was also shorter following point-of-care testing versus laboratory-based testing in observational studies.

Benefits and harm

The Guideline Development Group formulated a strong recommendation based on judgement of the overwhelming benefits of the intervention, including, but not limited to, the following.

  • Most settings with limited resources and a high burden of HIV infection lack laboratory professionals.
  • Decentralized and task-shared specimen collection expands access to testing (dried blood spot specimens for infant diagnosis and viral load).
  • Point-of-care testing leads to more rapid testing, return of results to clinicians and patients and clinical action.
  • Fewer health facility visits are needed for caregivers to receive results, and the timing of results is more reliable.

There was no major harm, but more extensive network support and maintenance were needed.

Feasibility, cost and cost–effectiveness

Overall, task sharing of specimen collection and point-of-care testing with non-laboratory personnel was feasible and acceptable. Task sharing would save costs with deployment of personnel with less training for diagnostic testing and sample collection. The most important cost will be training, ongoing supervision and remunerating non-laboratory personnel, albeit at a potentially lower cost compared with laboratory professionals. Decentralization will likely result in increased proportions of non-laboratory personnel required to perform the specimen collection and testing, requiring careful assessment and expansion of human resource capacity.

Equity and acceptability

Task sharing of specimen collection and point-of-care testing with non-laboratory personnel is likely to improve equity, since relying on specialized personnel favours populations in urban settings and increases the transport burden on rural populations, which generally have the lowest incomes. Task sharing may also increase access to testing for members of key populations, who may have difficulty in accessing traditional health services and facility-based services. Further, decentralizing specimen collection and testing, including at community-based sites, may increase access to diagnostics, especially including interventions and technologies capable of returning the results on the same day or more rapidly than laboratory-based testing.

In a systematic review, 58% of non-laboratory personnel indicated that preparing dried blood spot specimens for viral load was very easy, 43% indicated that collecting specimens was easy and 85% indicated that preparing dried blood spots was suitable for nonlaboratory personnel (175). Nurses had a 98% success rate of finger-prick blood specimen collection in South Africa. One study reported an ease-of-use score for task sharing point-of-care CD4 testing between 1.7 and 3 on a scale of 1 to 5 (5 being very difficult), and health-care worker trust in the test was measured at 82–100%. Another study found an odds ratio of 1.9 (95% CI 1.1–3.3) for more rational use of higher-level clinical personnel time when point-of-care CD4 testing operated by lower-level personnel was introduced instead. Further, 95% (95% CI 93–96%) of lay health-care workers rated the point-of-care CD4 technology favourably. All non-laboratory personnel found the point-of-care viral load testing to be easy or very easy to use, and 85% of the respondents indicated that point-of-care viral load testing was suitable or very suitable for non-laboratory personnel. Ninety per cent of non-laboratory personnel said that a syphilis rapid diagnostic test was easy to use, and antenatal care personnel scored the dual HIV and syphilis rapid diagnostic test 2.41 (with 3 being easiest) for ease of use and 2.27 (of 3) for ease of interpretation.

A study in Cameroon, Côte d’Ivoire, Eswatini, Kenya, Lesotho, Mozambique, Rwanda and Zimbabwe conducted structured interviews with health-care workers providing infant testing services and semistructured interviews with national and regional laboratory managers or early infant diagnosis programme managers before and after point-of-care infant testing was implemented (188). Health-care workers found point-of-care infant testing easy to use (74% said it was very simple to run the test), and 93% were very satisfied with the rapid turnaround time and ability to initiate treatment for infants living with HIV sooner.

Implementation considerations

Access to high-quality diagnostic testing should be continually expanded across HIV and other molecular testing needs, ideally combining laboratory-based and point-of-care technologies in an integrated laboratory network. Implementing a wide network of decentralized specimen collection and/or point-of-care testing requires centralized support from national laboratories and programmes to ensure adequate training, mentorship, service and maintenance, continuous quality assurance and accurate data entry at the point of care. In addition, decentralizing specimen collection and task sharing requires expanding human resource capacity. Legal and regulatory issues and policies may need to be adjusted in some countries to support the decentralization and task sharing of specimen collection and testing with non-laboratory personnel. Concurrently, scaling up and building human resource capacity, including strengthening laboratory personnel and capacity, will be critical to expanding diagnostic access. WHO has developed tools and guidelines for human resources for health and recommends an approach to systematically address the dynamics of the health workforce that includes assessing workload indicators among health-care providers.

Research gaps

Additional diagnostic accuracy studies directly comparing the performance of newer point-of-care technologies (infant diagnosis and viral load testing) between non-laboratory personnel and laboratory professionals would be valuable.

7.8. Decentralization

Recommendation (2013)

Decentralization of ART care should be considered as a way to increase access and improve retention in care. The following approaches have demonstrated effectiveness in improving access and retention:

  • initiating ART in hospitals, with maintenance of ART in peripheral health facilities (strong recommendation, low-certainty evidence);
  • initiating and maintaining ART in peripheral health facilities (strong recommendation, low-certainty evidence); and
  • initiating ART at peripheral health facilities, with maintenance at the community level (strong recommendation, moderate-certainty evidence).a

Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: summary of key features and recommendations, June 2013 (190)

a

The community level includes external outreach sites, health posts, home-based services or community-based organizations. The frequency of clinic visits depends on health status.

Background

The rapid scale-up of ART programmes has posed significant challenges to health systems in settings with a high burden of HIV infection and limited resources. Many clinics have long waiting times because of the volume of people needing care. Decentralizing HIV care and treatment has been shown to reduce waiting times and bring HIV services closer to people’s homes. It can also strengthen community engagement by linking community-based interventions with health facilities and optimize access to services, care-seeking behaviour and retention in care (191194).

Rationale and supporting evidence

A systematic review identified 16 studies providing evidence that decentralizing ART care, either from hospitals to health centres or from health centres to community-based care, reduces attrition without compromising clinical outcomes. All but one of the studies were carried out in sub-Saharan Africa, and the benefits of decentralization may differ by setting (192).

Implementation considerations

The optimal model for ART decentralization (partial or full) depends on the local context, including the burden of HIV infection and the health-care delivery systems. Programmes should determine which clinical and laboratory services will be available at what level of the health-care delivery system.

Programme managers should consider the attitudes and preferences of those receiving care, the number of people likely to attend decentralized settings and whether decentralization brings services closer to people who would otherwise travel long distances to receive ART.

Decentralization should be accompanied by efforts to strengthen linkage and referral systems. Community-based treatment programmes should be linked with care at health facilities and with adequate laboratory, diagnostics, monitoring and evaluation and drug and supply management systems.

Standards of care should be defined for each level of the health system, including the private sector. The role of each level should match its capacity, and the lines of authority and accountability should be clear and well understood. In many settings, decentralizing ART requires task sharing to ensure an appropriate mix of health-care workers at peripheral facilities. An appropriate regulatory framework (laws, regulations, policies and guidelines) is needed to enable tasks to be performed by different cadres of health-care workers.

Adaptations may be needed for specific populations. HIV care and treatment services for pregnant and postpartum women and HIV-exposed and infected children can be provided in decentralized settings. This is a preferred option if the burden of HIV infection is high and many women and children access health services in primary care settings. In settings with a low burden of HIV infection, a centralized service delivery model with community linkage may be more appropriate. Some groups, such as adolescents and key populations, may choose to receive HIV services in a facility that is not close to their homes because of stigma and disclosure-related concerns. In such settings, health-care providers should incorporate the values and preferences of adolescents and key populations in designing appropriate service delivery models.

7.9. Integrating services

Chronic care requires integrating and linking related services to ensure that comprehensive and consistent care is provided over time, including providing related services in the same settings, systems to share information and effective referrals across settings and providers. Integrating and linking services are likely to reduce missed opportunities for initiating ART, enhance adherence support and optimize retention in care.

7.9.1. Delivering ART in maternal and child health-care settings

Recommendation (2013)

In generalized epidemic settings, ART should be initiated and maintained in pregnant and postpartum women and in infants at maternal and child health-care settings, with linkage and referral to ongoing HIV care and ART, if appropriate (strong recommendation, very-low-certainty evidence).

Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: summary of key features and recommendations, June 2013 (190)

Background

Since 2016, WHO has recommended initiating ART to everyone living with HIV regardless of CD4 cell count, including pregnant and breastfeeding women. However, access to ART for pregnant and breastfeeding women living with HIV remains a challenge, as does providing essential HIV services to HIV-exposed uninfected and infected infants and ensuring that services for preventing mother-to-child transmission reach pregnant adolescent girls and young women, female sex workers and women who inject drugs.

Because many women living with HIV only access health services at the time of pregnancy, maternal and child health settings provide a key opportunity to provide access to ART (195,196). In most generalized HIV epidemic settings, maternal and child health services are provided at the primary care level, where pregnant women and children predominantly access health services. WHO recommends offering HIV testing services to pregnant women through provider-initiated approaches as an essential component of maternal, newborn and child health services. WHO also recommends couple and partner HIV testing for all pregnant women and their partners in maternal and child health-care services in generalized HIV epidemics and that such testing be considered for key populations in concentrated and low-level epidemics (9). In addition, in settings with a high burden of HIV infection, retesting is advised for all pregnant women with an unknown or HIV-negative status during late pregnancy (third trimester). Catch-up testing is needed if the first test or retest is missed or delayed. Countries with a high burden of HIV infection could consider an additional retest in the postpartum period for specific districts or regions with high HIV burden or incidence, women from key populations and women who have a partner living with HIV who does not have suppressed viral loads (9).

ART should be available in maternal and child health clinics or easily accessible in a linked model of service delivery. Countries with generalized epidemics may consider a phased approach to providing ART in maternal and child health settings, which may effectively transform such settings into ART sites, giving priority to facilities with the largest burden of HIV and building health systems to ensure uninterrupted ART, good adherence and retention to maintain viral suppression. All pregnant women, regardless of when they start ART, may require more intense monitoring of viral suppression, including conducting viral load testing at 34–36 weeks of gestation (or at the latest at delivery) to identify women who may be at risk of treatment failure and/or may deliver infants at higher risk of perinatal transmission. In addition, a viral load test is recommended for all breastfeeding women three months after delivery and every six months thereafter to detect viraemic episodes during the postnatal period (197).

Not all maternal and child health settings will have capacity to provide long-term HIV care and treatment for women, their partners and infants. These settings will need to assess and decide on the best time for transitioning and linking mothers and their infants to chronic HIV care and from chronic care into maternal and child health settings when the pregnant woman was already receiving ART at the time of conception. Providing choice for where a woman living with HIV receives ART care remains important and should not interfere with efficient provision of quality and person-centred antenatal care. Issues to consider in the assessment may include the capacity and quality of HIV care in the maternal and child health-care setting, acceptability and proximity of alternative HIV care settings and the burden of HIV infection.

Rationale and supporting evidence

A systematic review found one cluster-randomized trial and three observational studies which showed that integrated services improved uptake of ART and adherence to ART during pregnancy; outcomes for maternal mortality, morbidity, immune response, infant HIV testing uptake and mother-to-child transmission were comparable (198203). Health-care providers thought that integrated services increased efficiency, decreased waiting time for clients and improved relationships between providers and patients, resulting in less stigmatization and improved adherence to treatment and care (204).

7.9.2. Delivering ART in TB treatment settings and TB treatment in HIV care settings

Recommendation (2013)

In settings with a high burden of HIV and TB, ART should be initiated in TB treatment settings, with linkage to ongoing HIV care and ART (strong recommendation, very-low-certainty evidence).

In settings with a high burden of HIV and TB, TB treatment may be provided for people living with HIV in HIV care settings if they have also been diagnosed with TB (strong recommendation, very-low-certainty evidence).

Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: summary of key features and recommendations, June 2013 (190)

Background

The percentage of notified people with TB who had a documented HIV test result in 2019 was 69%, up from 64% in 2018. In the WHO African Region, the WHO region with the highest burden of HIV-associated TB, 86% of people with TB had a documented HIV test result. A total of 456 426 people coinfected with TB and HIV were reported, of whom 88% were receiving ART (205).

Since 2010, WHO has recommended ART for everyone with TB who is living with HIV, regardless of CD4 cell count. In 2021, WHO recommended that ART be initiated as soon as possible and within two weeks after starting TB treatment. Co-trimoxazole prophylaxis is also recommended for all people with both TB and HIV. TB infection control measures are crucial in HIV care settings to minimize the risk of nosocomial transmission of TB.

Rationale and supporting evidence

A systematic review evaluating the effectiveness of delivering ART in TB treatment settings identified 19 observational studies, many of which showed increased uptake and timeliness of ART initiation. However, the data on mortality and TB treatment success were inconsistent. The same systematic review identified five observational studies evaluating the effectiveness of delivering TB treatment in HIV care settings. Two studies reported decreased mortality and another showed comparable mortality rates. The TB treatment success rates and ART uptake were comparable across studies (206).

7.9.3. Integrating sexual and reproductive health services, including contraception, within HIV services

Recommendation (2016)

Sexually transmitted infection and family planning services can be integrated within HIV care settings (conditional recommendation, very-low-certainty evidence).

Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach – second edition (3)

Recommendation (2021)

Sexual and reproductive health services, including contraception, may be integrated within HIV services (conditional recommendation, very-low-certainty evidence).

Source: Updated recommendations on service delivery for the treatment and care of people living with HIV (63)

Background and rationale

Among the 1.9 billion women of reproductive age (15–49 years old) worldwide in 2019, 1.1 billion need family planning and 270 million have an unmet need for contraception. Across WHO regions, evidence indicates that sex workers have a greater unmet need for contraception than the general population, and reports indicate excessive reliance on using condoms alone instead of the recommended dual protection (207210). The proportion of the need for sexual and reproductive health services, including contraception services, that was satisfied by modern methods was 76% globally in 2019, but this fell to less than 50% in western and central Africa. WHO emphasizes the importance of linking sexual and reproductive health and rights and HIV for adolescent girls and young women (211). Since women living with HIV face unique challenges and human rights violations related to their sexuality and reproduction within their families and communities and from the health-care institutions from which they seek care, creating an enabling environment is especially emphasized to support more effective health interventions and better health outcomes (212).

In 2016, WHO conditionally recommended that sexually transmitted infection and family planning services be integrated within HIV care settings (3). Since that time, additional evidence has been published supporting the integration of sexual and reproductive health and HIV. A systematic review published in 2019 that considered linkage and integration found that the proportion of women receiving an HIV test during the study period ranged from 35% to 99% for integrated services and from 20% to 95% for non-integrated services or services integrated at a lower level (213,214); the review summarized findings from several studies that included adolescent girls and young women. The proportion of women accessing HIV services using contraception ranged from 54% to 80% for integrated services and from 10% to 83% for non-integrated services or services integrated at a lower level (213,214). Integrating HIV testing services with sexual and reproductive health services is feasible and has potential for positive joint outcomes. The review included six studies – one cluster-randomized trial carried out in Uganda and five non-randomized cluster trials carried out in Kenya, eSwatini and the United States of America. Two studies found that integration favoured an increase in sexual and reproductive health services, including contraception; one study found an increase in the uptake of dual contraceptive methods. In the study that reported dual method use, the proportion of women using dual methods during the study period was 34% for integrated services and 0% for non-integrated services (215). The overall certainty of evidence for all outcomes was very low, and the available evidence is limited (214). In the other direction, another systematic review of 14 studies found that integrating family planning into HIV care and treatment settings was associated with higher levels of use and knowledge of modern methods of contraception among women living with HIV (216).

Benefits and harm

Overall, integration is associated with increased offers and uptake of sexual and reproductive health services, including contraception, which is likely to result in improved downstream clinical outcomes. Given the nature of the intervention, the Guideline Development Group considered that the benefits likely outweighed any possible harm. One fear of integration is that tasking providers with too many services may reduce the quality of these services. However, it has been reported that integration can positively affect service quality and client outcomes for contraceptive use, ART in pregnancy and HIV testing (217). Integrating HIV and sexual and reproductive health services has been found to improve accessibility, the quality of antenatal care and nurse productivity while reducing stigma and without compromising the uptake of care (218).

Feasibility, cost and cost–effectiveness

A study from Zambia found that integrated HIV testing and counselling and voluntary male medical circumcision services could be provided at a lower cost per client than segmented, vertical provision (219). A study from Kenya (220) found decreased consultation times when services were integrated (10 versus 30 minutes); another study from Kenya (221) highlighted the need for sustained systems and health-care worker support over time. Integration may lead to increases in service efficiency, but this is likely to be highly context dependent (222224).

Equity and acceptability

A survey conducted among health-care providers and clients found that more than 90% of respondents considered that integration is important and feasible. Integration may improve access to sexual and reproductive health services, including contraception, among key populations. A study from Kenya found that access to sexual and reproductive health services, including contraception, for women who inject drugs can be improved by integrating contraceptive and other sexual and reproductive health interventions into existing outreach-based HIV prevention and harm-reduction programmes (225). Another study among female sex workers in Kenya found that integration improved access to the use of non-condom contraception methods, which is important for these people, who may have difficulty negotiating condom use (226). Integration also has the potential to reduce stigma. A survey of health-care providers in South Africa found that they considered integration important for reducing stigma and increasing access to and improving the quality of care (227).

Implementation considerations

Implementing comprehensive and integrated sexual and reproductive health and rights and HIV programmes to meet the health needs and rights of the diverse group of women living with HIV requires that interventions be put into place to overcome barriers to service uptake, use and continued engagement. In all epidemic contexts, these barriers occur at the individual, interpersonal, community and societal levels. They may include challenges such as social exclusion and marginalization, criminalization, stigma, gender-based violence and gender inequality. Strategies are needed across health system building blocks to improve the accessibility, acceptability, affordability, uptake, equitable coverage, quality, effectiveness and efficiency of services for women living with HIV. If left unaddressed, such barriers undermine health interventions and the sexual and reproductive health rights of women living with HIV (212).

Focusing on improving investment in the overall health system is important to support the integration of sexual and reproductive health services, including contraception and HIV services. Laws and policy barriers to accessing sexual and reproductive health services, including for adolescents, need to be addressed (212). Although this applies to any integration effort, it is especially important since sexual and reproductive health programmes have historically been implemented as established vertical programmes within health systems. WHO strongly recommends that care for women experiencing intimate partner violence and sexual assault be integrated as much as possible into existing health services rather than being a stand-alone service (212).

Training on human sexuality may facilitate greater understanding of sexually diverse communities, especially people identifying as lesbian, gay, bisexual, transgender, queer or intersex (LGBTQI) and adolescents and young people seeking accurate sexual and reproductive health and rights information and services (67).

Since an increasing proportion of people living with HIV are receiving their HIV treatment through a differentiated service delivery model with extended ART refills and less frequent clinical visits, aligning the provision of sexual and reproductive health services, including contraception (WHO recommends providing one year of oral contraception and supports community delivery and self-management) and commodities, with differentiated service delivery for HIV treatment models should be considered.

Careful planning and coordination are important for both programme management and service delivery, including establishing integrated data systems and providing consistent cross-training of health-care providers. Moreover, political will and significant coordination, collaboration and integration across disease programmes will be important (228,229).

Research gaps

The evidence supporting approaches to integrating sexual and reproductive health services, including a range of contraception, with HIV services is limited. Research is encouraged to identify approaches to integration that lead to better uptake of sexual and reproductive health services, including contraception; such research should also consider integrating cervical cancer screening and human papillomavirus vaccination. Implementation research is encouraged to evaluate different strategies of integration in different health systems and social contexts, including providing contraception in the context of less frequent clinical and ART refill visits. In addition, research into the efficiency of integrating antenatal and postnatal care and differentiated HIV services outside the maternal and child health service delivery may advise on differentiated service delivery. This in turn would support evidence on the best times for transitioning between maternal and child health services and chronic care.

7.9.4. Integrating diabetes and hypertension care with HIV care

Recommendation (2021)

Diabetes and hypertension care may be integrated with HIV services (conditional recommendation, very-low-certainty evidence).

Source: Updated recommendations on service delivery for the treatment and care of people living with HIV (63)

Background and rationale

Low- and middle-income countries are facing an increasing burden of noncommunicable diseases. Fifteen million people 30–69 years old die prematurely from noncommunicable diseases every year, and 85% of these people live in low- and middle-income countries. Diabetes and hypertension are the major cardiovascular risk factors for target organ damage of the brain, heart and kidneys. An estimated 425 million people in low- and middle-income countries currently have diabetes. This number is expected to increase to 629 million in 2045. The prevalence of hypertension in low- and middle-income countries is estimated to exceed 20% (230). Thanks to widespread access to ART, the life expectancy of people living with HIV has improved substantially, and this places them at risk of noncommunicable diseases that are common with increasing age. In addition to the elevated risks from modifiable factors for noncommunicable diseases such as smoking, poor diet and a sedentary lifestyle, people living with HIV have an independent increased risk of noncommunicable diseases (especially cardiovascular diseases, cervical cancer, depression and diabetes) related to HIV itself and to ART-related side effects (180,231).

In April 2019, WHO convened an expert scoping consultation on noncommunicable diseases and mental health conditions with policy-makers, academics and partners from the HIV, noncommunicable disease and mental health communities to review existing WHO norms and policies for preventing and managing major noncommunicable diseases and mental health conditions. Participants identified the need to establish effective approaches identifying for integrating hypertension, diabetes and HIV services (232).

A systematic review identified five studies – two interrupted time-series studies (233,234) and three cluster-randomized trials (235237) – and found that integrated models of care that include hypertension or diabetes or multi-disease approaches may increase the number of people controlling both blood pressure and HIV. It also found that offering integrated care was unlikely to alter mortality (RR 0.90, 95% CI 0.79–1.02). The overall certainty of evidence was very low, and the available evidence is limited (238).

Benefits and harm

The Guideline Development Group concluded that offering integrated services for managing hypertension and diabetes with HIV services will have a small benefit and that any possible harm is small and related to increased workload that may affect the quality of services.

Feasibility, cost and cost–effectiveness

The feasibility of integrating diabetes and hypertension care with HIV services may vary based on the setting and health system factors and should be supported at the planning and policy levels. Involving the community may promote increased uptake of diagnostic, preventive, treatment and referral services for HIV and noncommunicable diseases (239). One study found that engaging regulatory authorities early, considering work culture and building the capacity of a robust interdisciplinary workforce were critically important (240). A comparative study in sub-Saharan Africa concluded that multi-disease services can be offered at relatively low marginal cost (241).

Equity and acceptability

Implementing this recommendation may increase access to routine hypertension and diabetes services among those living with HIV with limited access to primary preventive services. The results of a WHO survey conducted to support these guidelines indicate that most respondents considered integrating HIV and diabetes (83%) or hypertension (78%) care to be very important or important. A systematic review reported high acceptability of integrated adherence clubs for people receiving chronic medication for controlling both HIV and noncommunicable diseases (242). Another review found that most people would accept receiving noncommunicable disease services in an HIV care setting. HIV care providers were willing to provide noncommunicable disease services and recognized the potential benefits of doing so but highlighted concerns around space constraints, increased workload, training requirements, supply chain shortages and potential effects on other services as key factors to consider (239).

Implementation considerations

Focusing on improving investment in the overall health system will be important to support the integration of hypertension, diabetes and HIV services. Since an increasing proportion of people living with HIV are receiving their HIV treatment through a differentiated service delivery model with extended ART refills and less frequent clinical visits, aligning the provision of noncommunicable disease commodities with differentiated service delivery for HIV treatment models should be considered.

Careful planning and coordination are important for both programme management and service delivery, including establishing integrated data systems and providing consistent cross-training of health-care providers. Moreover, ensuring political will and significant coordination, collaboration and integration across disease programmes will be important.

Research gaps

The following research gaps were identified: long-term data on the health outcomes of people living with HIV who have noncommunicable diseases, cost–effectiveness data for various models of integrated care and implementation research on optimizing the supply chain. Research can help to define health promotion activities that encourage lifestyle changes and protect against noncommunicable diseases among people living with HIV, who may face stigma and other challenges in receiving health promotion through the usual channels. Research is also needed to inform how hypertension and diabetes care can be integrated with the common differentiated models of service delivery implemented for HIV. Qualitative research can inform the values and preferences of people living with HIV and noncommunicable diseases related to how care is delivered.

7.9.5. ART in settings providing opioid substitution therapy

Recommendation (2013)

ART should be initiated and maintained in people living with HIV in care settings where opioid substitution therapy is provided (strong recommendation, very-low-certainty evidence).

Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: summary of key features and recommendations, June 2013 (190)

Background

These guidelines recommend the same ART eligibility criteria for all adults regardless of drug use behaviour. WHO recommends opioid substitution therapy (with methadone or buprenorphine) for treating opioid dependence combined with psychosocial support (243). Opioid substitution therapy should be integrated and administered in conjunction with ART for those who need it. Although some evidence suggests that opioid substitution therapy improves HIV treatment outcomes among people living with HIV who inject drugs, it should not be a prerequisite for initiating or maintaining ART.

Given the high incarceration rates of people who inject drugs, efforts should be made to ensure that ART is available as part of prison health services. Continuity of treatment and care need to be maintained through appropriate referrals when people return to the community.

Rationale and supporting evidence

A systematic review found one randomized trial and three observational studies evaluating the effect of delivering ART in settings providing opioid substitution therapy. Some studies observed trends of improved viral suppression and reduced mortality, whereas others found comparable rates of viral suppression and mortality (244246). A more recent systematic review provided additional support for the use of opioid substitution therapy, and its integration with HIV services, to improve the HIV treatment and care continuum among people who inject drugs living with HIV (247). A review of qualitative studies found that convenience and the comprehensive nature of co-located care support acceptability but that health system challenges need to be addressed to deliver integrated services (248).

This recommendation supports expansion of ART by delivering the service in settings providing opioid substitution therapy. Opioid substitution therapy should be provided free of charge or covered by public health-care insurance and should be accessible to everyone who needs it, including in prisons and other closed settings. HIV programmes need to continue to work closely with other service providers to ensure successful implementation of this recommendation. Guidance on maintaining effective opioid substitution therapy programmes is available in the WHO Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations (70).

7.9.6. Diagnostic integration

Good practice statement (2021)

Disease programmes, especially HIV and TB, should actively work towards balanced integration of diagnostic services.

Source: Updated recommendations on service delivery for the treatment and care of people living with HIV (63)

Background and rationale

The aim of universal health coverage and related services is to deliver high-quality people-centred integrated service and care. Universal health coverage also emphasizes a fundamental shift in service delivery such that services are integrated and focused on the needs of people and communities. One intervention that shows promise in helping to achieve these goals is diagnostic integration. Significant unmet testing needs remain across diseases, including HIV, TB and related infections. Programmatic integration (both sharing devices and integrating networks) is a priority intervention within the universal health coverage agenda to optimize the use of limited resources and improve care.

In 2017, WHO developed guidance for countries on the key considerations of multi-disease testing (249). In 2019, WHO held a country consultation to share experiences and focus on some of the aspects to diagnostic integration (250): funding and resources; optimizing and mapping the diagnostic networks; integrating systems; and considerations related to patients.

Several countries across WHO regions are already moving forward with diagnostic integration. Some countries are also sharing devices and considering integrating HIV and TB diagnostic services and incorporating hepatitis C virus, human papillomavirus and emerging outbreak infections. Several technologies exist that can conduct multiple tests on their technology and can be considered for diagnostic integration or device sharing (251).

Numerous country pilot projects are ongoing or completed, including from the Central African Republic, the Democratic Republic of the Congo, India, Malawi, Mozambique and Zimbabwe. During the 2019 consultation on diagnostic integration (250), countries reported the overall benefits diagnostic integration provides for all health programmes:

  • more efficient and comprehensive patient care pathways;
  • increased access for underserved or underfunded programmes;
  • a more optimized and collaborative integrated diagnostic network with improved laboratory workflow;
  • broader device footprints through shared technologies;
  • overall, more efficient laboratory services, including data management, sample transport, quality assurance, service and maintenance and supply chain;
  • increased negotiating power with suppliers because of increased volumes and a stronger voice for lower, more inclusive, transparent and fair prices across programmes, countries and regions and reduced costs and more efficient use of limited resources by sharing operational costs;
  • shared operational knowledge across programmes;
  • streamlined diagnostic capabilities and approaches across stakeholders; and
  • encouraging integrated cross-sectoral approaches to high-quality testing services and care.

Priorities may have to be set among patients and tests to consider the utilization needs of all programmes and to continue to ensure that the host programmes in particular have full access to device capacity. To ensure more rational integrated testing, several countries have continued testing all people with presumptive TB, with the addition of infant HIV diagnosis and targeted HIV viral load testing; HIV volumes were generally small and ensured no overutilization. Careful consideration for test volumes across diseases and how to set priorities among patients for point-of-care and laboratory referral testing will be critical through network optimization and mapping exercises.

The following challenges have been identified through pilots and programmes.

  • Focus is required to adjust the laboratory and clinic workflow on implementing additional assays on the integrated platform.
  • Systems considerations need to be implemented to ensure that results are returned on the same day, especially for more urgent tests and results, such as infant HIV diagnosis.
  • Adequate human resource capacity is needed to manage additional patient demand.
  • Service and maintenance contracts are often limited or challenging (this was specific to the technology implemented during pilot projects).
  • Significant support is necessary to ensure that adequate infrastructure is introduced.

Access to high-quality diagnostic testing should be continually expanded across testing needs, ideally combining laboratory-based and point-of-care technologies in an integrated diagnostic network without creating dependence on any one technology. Attention should also be paid to human resources, supply chain, quality assurance, monitoring and reporting and national regulatory components to develop sustainable and strong integrated networks. Careful planning and coordination are important for both programme management and service delivery. Moreover, ensuring political will and significant coordination, collaboration and integration across disease programmes will be important. Further, diagnostic integration and device sharing provide several potential mechanisms to reduce costs across assays, diseases and programmes (250).

Sharing costs between programmes could translate into cost savings for all programmes and more efficient use of resources. Costs can be shared between the host and beneficiary programmes under different allocation scenarios (such as by testing volumes, by allocating entire cost items to each respective programme or by accounting for already incurred investments). Costs are mainly saved by sharing device costs and service and maintenance costs (252). Leveraging existing device fleets with available capacity is a feasible approach to increase access to testing in a cost-effective manner. Tools exist to support countries in understanding the savings available and determining the most efficient and effective strategy.

A systematic review (253) found two observational studies reporting outcomes of integrating HIV and TB testing – one conducted by Médecins Sans Frontières in Zimbabwe (254) and another by the Clinton Health Access Initiative in Malawi and Zimbabwe (255). Both studies reviewed how integrating HIV testing with TB testing affected TB testing, the programme that procured and set up the technology.

Even with the addition of HIV infant testing and targeted HIV viral load testing, TB testing volume accounted for about 60% of the total after integration. Despite the increase in overall testing volumes, device use never exceeded 75%. Integration with HIV testing did not adversely affect the turnaround time for results or the outcomes. The time to return results and the proportion of people initiating TB treatment were the same before and after infant diagnosis testing and targeted viral load testing were added.

After integration with the TB-procured devices, HIV infant diagnosis and targeted HIV viral load testing experienced more rapid turnaround times and increased treatment initiation rates and increased probability of clinical action for infants living with HIV and people living with HIV receiving ART experiencing viraemia. Offering TB, HIV infant diagnosis and targeted HIV viral load through integrated testing increased device use without exceeding capacity or affecting TB services. Finally, these studies show that integrated testing was operationally feasible, with appropriate site selection to balance the expected demand. TB testing and treatment continued to be provided at the same rate.

Based on the available evidence and country experience, the Guideline Development Group determined that a good practice statement was indicated, since integrating diagnostic services across disease programmes is anticipated to result in a net overall benefit. The Guideline Development Group agreed that programmes should consider integrating their diagnostic services both for programmatic reasons and to ensure comprehensive care for people living with HIV. Increased efficiency is expected, and diagnostic integration and sharing of devices would enable more integrated health services and diagnostic networks.

Anticipated benefits include the potential to improve access to testing by increasing the device base; leveraging programmes’ knowledge; and shared operational costs. Diagnostic integration is also expected to create a more optimized, efficient network across diseases, improve patient care and reduce the costs generated in vertical programmes. Diagnostic integration is also expanded to ensure a more robust and reactive diagnostic network, especially positioned to respond to outbreaks and pandemics as they arise.

Knowledge gaps were identified that could benefit from further research, including measuring the impact of diagnostic integration across disease types (including HIV, TB, hepatitis, sexually transmitted infections, cervical cancer and disease outbreaks). Implementation research would be beneficial to generate best practices for diagnostic integration and quality assurance approaches for sustainable delivery of diagnostic integration.

7.10. Delivering HIV services to children

Background

Since 2016, WHO guidelines have recommended initiating ART for all children living with HIV regardless of CD4 cell count and clinical stage. However, gaps along the continuum of care translate into poor clinical outcomes for children living with HIV. Children with HIV are not being identified or are identified late, and even after diagnosis, linkage to care and ART, retention in care and viral suppression are low. The proportion of children lost to follow-up is estimated to be 9–14% during the first year of treatment and up to 28% during the second year of treatment (254). Predictors of attrition included younger age, shorter duration on ART and severe immunosuppression (7).

Several studies have described barriers to access to HIV services by children across the continuum of care. Some barriers are cross cutting, recurring at various stages along the continuum, some barriers are age specific and others are common to all age groups.

Box 7.5Barriers to treatment and care

HIV testing (257263)

Laboratory-related barriers include long turnaround time for early infant diagnosis and viral load monitoring results, ineffective transport of early infant diagnosis samples, delays in sample processing, reagent stock-outs, equipment maintenance issues and inadequate staffing. Other service delivery challenges include lack of skills in obtaining blood specimens from infants and other young children, lack of consensus on the legal age of consent for HIV testing and disclosure, health-care workers being unfamiliar with HIV testing and disclosure guidelines for children, lack of training in child psychology, obscurity of health-care worker roles in counselling children and inflexible facility working hours and user fees.

Linkage to care and ART initiation (264266)

Barriers to linkage and ART include poor coordination and linkage between service delivery points, provider attitudes and difficulties with paediatric counselling and lack of health-care worker confidence in initiating ART in children.

ART adherence and viral suppression (267273)

ARV drug palatability, ARV drug side-effects and lack of suitable formulations for children may affect adherence to ART and subsequent viral suppression, and pretreatment HIV drug resistance, unavailability of optimal ARV drug regimens and suboptimal ART dosing affect viral suppression. In addition, poor-quality counselling services, inadequate psychosocial support and lack of health-care worker skills to undertake age-appropriate disclosure all affect adherence. Child-related factors that affect their adherence to ART include fatigue and lack of motivation, forgetfulness, refusal, peer influence and non-disclosure (153).

Retention (274277)

Several factors adversely affect retention, including poor-quality counselling and psychosocial support for children, inadequate health information systems to capture data for children, inadequate contact information, weak follow-up systems to trace children, high health-care worker workload, inadequate clinical and laboratory services for managing children, fragmented service delivery with multiple service points at the facility, lack of task sharing, lack of decentralization and drug stock-outs.

Barriers along the continuum of care

Cross-cutting barriers affecting HIV testing, linkage, ART adherence and retention include lack of child-friendly infrastructure and age-appropriate service delivery, long waiting times at health facilities, physical access constraints for caregivers including distance to facilities, transport costs and time, unavailability of food, fear and stigma among the families of children living with HIV, absence of parents and adult supervision, multiple caregivers with lack of coordination among them, children depending on adults for access, adherence and retention in care, lack of knowledge, caregiver’s perception of the child’s health and misconceptions about HIV infection among children.

Interventions

These guidelines provide the normative foundation of service delivery models that can improve outcomes among children, including recommendations for: service delivery for children outside the facility; child-centred service delivery; linkage of children from testing to care; rapid ART initiation for children; adherence to ART and retention in care; tracking children and re-engagement in care; task-sharing for child services; decentralization of HIV services for children; and service integration.

Tackling existing barriers and ensure that services for children are scaled up to maximize clinical outcomes requires analysing context-specific barriers to appropriately set priorities among and target a comprehensive set of high-impact interventions along the continuum of care (Fig. 7.2). UNICEF’s Improving HIV service delivery for infants, children and adolescents: a framework for country programming (278) is a service delivery framework highlighting interventions that improve services along a locate-link-treat-retain continuum and supporting system-strengthening elements and aiming to improve how HIV services are tailored to the epidemic context.

Fig. 7.2. Interventions across the continuum of care.

Fig. 7.2

Interventions across the continuum of care.

7.10.1. Locate and link

With low HIV prevalence among children 0–9 years old in the general population, mass population-based testing is not effective in identifying children living with HIV. Targeted HIV testing focusing on children who have a higher probability of HIV infection is a strategy that maximizes the yield of HIV testing and minimizes missed opportunities for identifying children living with HIV. Integrated approaches that include risk-based screening with validated tools especially for orphaned and vulnerable children (279,280), index family-based testing (281), testing of sick children (282,283) and point-of-care early infant diagnosis testing (284) would be critical. Chapter 2 provides details of the specific recommendations for HIV testing.

HIV testing of the biological children of index adults and biological siblings of index children diagnosed with HIV or in HIV care should be given priority. Identifying the most appropriate and acceptable setting for index family–based testing either at facilities or in the community will be important, providing appropriate disclosure and psychosocial support with linkage to ART for newly identified children living with HIV.

Strengthening existing infant testing systems for efficient and timely identification of children living with HIV is a priority. Where feasible, point-of-care early infant diagnosis technologies that are strategically positioned within the system, such as at high-volume facilities, and mechanisms for extending services to facilities in proximity can potentially improve the timely detection of HIV infection among infants with early linkage to treatment and care. Facilities providing point-of-care testing must have trained human resources and equipment maintenance and quality assurance measures in place. Alongside early infant diagnosis, continued efforts to strengthen testing beyond the early infant diagnosis time points with rapid testing later in childhood need to be emphasized to address the gaps in identifying older children that constitute the bulk of children and adolescents younger than 15 years living with HIV.

Robust client data management systems (and if possible, electronic systems) are essential to facilitate the tracing of children. Tracking mechanisms (phone call, text messaging, standard mail, email and in-person tracing including using peer models such as mentor mothers) can support the identification and follow-up of mother–baby pairs and the siblings and children of index clients for early infant diagnosis, family and index client testing and linkage to treatment and care.

A key step to targeted HIV testing is assessing risk using simple, context-specific screening tools with high sensitivity and specificity to identify children at high risk of HIV infection. The tools should be easy to administer by higher- and lower-level cadres. This requires standard operating procedures on implementing risk screening and procedures that link screening to HIV testing in specific documentation tools to be developed. A systematic review and meta-analysis of prospective and cross-sectional studies found that current screening tools have only moderate sensitivity and specificity and miss many children living with HIV in high-prevalence areas (285). Screening tools with high sensitivity and specificity therefore need to be developed since this is critical to correctly identifying children at high risk of HIV infection.

Alongside these efforts, it is important to ensure that health-care workers and lay workers are trained and supervised to implement the following:

  • targeted provider-initiated testing and counselling with rapid linkage to ART for all sick children in inpatient wards and those attending outpatient, TB and nutrition clinics;
  • family-index testing using standardized modalities for tracing children, engaging family members, family HIV testing in different settings, psychosocial support and linkage services both at facilities and in communities;
  • risk assessments as an integral component of the HIV testing algorithm for children; and
  • providing disclosure support.

7.10.2. Treat

Delay in initiating ART among children leads to increased morbidity and mortality. Early ART initiation for children living with HIV is a priority. Currently, HIV management remains largely physician-intensive, concentrated at higher-level health facilities and centres of excellence, limiting access to services. HIV treatment and care for children has been shown to be feasible in primary health-care facilities with increases in enrolment in care and ART initiation. However, children younger than two years are less likely to initiate ART in primary health care (286). WHO recommends decentralizing HIV services, including ART for children, to primary health-care facilities. To further improve access, early retention and timeliness of ART initiation, WHO also recommends initiating ART outside health facilities, rapid ART initiation (in the case of advanced HIV disease) and same-day ART initiation (if ready) for children. Although a foundational enabling environment that promotes treatment adherence and retention of children is preferred, pre-existing social barriers should not delay initiating ART but rather be addressed alongside ART through tailored and timely supportive interventions (peer counselling, psychosocial support and other services for vulnerable children).

Training, mentoring and supervising health-care workers and lay workers at primary health-care facilities and in communities will be critical to provide a high-quality comprehensive package of services using child-friendly service delivery approaches (including ART initiation and monitoring, caregiver education, disclosure and psychosocial support, adherence counselling, early childhood development and links to other services for vulnerable children) and clear referral mechanisms when further clinical and social services are needed. Case management by mobile phone (mHealth), tele-health and mobile teams are avenues through which higher-cadre clinicians can provide support to health-care workers and lay workers in primary health-care facilities and in the communities to build service delivery capacity and support the decentralization of services.

To date, decentralizing HIV care for children to lower-level facilities has been slow, with limited evidence of the outcomes of children receiving ART at primary health care facilities or outside health facilities. Evidence on the outcomes and effectiveness of decentralized HIV care for children is needed for scale-up. The evidence supporting case management by mobile phone (mHealth), although promising, is still in the early stages (287). Further research on its applicability and impact on children’s health outcomes in various contexts needs to be carried out.

Chapter 4 provides the recommendations for ART initiation for children, and section 7.8 provides recommendations for decentralizing treatment.

For child-friendly service delivery, see UNICEF’s Improving HIV service delivery for infants, children and adolescents: a framework for country programming (278).

7.10.3. Retain

Several approaches support the retention of children in care, including peer support, such as mentor mothers; home-based adherence and psychosocial counselling; appointment systems; mobile SMS reminders; point-of-care viral load monitoring; community-based services; and differentiated service delivery. All contribute to reducing attrition and improving ART adherence and viral suppression (288290).

Policies for community service delivery and differentiated service delivery approaches for children that define eligibility, the building blocks (what, when, who and where) in different contexts, guidelines for monitoring children in differentiated service delivery models and criteria for referral will enable these approaches to be scaled up for children, improving adherence and retention in care.

In addition, investing in the training, mentoring and supervision of health-care workers, lay workers and peer service providers to deliver relevant high-quality comprehensive service packages (including clinical components, adherence and psychosocial support) at facilities and in communities that are tailored to the needs of individual children is fundamental. Engagement of community actors, including caregivers, community leaders and community-based organizations, may be considered to support stigma reduction efforts, enable community delivery and encourage sustainability.

Section 7.11 provides details on recommendations for community and home-based adherence and psychosocial support.

Differentiated service delivery

Children who are established on ART are eligible for differentiated service delivery (see the WHO criteria for determining whether a child has been successfully established on ART in section 7.3). Differentiated service delivery for children, although child-centred, should be harmonized with differentiated service delivery for their caregivers in a family-centred approach. The following table summarizes the guidance for differentiated service delivery for children 0–9 years old.

There are several models for differentiated service delivery for children, with wide variability in implementation, including multi-month refills, flexible hours, family clinics and community models. An innovative model is virtual case management or virtual support, especially for caregivers and families who have access to telecommunication services. Robust evidence of long-term retention and viral suppression among children is needed as well as streamlined guidance on eligibility criteria and implementation.

Section 7.3 provides details of recommendations for differentiated service delivery.

Re-engagement into care

Strategies for actively tracing children who have dropped out of care, standard protocols that ensure rapid follow-up and procedural guidance on the mechanisms, including multidisciplinary approaches to support re-engagement, should be developed. To facilitate this, efforts to routinely obtain consent and accurate contact details for community follow-up from caregivers are essential. Approaches for tracing children include phone calls, text messaging, mail, email and in-person tracing or a combination of these. Upon re-engagement, efforts to support retention of children should be emphasized, including counselling, disclosure, psychosocial support, peer support groups for caregivers and enrolment into appropriate differentiated service delivery models.

Table 7.2. Differentiated service delivery for children.

Table 7.2

Differentiated service delivery for children.

Box 7.6Differentiated service delivery models for children

The Elizabeth Glaser Pediatric AIDS Foundation carried out a programme and policy assessment of differentiated service delivery models serving children and adolescents implemented in seven countries in sub-Saharan Africa. The models included: multi-month refills, weekend clinics, school holiday clinics, child or teen clubs, family model of care and community-based models. They demonstrated a range of feasible differentiated service delivery models addressing children, but the policy analysis highlighted policy gaps limiting access to differentiated service delivery for children. Several countries lacked policies or guidelines that fully reflected the WHO differentiated service delivery guidance and eligibility criteria, resulting in variation in model structure and implementation, including eligibility criteria (291).

Other documented differentiated service delivery for children experiences include:

  • decentralized primary health care with outreach support for children and adolescents 0–16 years old (Zambia) (292);
  • Standardized Paediatric Expedited Encounters for ART Drugs Initiative (SPEEDI) (52); and
  • family clubs (Khayelitsha, Cape Town, South Africa) (293).

7.10.4. Cross-cutting interventions along the continuum of care

Task sharing

Since 2013, WHO has recommended that trained non-physician clinicians, midwives and nurses can initiate first-line ART and maintain ART (190). In 2016, WHO specified that these recommendations apply to all adults, adolescents and children living with HIV (3). However, programme experience suggests that task sharing has not sufficiently extended to children. Across many settings, doctors continue to initiate treatment, especially for younger children in hospital settings. An evaluation of health-care worker values and preferences in task sharing for initiating and maintaining treatment for children undertaken by the PATA network in 2020 highlighted challenges inherent in task sharing, including complexities associated with advanced HIV disease, suboptimal formulations and dose adjustments that may undermine nurse and midwife competence and confidence. Task sharing is critical and urgent to accelerate ART coverage among children.

This entails revising the regulatory framework and investing in preservice and in-service training on ART for children for nurses and midwives, providing regular clinical mentoring and supportive supervision, remote support (virtual platforms and hotlines), delineating roles and ensuring harmonization across all the cadres and levels of care. Standard operating procedures should provide clear indications, pathways and systems for referral to mid- and senior level cadres such as clinical officers and doctors (63). Evidence for task sharing models in care for children is limited. More evidence on task sharing and the outcomes of children in various contexts needs to be generated to inform policy.

Peer programming

Using peer approaches, especially in programmes for preventing mother-to-child transmission, is a low-cost, effective and acceptable intervention for improving children’s health outcomes and timely presentation for early infant diagnosis and retention in care (294,295). Peer programming provides another opportunity for task-sharing. Provided with adequate training, supervision and tools, peers can support health-care workers and facilities to execute tasks, including caregiver education and psychosocial support, adherence support, community delivery of ART and community follow-up. Policies should clarify the roles and responsibilities of peers, consider formalizing them within the service delivery systems and establish mechanisms for retaining these cadres.

Monitoring and evaluation systems should establish task sharing and peer programming indicators specific to children and quality assurance mechanisms that monitor the quality of services provided for children by each cadre against established competency levels and standards developed. Job aids, including dosing charts, caregiver counselling and education guides, should be provided to facilitate task sharing. Section 7.7 provides details on the recommendations for task sharing.

Assisted disclosure

Disclosure enhances adherence to ART, but the emotional and mental effects of disclosure to children vary (296,297). Qualitative data suggest that caregivers need support and counselling on approaching disclosure to children (298). Interventions based on an education model have been used to improve the knowledge and skills of caregivers and health-care workers on disclosure (299). Most countries have policies for disclosing HIV status to children in place. Health-care workers and lay workers should be equipped with adequate skills and aids to support the disclosure process in children and to provide post-disclosure support. Children with adherence issues should be assessed for disclosure status and age-appropriate disclosure planned based on their capacity to understand basic HIV concepts, cognitive development and emotional maturity.

In summary, stronger evidence of high-impact service delivery models for children and their caregivers is needed, tailored to the epidemic context, through robust well-conducted operational research that documents experience of programmes in pilots and scale-up and that builds evidence for the interventions in context to inform implementation and policy.

7.11. Service delivery for adolescents

An effective continuum of HIV care ensures that people are retained as they transition between health-care services and providers. Care transitions may be negatively affected by stigma and discrimination, fear of disclosure to new providers and anxiety or inconvenience resulting from changes in providers, their practice style and location. Examples of such changes include adolescents transitioning from paediatric care to adult care; pregnant and postpartum women transitioning from maternal and child health services to adult care; people transitioning from hospitals to primary care facilities; people transitioning from facility-based to community-based services and people in correctional facilities transitioning to general outpatient care. Effective planning and support are needed to ensure that these transitions occur as smoothly as possible.

7.11.1. Delivering high-quality HIV services to adolescents

Recommendations (2013)

  • Adolescent-friendly services should be implemented in HIV services to ensure engagement and improved outcomes (strong recommendation, low-certainty evidence).
  • Community-based approaches can improve treatment adherence and retention in care of adolescents living with HIV (conditional recommendation, very-low-certainty evidence).
  • Training health-care workers can contribute to treatment adherence and improve retention in care of adolescents living with HIV (conditional recommendation, very-low-certainty evidence).
  • Adolescents should be counselled about the potential benefits and risks of disclosing their HIV status to others and empowered and supported to determine whether, when, how and to whom to disclose (conditional recommendation, very-low-certainty evidence).

Source: HIV and adolescents: guidance for HIV testing and counselling and care for adolescents living with HIV: recommendations for a public health approach and considerations for policy-makers and managers (300)

Background

WHO recommends initiating ART among in all adolescents (10–19 years old) living with HIV regardless of CD4 cell count or clinical stage of disease. A growing cohort of 1.7 million adolescents living with HIV includes people infected from birth and those who acquired HIV later in childhood and adolescence (301,302). Although health outcome data for this age group remain limited, emerging evidence indicates that adolescents living with HIV are underserved by current HIV services and have lower access to and worse outcomes on ART than older age groups (303305). Adolescents are at high risk of loss to follow-up both before and after initiating ART, with older adolescents, pregnant adolescents, adolescent mothers living with HIV and adolescent key populations being especially vulnerable (304,306313). Peer-driven models of care have demonstrated impact on improving health-seeking behaviour and HIV treatment outcomes for adolescents living with HIV, such as linkage, adherence to ART, retention in care and viral suppression (314316).

Rationale and supporting evidence

Adolescents, including those living with HIV, face significant barriers to accessing health services, such as inadequate health literacy, limited ability to navigate health systems, legal requirements for parental or caregiver consent and insufficient resources to pay direct and associated service costs (317,318). Adolescents face significant levels of stigma and discrimination, especially adolescents from key populations, among whom criminalization of behaviour such as sex work, drug use and same-sex activity further perpetuates social exclusion and hinders access to health and support services (319,320). The rapid developmental and social changes that occur during adolescence exacerbate the impact of such barriers and can profoundly affect how adolescents engage with health services (321).

Poor-quality services also limit adolescent engagement in health care. Adolescents often perceive health services as unacceptable because of concerns about confidentiality and negative attitudes of health-care providers (319,320,322). Services are often not organized to accommodate adolescent needs and routines and have inconvenient service schedules, inflexible appointments and unwelcoming environments (320,321). Without sufficient attention and support, adolescents can be lost between services for children and services for adults.

Because of their specific needs, adolescents require high-quality comprehensive services and care to support access, retention and adherence. This includes psychosocial support, sexual and reproductive health and mental health care (321,323). The principles of adolescent-friendly health services are outlined in the WHO-defined characteristics of adolescent-friendly health services (Box 7.7) (322,324).

Box 7.7WHO-defined characteristics of adolescent-friendly health services

Equitable: All adolescents, not just certain groups, are able to obtain the health services they need.

Accessible: Adolescents are able to obtain the services that are provided. Acceptable: Health services are provided in ways that meet the expectations of adolescent clients.

Appropriate: The right health services that adolescents need are provided.

Effective: The right health services are provided in the right way and contribute positively to the health of adolescents.

A systematic review (3) was undertaken to assess the effectiveness of adolescent-friendly health services for adolescents living with HIV compared with the standard of care. Because of the limited evidence available, the review was expanded to include adolescents and young adults up to and including 24 years of age. Adolescent-friendly health services were defined according to the WHO characteristics and the global standards for high-quality health-care services for adolescents. Eleven randomized controlled trials (325335) and eight observational studies (336343) from four of the six WHO regions were identified. Four studies focused on adolescents living with HIV; the remainder focused on sexual and reproductive health, HIV prevention, mental health, diabetes, general health and smoking cessation. All studies included two or more of the WHO characteristics and global standards for high-quality health-care services for adolescents. Only one study included all WHO characteristics, and no study addressed all global standards.

Adolescent-friendly health services, approaches and interventions compared with standard care showed small but significant improvements in various outcomes, including health outcomes (lower pregnancy rates); health care utilization (presentation at a clinic for mental health, HIV counselling and testing and outpatient visits); uptake of services (HIV testing); knowledge (acquiring HIV and sexually transmitted infections, preventing pregnancy and sexual health); attitudes (towards sex and HIV testing); sexual risk-reduction behaviour (condom use); self-efficacy (condom use or diabetes management); and service acceptability. Outcomes related to healthy lifestyles and quality of life did not differ. Among young people living with HIV exposed to adolescent-friendly health services compared with the standard of care, there was improved short-term viral suppresion and long-term ART adherence. The overall certainty of evidence is low. The Guideline Development Group made a strong recommendation despite low-certainty evidence, citing the promising improvement in outcomes and the existing programme experience, evidence of feasibility and acceptability by the end-users (3).

Cost and cost–effectiveness

A cost modelling study and a retrospective cost analysis for adolescent-friendly health services in low- and middle-income countries reported that, although additional resources are required to ensure the delivery of high-quality adolescent-friendly health services, investments to implement and scale up these services – especially services providing multiple interventions – appear to have value and impact for adolescents (344,345).

Equity and acceptability

Adolescent-friendly approaches aim to ensure that all adolescents obtain the health services that they need, that policies and procedures are in place to facilitate the provision of health services to adolescents and that all health-care providers treat adolescents with equal care and respect regardless of HIV status or risk behaviour.

A global consultation of 470 young people living with HIV and a situational analysis of more than 200 facilities in the WHO African Region was undertaken (320,346); additional input from two unpublished multicountry longitudinal qualitative studies with 147 adolescents living with HIV was also considered (3). Key themes and suggested strategies for improving service delivery focused on empowered and solution-oriented information and support; opportunities for open and honest discussion; skills development on sexual and reproductive health and HIV disclosure from an early age; comprehensive care that addresses issues beyond HIV, including support for adolescents from key populations; flexible scheduling of clinic visits to accommodate school hours; services free of charge closer to home and community-based; dedicated hours and spaces for adolescents; peer-led interventions and services; and an adolescent-competent workforce.

Further, since adolescents living with HIV are a heterogeneous group with varying needs, expectations, preferences and vulnerabilities, care should be taken to ensure equity in service delivery across the age band, paying particular attention to especially vulnerable adolescents, including those from key populations. Relevant WHO guidance and tools are available to facilitate the equitable implementation of adolescent-friendly approaches and programmes, which should consider differentiated intensity and frequency of services for adolescents (21,347).

Feasibility

Programmatic and facility-level evidence suggests that providing adolescent-friendly health services is feasible. A situational analysis of over 200 health facilities in the WHO African Region found that 35% of facilities were attending to adolescents living with HIV separately from adults and/or children through dedicated schedules, staff and/or spaces (311). A case study of a government ART clinic in South Africa found that providing adolescent-friendly approaches in an HIV service setting is feasible. Although the financial costs were low, consideration needs to be given to ensure the engagement of stakeholders, including adolescents; adolescent-specific training for health-care providers and minimal rotation of providers; and adequate time for planning restructured services. A survey of national HIV programme managers highlighted a lack of appropriately trained health-care workers and the need for greater preparation of health-care services as key challenges in delivering HIV services to adolescents (3).

Experience in Zimbabwe has identified several requirements for scaling up adolescent-friendly HIV services, including a national, multisectoral, coordinated response; adolescent-sensitive policies and guidelines; meaningful involvement of adolescents; training and sustained mentorship of health-care providers; community system strengthening; linking community interventions with health facilities; and a national monitoring and evaluation framework with disaggregation and clear indicators for adolescents.

Implementation considerations

The WHO global standards for high-quality health-care services for adolescents provide an approach to improving the services provided to adolescents (72). Examples of how these standards can be adapted to HIV services are available (Box 7.8) (316). The standards are accompanied by an implementation guide that highlights the necessary steps at the national, district and facility levels to achieve the standards and assessment tools to measure implementation (72).

Box 7.8Global standards for the quality of health-care services for adolescents and HIV-related activities aligned to the standards

Global standardDescriptionExample of activities implemented to attain this standard
1. Adolescents’ health literacy The health facility implements systems to ensure that adolescents are knowledgeable about their own health, and they know where and when to obtain health services

Training of peer supporters, also adolescents living with HIV in HIV prevention, sexual and reproductive health, mental health and life skills

Developing job aids on HIV testing, care and treatment, viral load monitoring, adherence counselling and contraceptive information and provision specific to adolescents

Peer supporters and treatment literacy staff address HIV knowledge and adherence and the concerns of adolescents

2. Community support The health facility implements systems to ensure that parents, guardians and other community members and community organizations recognize the value of providing health services to adolescents and support such provision and the utilization of services by adolescents

their caregivers join clubs and are involved in activities both between and within clubs

Conducting sensitization sessions within schools to eliminate stigma and promote testing, adherence and retention by school-attending adolescents living with HIV

Engaging parents and guardians during caregiver sessions and introducing the services

3. Appropriate package of services The health facility provides a package of information, counselling, diagnostic, treatment and care services that fulfils the needs of all adolescents. Services are provided in the facility and through referral linkages and outreach

Standard operating procedures developed and implemented to provide standard and simplified information on the available package of services

Constitute a ministry-led multidisciplinary mentorship team on capacity-building for the needs of the adolescents

4. Providers’ competencies Health-care providers demonstrate the technical competence required to provide effective health services to adolescents. Both health-care providers and support staff respect, protect and fulfil adolescents’ rights to information, privacy, confidentiality, non-discrimination, non-judgemental attitudes and respect

Training health-care workers at service delivery points on providing adolescent-friendly health services within an integrated service package

Regular meetings, on-site support and mentorship and refresher workshops

Peer educator curriculum package and teen club guide for peers and health-care providers to use

5. Facility characteristics The health facility has convenient operating hours, a welcoming and clean environment and maintains privacy and confidentiality. It has the equipment, medicines, supplies and technology needed to ensure effective service provision to adolescents

Clinic appointment hours specific to adolescents and flexible opening hours outside regular clinic hours, such as evenings or weekends or school holidays to facilitate convenient hours and a safe space for HIV care and psychosocial support discussions

Multidisciplinary teams scheduled to provide different services; to refill ARV medicine, conduct viral load testing and counsel clients

Develop and adhere to the infection prevention and control policies

6. Equity and non-discrimination The health facility provides high-quality services to all adolescents regardless of their ability to pay, age, sex, marital status, education level, ethnic origin, sexual orientation or other characteristics

Services provided free of charge with no out-of-pocket expenses

Client satisfaction survey performed periodically to get feedback for improvement

Involvement of multilayered and multisectoral agencies, including social protection services and the district health team

7. Data and quality improvement The health facility collects, analyses and uses data on service utilization and quality of care, disaggregated by age and sex, to support quality improvement. Health facility staff members are supported to participate in continuous quality improvement

Develop and implement a monitoring and evaluation framework that clearly defines process and outcome indicators

Develop and implement standard data collection tools at the facility level and a reporting template that captures age, sex and outcomes

Quality improvement teams to routinely review disaggregated data and brainstorm for solutions with health facility staff and district councils

8. Adolescents’ participation Adolescents are involved in planning, monitoring and evaluating health services and in decisions regarding their own care as well as in certain appropriate aspects of service provision

Implementation of youth advisory groups and processes for design, implementation and feedback on services

Peer supporters taking part in relevant health team meetings such as case reviews and advocacy for adolescent-friendly health services

Training of peers to be self-health managers, to motivate self and others and to be a source of positive peer pressure to others

The implementation guide outlines further actions to implement the standards at the national, district and facility levels (72).

Adolescent peer-driven models and support are key implementation strategies towards the global standard of adolescent participation. The WHO technical brief on peer-driven adolescent HIV models of care (316) provides implementation considerations for adapting and scaling up peer-based, adolescent-friendly models and showcases five best-practice case studies based on country experience. The brief advises that peer support is best implemented alongside: routine assessments to monitor progress and quality; standardized peer counsellor recruitment; orientation, training and mentorship of peer counsellors and other stakeholders; deliberate and differentiated care of peer counsellors and health-care workers; and transition planning for peer counsellors ageing out of the programme.

Additional HIV-specific implementation considerations include:

  • integrating HIV services for adolescents living with HIV with other adolescent health services, such as those for mental health and sexual and reproductive health;
  • aligning approaches for HIV service delivery with WHO and national adolescent-friendly health service standards, protocols and activities;
  • including the implementation of adolescent-friendly approaches in HIV health service supervisory and monitoring systems;
  • ensuring training, research and personal development opportunities for health-care providers on adolescent HIV treatment and care;
  • engaging service providers, adolescents and other key stakeholders to identify acceptable and feasible activities;
  • implementing adolescent-friendly health service approaches in all HIV services accessed by adolescents, including antenatal care for pregnant adolescents living with HIV and adolescent mothers;
  • establishing links and referral pathways to ensure a comprehensive continuum of care, especially for the transition from HIV services for children to those for adults; and
  • addressing the needs and vulnerabilities of adolescents from key populations (70).

Relevant WHO guidance and tools are available (71,319,300,348,349352).

Research gaps

Although examples of excellence in adolescent-friendly health services for adolescents living with HIV exist (317,353355), programmes remain poorly documented, with limited scale, and quality and standards vary widely.

Research should contribute to improving understanding of how to implement adolescent-friendly health services within HIV services at a programmatic level and the cost–effectiveness of these approaches in resource-limited settings. Research on the service delivery needs of adolescents living with HIV should examine the minimum package of care; models of delivery at different service levels, including for key populations and pregnant adolescents living with HIV; integrating sexual and reproductive health into HIV services for adolescents; interventions to support safe disclosure; treatment literacy; interventions to address mental health; and the impact of provider training and peer interventions.

The WHO technical brief on peer-driven adolescent HIV models of care (316) advocates operational and implementation research to assess the effectiveness of and best practices within peer support programmes.

Supporting adolescent mental health and psychosocial well-being

Both the aforementioned WHO-defined characteristics of adolescent-friendly health services and the WHO global standards for high-quality health-care services for adolescents (72,322) highlight the importance of providing an appropriate package of services that fulfils the needs of adolescents. Almost 50% of all mental health conditions start before the age of 14 years, and up to one in five adolescents experience a mental disorder each year (356). Adolescents living with HIV are at increased risk of mental health disorders, such as depression and anxiety (356,357).

The WHO guidelines on mental health promotive and preventive interventions for adolescents provide evidence-informed recommendations on psychosocial interventions for adolescents 10–19 years old that can be implemented in schools, health-care settings, communities or through digital platforms (356) and are relevant within an HIV context.

7.11.2. Psychosocial interventions for adolescents and young adults living with HIV

Recommendation (2021)

Psychosocial interventions should be provided to all adolescents and young adults living with HIV (strong recommendation, moderate-certainty evidence).

Source: Updated recommendations on service delivery for the treatment and care of people living with HIV (63)

Background and rationale

The 2016 consolidated HIV guidelines detailed the key elements of general care over the continuum of HIV care for people living with HIV (3). However, adolescents and young adults living with HIV face distinct and interlinked challenges as they navigate the health-care system, take on responsibility for managing their own care and treatment and confront issues relating to stigma and disclosure (316). Specific guidance is therefore necessary to ensure that interventions specific to adolescents and young people are identified and evaluated.

Adolescence entails biological, cognitive and social changes. It is a phase in the life-course of increased exploration of identity, vulnerability and experimentation, and navigating this phase can be especially complex (358). Adolescents and young adults living with HIV experience numerous mental and social issues, including depression, stigma, isolation, difficulties with treatment adherence and retention, sexual risk-taking practices and substance use (359). In addition, evidence indicates that these people are underserved by current HIV services and, compared with adults 25 years and older, have significantly worse access to and coverage of ART, worse suppression of viral loads and a high risk of loss to follow-up both before and after initiating ART (3).

Psychosocial interventions, which adopt psychological, social and/or behavioural approaches to developing skills and knowledge, have been introduced across a variety of sociodemographic settings, but these interventions have not been adequately explored as a whole.

A systematic review assessed the effect of psychosocial interventions on ART knowledge, linkage to care, adherence to ART, retention in care, viral load, sexual and reproductive health behaviour and knowledge and improved transitioning to adult services. Thirty randomized controlled trials of psychosocial interventions for adolescents and young adults were identified (360). Psychosocial interventions improved adherence to ART (standardized mean difference 0.39, 95% CI 0.11–0.68); reduction in viral load (standardized mean difference – 0.26, 95% CI –0.45 to –0.07) and led to increased viral suppression (odds ratio 1.9, 95% CI 1.0–3.8) and undetectable viral load (odds ratio =1.8, 95% CI 1.1–3.1). No undesirable effects were identified. The Guideline Development Group judged the certainty of evidence to be moderate.

The systematic review described the following psychosocial interventions:

  • interventions that harnessed motivational interviewing, a collaborative, client-centred counselling style focused on increasing motivational readiness for behavioural change (361366);
  • interventions that involved adolescents and their caregivers: family-based interventions to promote mental health and prevent negative behaviour (such as nonadherence) among adolescents with HIV, which are designed to strengthen communication, problem-solving and negotiation skills for both adolescents and caregivers (367);
  • interventions based around peer support and social networks, which are peer-driven interventions involving multiple intervention components to target adolescents and young adults living with HIV and improve outcomes, including adherence to treatment, retention in care and suppression of viral loads (314,368370); and
  • digital means used to introduce new information and deliver behaviour change skills (371375).

Benefits and harm

Overall, the net effects on adherence and suppression of viral loads were positive. There were no undesirable effects, and the interventions improved adherence and viral load outcomes. The Guideline Development Group judged the benefits to be moderate and harm trivial.

Feasibility, cost and cost–effectiveness

Overall, psychosocial interventions for adolescents living with HIV were found to be feasible to implement (314,376,377). Many studies reported low attrition rates, indicating that interventions were feasible and well accepted (362,367,378,379). The location of the intervention also influenced feasibility, with interventions delivered digitally or at home considered more feasible because of convenience and flexibility (369,380).

Comprehensive training of existing or new personnel and integrating interventions into existing health-care settings were important for successful implementation (365,381,382). Other feasible interventions used existing support networks to improve engagement in care (368).

There is potential for digital interventions and delivering support through virtual platforms (383). There is an opportunity for delivering blended virtual and face-to-face psychosocial support to support access to equitable and wide-scale services.

Information on the resources used and the cost were extracted as part of the systematic review. Short-term increases in the costs of widespread implementation may offset the longer-term economic and social costs of failing to promote the suppression of viral loads for adolescents living with HIV (314). Psychosocial interventions designed to be implemented by lay counsellors or peer mentors are relatively inexpensive (367,376,378,384). Costs may be reduced by using digital strategies for delivery (371,379). The effects of digitally delivered interventions have been identified as being comparable to or even better than those of in-person interventions (378). Conversely, labour-intensive interventions are more costly (379). Training and employing new personnel to deliver interventions also involve costs. The Guideline Development Group judged the certainty of evidence on costs and resource requirements to be moderate.

Equity and acceptability

Psychosocial interventions are likely to improve equity, especially for more vulnerable groups such as adolescent girls and young women, pregnant adolescents, adolescent mothers and key population groups, and in contexts of high youth unemployment and persistent HIV stigma. The systematic review showed improvements in health equity when approaches are introduced to provide structural support and optimize the potential of peer support and networks and when considering gender preferences for psychosocial support interventions (385387). The widespread provision of psychosocial services enables adolescents living with HIV to have a more equitable chance to benefit from optimal HIV outcomes by ensuring that each young person receives adequate support to enable them to live physically and mentally well with HIV. The Guideline Development Group judged that offering psychosocial interventions to adolescents and young adults living with HIV would probably increase equity.

A global consultation of adolescents and young adults living with HIV was conducted among 388 respondents across 45 countries, supplemented by 10 focus group discussions with 61 adolescents and young adults with HIV across 10 countries (63). There was near universal agreement (95–98% of respondents) that psychosocial support interventions would help substantially across the HIV cascade and a range of outcomes. Psychosocial support was considered critical to both the mental and physical health of adolescents and young adults living with HIV. The findings demonstrate that psychosocial support is desired and preferred and described as being potentially transformative across HIV treatment outcomes (diagnosis and initiating ART, adherence, retention in care, suppression of viral loads, mental health and sexual and reproductive health and rights). The findings show that adolescents and young adults living with HIV want to receive sustained psychosocial support at each stage of the HIV cascade (63).

Adolescents and young adults living with HIV prefer a varied package of psychosocial interventions, but they consider peer support especially important in managing their health. Interventions that focus on strengthening support from trusted family members and health-care workers are also desired.

Another survey was implemented among frontline health-care workers to assess a wide range of service delivery practices, gaps and enablers (388); 324 health-care workers from 30 countries, primarily in sub-Saharan Africa, participated. At each step in the treatment cascade, the health-care workers reported psychosocial issues as major challenges and recommended psychosocial support strategies more than any other type of intervention. The Guideline Development Group found no important variability on preferences and acceptability.

Implementation considerations

A package of services should be considered that is both acceptable and feasible within the context in which they are to be delivered. This package should be differentiated according to the needs and experiences of different subpopulations of adolescents and young adults living with HIV.

Some adolescents and young adults living with HIV may require adaptations to the content and/or delivery of psychosocial programming to meet their needs. These include adolescents and young adults: with disabilities; who are living with mental health conditions or substance use; who are in and out of school; who are orphans; who are members of ethnic minority groups; who are lesbian, gay, bisexual, transgender, queer or intersex (LGBQTI); who are pregnant; and who are living in contexts of adversity such as extreme poverty and/or humanitarian emergencies. In addition, differences in exposure to risks and protective factors depending on age, developmental stage, sex, health status, whether they belong to a key population and context need to be considered.

Evidence supports psychological approaches such as motivational interviewing and cognitive behavioural therapy. Programmes can include goal setting, problem solving, coping skills, healthy daily routines, interpersonal and communication skills, activating social support and other strategies. Interventions can be delivered through a range of delivery modalities and health-care workers, including clinic visits, home visits, support groups (including peer support and groups that link psychosocial support with ART delivery such as teen clubs), social media and telephone contact. These should be fully integrated within the package of clinical services to optimize impact. Facilitators should be able to develop supportive, trusting, non-judgemental relationships, to maximize engagement in programming; this requires investing in ongoing training, supervision and support for facilitators.

Interventions should be implemented in keeping with the global principles and standards for providing high-quality health-care services for adolescents. The highest ethical standards should be maintained, including voluntary participation, confidentiality, privacy and the best interests of each adolescent and young person. Failure to participate should not affect access to ART or other services.

Peer-driven approaches and the participation and engagement of adolescents are necessary facilitators. The meaningful involvement of adolescents and young adults living with HIV in planning, developing, implementing and evaluating interventions may promote the acceptability and uptake of interventions.

Community support and the involvement of parents, guardians, schools, and other community members in programmes may provide important support for programmes and promote their success.

Research gaps

Additional research is required to identify interventions that improve outcomes for different groups of adolescents and young adults living with HIV. Importantly, research is also needed on content and delivery strategies for interventions to involve parents and caregivers, for both younger and older adolescents, to assess the effectiveness of these programmes.

Further research is needed to inform feasible and effective training, supervision and implementation of support models at scale for facilitators of psychosocial interventions, including peer providers.

There is an ongoing need for research and programme evaluation from resource-limited settings on psychosocial interventions for this group, which would be further supported with more data on the costs and cost–effectiveness of interventions that are currently limited. To further inform implementation, intervention studies should aim to include methods to capture and report costs.

In addition, to enhance the comparability of study findings, intervention studies are encouraged to use standardized outcome definitions to report critical outcomes.

Lastly, follow-up beyond the immediate post-intervention period is needed to understand the long-term impact of psychosocial interventions.

7.12. Improving the quality of HIV care services

Background

This section provides guidance for HIV programme managers and health-care providers on improving the quality of HIV care services. It focuses on key principles, approaches and interventions and provides practical examples of quality assurance and quality improvement practices. HIV programmes should not limit themselves to the examples provided but rather should seek innovative and locally sustainable solutions that strengthen programme monitoring and routine use of programmatic data to improve the quality of HIV care services.

Quality of care emphasizes that services should be effective in achieving their desired health outcomes and that health-care practices should be people-centred and safe (389). The WHO global guidance on people-centred and integrated health services outlines the quality-of-care strategy and provides an overview of evidence and good practices (390,391). Strategies to improve the quality of HIV care services are needed both at the programme management level and at the health facility and community levels where HIV care services are provided (391). If an intervention is to achieve its desired health outcomes, it should be evidence-based, complexity-informed, of high quality and achieve a level of coverage sufficient to bring desired outcomes to the population level.

Rationale for strengthening quality of HIV care services

Although significant progress has been made towards ending AIDS as a public health threat, with 25.4 million of the 38 million (67%) people living with HIV receiving ART by the end of 2019, many opportunities remain to improve access to health services and optimize the quality of service delivery. Opportunities for improvement span the entire care cascade. Opportunities include increasing access to primary prevention interventions such as PrEP and HIV testing and extending to increased ART access and initiation, supporting retention in HIV care and adherence to ART and increasing access to viral load testing among people receiving HIV treatment. Since fewer than half the people living with HIV (41%) have achieved viral load suppression on ART, the risk of substantial population-level HIV transmission and transmission of drug-resistant HIV remains. Other quality gaps remain that present additional opportunities for important changes and include ongoing elevated HIV incidence and mortality and must be addressed by improving HIV care and treatment programmes to achieve the goals outlined in the United Nations Political Declaration on HIV and AIDS. Finally, equity and human rights gaps exist: key populations remain underserved, experience persistent stigma and discrimination and are subject to criminalization, violence and other human rights abuses (390).

To address existing gaps in HIV care services and reach global targets, HIV programmes should establish and maintain systems for ensuring consistently high levels of quality in service delivery. These systems should exist within national frameworks for universal health coverage and be supported by national quality policies and strategies. Three 2018 publications (389391) highlight the implications of inadequate quality of health care. Each year an estimated 5.7 million to 8.4 million deaths can be attributed to poor-quality health care each year in low- and middle-income countries – a figure that accounts for up to 15% of overall deaths in these countries (391). Inadequate quality of care accounts for more deaths than lack of access to health services and leads to annual economic losses in excess of US$ 6 trillion (392).

WHO’s 2016 consolidated HIV guidelines (3) put forward the following good practice statements for HIV care services that reflect the broader WHO global strategy on people-centred and integrated health services.

Good practice statements (2016)

HIV programmes should:

  • provide people-centred care that is focused and organized around the health needs, preferences and expectations of people and communities, upholding individual dignity and respect, especially for vulnerable populations, and engage and support people and families for informed decision-making to play an active role in their own care;
  • offer safe, acceptable and appropriate clinical and non-clinical services in a timely fashion, aiming to reduce morbidity and mortality associated with HIV infection and to improve health outcomes and quality of life in general; and
  • promote the efficient and effective use of resources.

Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach – second edition (3)

More specifically, with respect to HIV care serviced and in accordance with the 2016 WHO consolidated HIV treatment guidelines (3), high-quality HIV services should:

  • provide people-centred care;
  • offer safe, acceptable and appropriate clinical and non-clinical services; and
  • promote the efficient and effective use of resources (393).

In additional, HIV services should focus attention on:

  • positive user experiences and attention to the patient voice (394);
  • measuring and reducing stigma and discrimination, especially in the health system (395); and
  • promoting and sustaining a culture of quality in the programmes and organizations delivering services (396).

WHO technical products on delivering high-quality HIV services

In 2018, WHO published a handbook to support low- and middle-income countries in developing national quality policies and strategies in the context of universal health coverage (393) and has published a report with OECD and the World Bank (389) that includes a quality call to action (Fig. 7.3).

Within HIV guidelines, WHO has issued recommendations on quality standards (393), high-quality HIV testing (397) and improving the quality of HIV clinical services (3).

Fig. 7.3. The quality call to action.

Fig. 7.3

The quality call to action.

Box 7.9How does WHO define high-quality health services?

High-quality health services must be:

  • effective: providing evidence-informed health-care services to those who need them;
  • safe: avoiding harm to people for whom the care is intended; and
  • people-centred: providing care that responds to individual preferences, needs and values.

In addition, to realize the benefits of high-quality health care, health services must be:

  • timely: reducing waiting times and sometimes harmful delays for both those who receive and give care;
  • equitable: providing care that does not vary in quality on account of age, sex, gender, race, ethnicity, geographical location, religion, socioeconomic status or linguistic or political affiliation;
  • integrated: providing care that is coordinated across levels and providers and makes available the full range of health services throughout the life-course; and
  • efficient: maximizing the benefit of available resources and avoiding waste.

Source: Why quality universal health coverage? (398)

High-quality HIV services include the reliable delivery of people-centred clinical care across diverse community and facility settings that are integrated with other services such as maternal, newborn and child health services (394) at the national, subnational, district and facility levels. Delivery of high-quality services depends on the strength of an underlying health system foundation and includes optimized management, funding, human resources, information systems, procurement of high-quality pharmaceuticals and devices as well as laboratory supplies and commodities.

National HIV programmes should ensure quality management (389,390,392,399,401) through necessary structures, functions and processes to support the delivery of high-quality HIV services.

Box 7.10Quality management: defining terms

Countries, programmes and organizations use a wide variety of terms to denote systems and processes related to the quality of care. The overview of terms presented here introduces key concepts rather than universally agreed definitions. Indeed, many terms presented here are used interchangeably or may have different connotations in different country or programme contexts. Efforts to address quality should not be hindered by differences in models, approaches or language, and stakeholders should attempt to create a shared understanding of the activities required to improve quality across a system or programme.

Quality management refers to all activities of the overall management function that determine quality policies, objectives and responsibilities and that implement them by such means as quality planning, quality assurance and quality improvement.

  • Quality planning includes overall quality objectives, priority indicators, governance, organizational structure, selection of health service personnel, allocation of resources, monitoring and evaluation and design and oversight of quality improvement and assurance initiatives.
  • Quality assurance, in the context of delivery of health services, refers to a range of activities related to systematic assessment and monitoring, intended to ensure that services are fulfilling stated requirements for quality. These include measuring performance against standards; performing external evaluation (such as accreditation); communicating standards to users; and monitoring compliance with established standards. Examples used within HIV programmes include Site Improvement through Monitoring System visits at sites of the United States President’s Emergency Plan for AIDS Relief (PEPFAR); site-level assessment of quality indicators; quality assurance checklists for HIV rapid tests; and supportive supervision.
  • Quality improvement is a specific method designed to continually improve performance as part of a routine process, generally applied by health facility teams within a national quality improvement programme, designed to test changes in programme services, continually measure the effects of these changes and use data to address gaps to improve clinical performance and health outcomes over time.

Sources: Handbook for national quality policy and strategy: a practical approach for developing policy and strategy to improve quality of care (300) and Juran & Godfrey (400).

There are numerous definitions of quality-related terms globally in various settings; these were selected in consultation with experts from the HIVResNet Working Group on Prevention of HIV Drug Resistance and Quality of Care.

Quality planning: how should national programmes ensure high-quality HIV services?

1.

Incorporate quality concepts into national HIV policy, strategic plan, strategic information framework and operational and service delivery plans. The quality of services should be assured at all health system levels, from national programme management to service delivery, within monitoring systems and as part of a continual process to improve health and clinical outcomes (Fig. 7.4) (3).

Fig. 7.4. Enablers of quality HIV services.

Fig. 7.4

Enablers of quality HIV services.

2.

Ensure that these elements are supported by a clearly articulated national directives on quality, as described by the WHO Handbook for national quality policy and strategy (399)

A national quality policy and strategy are organized efforts by a country to promote and plan for improving the quality of care across the health system and support leadership and ownership of high-quality HIV efforts by national health authorities, ensuring integration with both broader national health planning and other disease- or population-specific programmes. The national quality policies and strategies handbook outlines a non-prescriptive approach to developing policies and strategies to support high-quality health programmes and services. The approach includes focusing on eight interdependent elements that help countries to establish their national direction on quality of care (Fig. 7.5).

Fig. 7.5. Eight core elements to produce a national quality policy and strategy.

Fig. 7.5

Eight core elements to produce a national quality policy and strategy.

Fig. 7.6 illustrates how high-quality HIV services can be considered at different levels; actions to optimize the quality of care are necessary, and possible, at all levels of a health system. However, each country and level should develop its own set of interventions based on local context, need, feasibility, evidence and implementation experience.

Fig. 7.6. HIV quality interventions pyramid: how high-quality HIV services may be considered at different levels.

Fig. 7.6

HIV quality interventions pyramid: how high-quality HIV services may be considered at different levels.

Quality management strategies and frameworks, including those related to reducing stigma and discrimination, provide activities that occur at multiple levels of the health system. These activities go well beyond clinical audits and routine quality assessments and include community-based monitoring. Ideally, quality management strategies should also be considered at a systemic level, including not only different health-care system levels but external factors affecting HIV (such as food insecurity and social inequality). Designing effective, locally appropriate and sustainable quality management strategies requires a shift in thinking from a reductionist, linear approach towards a systemic understanding of the complexity of HIV care. One key characteristic of complex systems is that successful resolution of a problem in one of the elements of a system does not guarantee resolution of core issues. Indeed, a change in one aspect may have unintended negative (or positive) consequences in other parts of the system. Thus, thorough understanding of the complex system, its dynamics and feedback loops is therefore vital to identify points in the system at which interventions are most likely to improve the quality of care and the overall system (3).

Quality assurance: monitoring service delivery standards

Quality assurance is a common term and has different meanings in different contexts. In relation to delivery of health-care services, quality assurance generally refers to a range of activities related to systematic assessment and monitoring intended to provide assurance that services are fulfilling the stated requirements for quality. National quality assurance systems comprise organizations and processes, usually external to health-care providers, aimed at defining, monitoring and improving the quality of care. These may include standard-setting and guideline development bodies, professional registration and licensing boards and external evaluation organizations and programmes. HIV programmes should consider what mechanisms can be used to set appropriate standards, effectively monitor the quality of the services provided, aligning when possible with broader health system approaches to assurance and build accountability into the management of the programme. The 2017 WHO consolidated guidelines on person-centred HIV patient monitoring and case surveillance (402) describe patient-level services and indicators across the prevention and care and treatment cascade. Indicators focus on both patient care and management and programme monitoring and management (case surveillance data) use cases. These are anchored to WHO clinical guidelines and may provide a useful starting point for identifying HIV-specific considerations to be integrated within quality assurance tools and systems. The WHO consolidated guidelines on HIV testing services (9) provide guidance on quality assurance of HIV testing, and the WHO tool to set and monitor targets for HIV prevention, diagnosis, treatment and care for key populations (403) includes quality-related indicators and checklists.

Quality improvement: monitoring performance measures and using data for action

Improving the quality of health-care delivery requires a systematic approach and use of standardized indicators, exploring the root cause of selected gaps in service delivery and leading to designing and implementing contextually appropriate solutions whose impact is subsequently assessed (404). Implementing quality improvement initiatives requires robust data collection, reporting and using indicators. Interoperable information systems (such as client-level and aggregate) help to measure the quality of services, fill gaps in knowledge and communication to end-users, such as district health management teams and facility-level quality committees. Many HIV programmes currently use quality improvement methods that are selected based on available local capacity, resources and the availability of relevant tools and experience. Regardless of preferences about which model to use, HIV programmes seek to institutionalize a culture of quality improvement and build the necessary capacity for improvement across all levels.

Quality improvement involves the combined efforts of a variety of stakeholders to make changes that will lead to better programmes and systems and ultimately improve health outcomes (Fig. 7.7). There are many quality improvement models, including the model for improvement (405), Six Sigma, lean, total quality management and others. Many of these models use the plan-do-study-act cycle, which is used to continually improve health system performance (406).

The 2015 WHO consolidated strategic information guidelines for HIV in the health sector (407) present a framework based on the 90–90–90 targets and include prevention, care and treatment indicators recommended for routine reporting from the service delivery (facility or community) level to the central level, with a subset designated for global reporting. The specific set of indicators of the quality of services selected by a country depends on several factors. Whenever possible, approaches for measuring the quality of HIV services should be integrated with national quality measurement systems and provide disaggregated analysis by sex, age and specific key populations, such as pregnant women, men who have sex with men, people who inject drugs, female sex workers or people living with HIV who have TB, and the 90–90–90 indicators and others can be used to perform cascade analysis to identify programme bottlenecks and frame a set of linked indicators to assess and improve performance (Fig. 7.8).

Fig. 7.8. Cascade analysis for HIV testing services and index testing.

Fig. 7.8

Cascade analysis for HIV testing services and index testing.

The Monitoring and Improvement subgroup of the HIVResNet Working Group on Prevention of HIV Drug Resistance and Quality of Care gave priority to including patient experience indicators in national quality improvement frameworks. In addition, the 2018 report by the Lancet Global Health Commission on High-Quality Health Systems on the Sustainable Development Goals era (392) highlighted positive user experience as a key component of high-quality health services, proposing illustrative indicators. Patient-reported experience indicators (409) such as avoidance of health care among key populations because of stigma and discrimination are of key importance.

The WHO standards on maternal and newborn care (396) include standards reflecting communication and dignity (Standards 4 and 5) that can be considered for HIV programmes. Further efforts are required to capture such dimensions of the quality of services as compassion and patient experience (392), and WHO is working on standardizing associated methodological approaches. Finally, indicators reflecting the engagement of communities and demand-side factors are also important. These may include the satisfaction with clinical services of the recipients of care but also address community perceptions and values around what constitutes high-quality health care, which may vary in different settings and cultures.

Operationalizing national quality policies and strategies within HIV programmes

In many countries, HIV programmes already have well-established quality management processes, offering (1) an opportunity for integration with efforts in national quality policies and strategies, (2) opportunities for HIV programmes to be the pathfinder for national quality policies and strategies (bringing experience, lessons and a foundation for initially rolling out the strategy) and (3) entry points for strengthening the national system for quality of care.

Monitoring as a vital role for communities to improve quality of care

Community-led monitoring is one tool from the array of community-led interventions that people living with and affected by HIV can contribute. Community-led monitoring and consequent advocacy is a central tenet of quality improvement processes for health-care services that enables recipients of care to assess the quality, effectiveness and accessibility of health programmes and services. Community-led monitoring places the recipient of care at the centre of monitoring and advocacy and is implemented using various approaches led by communities in collaboration with other key stakeholders. It can be conducted by independent, local community organizations or a committee of community representatives at the local, national, regional and global levels.

The foundation for effective community-led monitoring and advocacy is HIV prevention and treatment education. When communities are aware of and fully understand prevention, treatment and care standards, they are able to determine indicators that are most appropriate and relevant to track over time. Communities then gather quantitative and qualitative data and observations of health service implementation and uptake aimed to assess the acceptability, availability and accessibility of services. The process must be routine and implemented at least semiannually, in collaboration with local health-care officials. The goal is to enable recipients of care to provide structured input on health-care services, based on evidence and experience, through a collaborative and solutions-oriented process.

The metrics of assessment and feedback must be tailored to the health-care needs identified by local communities. Through a consultative process, the communities support the development of the metrics, measures and tools to be used for community-led monitoring and advocacy.

There are five parts to community-led (or community-based) monitoring: data collection, analysis and translation, engagement and dissemination, advocacy and monitoring (Fig. 7.9).

Fig. 7.9. Five steps of the community-based monitoring cycle.

Fig. 7.9

Five steps of the community-based monitoring cycle.

Examples of community-led monitoring models range from suggestion boxes and client satisfaction surveys to health facility committees and comprehensive community treatment observatories. Feedback mechanisms ideally are present at each service point or health unit rather than being centrally located in larger facilities such as hospitals. The collective health-care staff should routinely review feedback, and the importance of visibly addressing concerns must be reinforced. Community-led monitoring and routine, active patient feedback mechanisms enable patients to take ownership of their health-care services and gives them a voice in the standards, availability and accessibility of services provided to them.

Through routine and structured community-led monitoring, communities are empowered to contribute to optimizing local health care structures. Community-led monitoring and related advocacy engenders accountability of service providers and local and national officials to standards of high-quality health care, including the availability and accessibility of services; such accountability leads to improved health outcomes (411). HIV multilateral donor and normative agencies (PEPFAR, Global Fund to Fight AIDS, Tuberculosis and Malaria, L’Initiative and UNAIDS) have increasingly acknowledged the importance of community-led monitoring and the related advocacy and have required recipient countries to include community-led monitoring in costed workplans (411,412).

Sustainability

HIV programmes need to implement and sustain quality management systems, especially in the context of wider universal health coverage and national quality policy and strategy efforts to reduce morbidity and mortality from HIV and reach the 95–95–95 targets, Sustainable Development Goals and targets and ending AIDS as a public health threat by 2030. Existing quality improvement efforts have been shown to positively affect clinical outcomes but will require commitment of resources from health ministries to be maintained. Evidence on the sustainability and cost–effectiveness of quality assurance and quality improvement efforts (as with many global health initiatives) and the expansion of proven interventions to large populations is very limited and often non-existent. Nevertheless, existing practical efforts to introduce a culture of quality awareness can be strengthened, as demonstrated by numerous country examples.

Addressing these requires planning, involvement of health ministries and stakeholders, communities and recipients of care and partnerships with local organizations and donor agencies. Organizational cultures need to be changed as well as local systems and infrastructure, including information systems that collect routine programme data that are both accessible and of high quality. With the current momentum towards high-quality health services and the quality call to action (413), it is time for a quality revolution and to scale up quality management efforts within HIV programmes. This is especially important in the context of universal health coverage and the United Nations High-level Meeting on Universal Health Coverage in September 2019, which included a key call for building high-quality health systems that people and communities trust, in accordance with the quality call for action (Fig. 7.10).

7.13. Procurement and supply management systems for HIV health products

Overview

This section provides operational guidance on procurement and supply management, with a focus on how procurement and supply management systems can respond to new recommendations in these guidelines. Comprehensive advice on the general management of procurement and supply management systems is readily available in existing publications and training materials. References to relevant publications and materials are provided at the end of this section.

The overarching objective of procurement and supply management systems is to support national policy with the adequate and continuous availability of the most effective, heat-stable, fixed-dose, quality-assured ARV drug formulations, diagnostics and other consumables at service delivery sites, in the right quantities, at the lowest possible cost, with the right remaining shelf life on delivery and in a timely manner.

All people living with HIV should be able to initiate ART regardless of clinical stage or CD4 cell count. This requires an integrated national strategic response that considers the resources available and enables strong procurement and supply management systems at all levels of the health system. In addition, the fact that all people living with HIV need to be receiving ART will accelerate the scale-up of ART programmes.

Implementation considerations

Challenges and opportunities associated with implementing WHO recommendations related to ARV drugs and diagnostics include:

  • product selection;
  • quantification and demand forecast;
  • the ability of global supply to cope with increasing global demand;
  • procurement planning and execution, including the timeliness of orders and delivery;
  • storage and distribution, including logistics constraints;
  • monitoring of consumption and demand changes;
  • frequency of ARV drug pickup and the flexible algorithm for multi-month dispensing (specific to ARV drugs);
  • information flow between stakeholders at different levels;
  • costs and opportunities for saving;
  • product shelf life;
  • risk of stock-outs if product procurement is unaligned with demand; and
  • risk of expired health products if the quantities procured have been overestimated.

These issues can be addressed through a national stakeholder working group that would develop a plan to address these issues, with participation that includes health policy-makers, implementers, funders, procurement and supply management specialists, central medical stores management and the finance ministry.

Selecting pharmaceutical and diagnostic products

  • Medicines and diagnostic products should be selected in accordance with national guidelines and programme needs.
  • National guidelines should provide guidance on using alternative regimens or diagnostic technologies in case of drug toxicity and treatment failure, infrastructural limitations and supply shortages, respectively, in accordance with the WHO recommendation.
  • WHO recommends that the overall number of regimens be minimized to optimize treatment and sourcing. According to WHO country surveys conducted in 2020, some countries are using more than 20 ARV drug regimens.
  • Before new products are included in national essential medicines and diagnostics lists, registration and intellectual property status should be verified to ensure that the product can be imported.
  • If a selected ARV drug or diagnostic is not on the national drug list and/or registered in the country, HIV programme managers should coordinate with the national regulatory authority and request that these commodities be put on the list and properly registered. Pharmaceutical and diagnostic companies have a responsibility to register products in countries where they market their products, and countries have the responsibility to ensure that products desired for procurement are registered.
  • To avoid confusion, drugs and diagnostics products no longer recommended by WHO for any ARV drug regimens and removed from the WHO List of Essential Medicines should be removed from the national ART guidelines and essential medicine lists, and plans should be made to transition people to more effective regimens using existing stocks as appropriate. Any remaining stock should be properly disposed of.
  • The synchronized introduction of new guidelines with forecasting, procurement and distribution planning will minimize waste associated with products that are being phased out as well as shortages of newly recommended products during the transition process or period.
  • Key performance indicators should be developed to monitor drug and diagnostic use as well as wastage and stock-outs.

National essential medicine lists should be optimized for ARV drug formulations for children following the detailed guidance on preferred products for children provided in The 2021 optimal formulary and limited-use list for antiretroviral drugs for children: policy brief (414).

Quantifying and forecasting demand

To determine the volume of products required to meet programme demand, procurement and supply management managers need to know:

  • the numbers of people receiving treatment, disaggregated by age group;
  • the regimens used by these people;
  • the proposed changes in regimens, if any;
  • the expected rate of scale-up of treatment: the increase in numbers of people receiving each regimen in a given period of time;
  • the number of rapid test kits required to identify people living with HIV in accordance with scale-up targets;
  • the forecasted uptake and continuation of PrEP (415);
  • the frequency of multi-month dispensing; and
  • which products are approved and registered for use in the country.

Similarly, for diagnostics key information would be useful for quantification and forecasting, including:

  • the number of people needing testing (separate quantifications will be necessary for each test type: CD4 to identify advanced HIV disease, infant diagnosis and viral load testing for people living with HIV receiving treatment);
  • the number of tests required for each population;
  • the specific test used for each population and at each health-care facility; and
  • the expected rate of scale-up of testing.

The process of quantification of needs can be highly complex. Best practices suggest that the quantification should be undertaken annually, projecting for at least two years, with a semiannual review to ascertain whether any significant upward or downward adjustments are required. Assuming that financial resources are available, procurement and supply management managers can then plan ahead and place long-term orders based on a staggered delivery algorithm while allowing sufficient flexibility to adjust for potential changes in the pace of scale-up, regimen switching and/or other unforeseen events affecting consumption.

When product volume demand for a specified period has been quantified, procurement managers should develop a supply plan that considers:

  • the months of stock currently available;
  • the existing orders yet to be fulfilled by vendors;
  • the budget available for new orders;
  • the volume of new products required to satisfy forecasted demand, including provision of a reasonable buffer stock; and
  • the required delivery dates for new shipments to avert stock-outs.

WHO recommends that the process of supply planning be undertaken semiannually to accommodate changes in demand and any delivery delays from suppliers.

Procurement

A uniform and harmonized procurement system is required to efficiently procure quality-assured, affordable ARV drugs and diagnostics. Procurement should be based on selection of appropriate products and forecasted needs, considering consumption, expanding services, phasing in and phasing out formulations and implementing new recommendations, including multi-month dispensing. Transparent procedures should be adopted to achieve best-value procurement and a quality assurance system should be implemented to procure, store and distribute quality-assured pharmaceuticals, diagnostics and other health products.

National procurement programmes should:

  • request that partners supporting the national HIV programme consolidate procurement and supply management systems to pool procurement for ARV drugs and diagnostics;
  • consider joining other pooled procurement mechanisms to access favourable prices negotiated by large buyers and donors to increase economies of scale and minimize the risk of long delivery times observed with small orders (second-line ART and ART for children);
  • conform with agreed specifications for selected products to ensure a common basis for procurement competition, quality assurance standards and any special needs such as packaging or identification, with special requirements likely leading to price increases;
  • use a competitive process to ensure value for money;
  • for commodities in regular and repeated demand, such as medicines and diagnostics, establish or access long-term framework-type contracts between large institutional buyers and manufacturers against which call-down orders can be placed, which will reduce procurement transaction costs and reduce the time elapsing between identifying the need and fulfilling the order and help to build collaborative relationships between buyers (national procurement managers) and sellers (suppliers);
  • wherever possible, implement a multi-supplier procurement strategy to support a healthy market and avoid dependence on a single supplier, which will also provide flexibility during periods of supply constraints or where individual suppliers face problems related to access to active pharmaceutical ingredients and key starting materials, in addition to manufacturing, production or logistical difficulties that may lead to delays;
  • use a publicly accessible database to facilitate access to information about prices and support competition; and
  • follow the principles described in the United Nations interagency guidelines for donated drugs and the WHO Model Quality Assurance System for Procurement (416).

National programmes should be aware that other countries and programmes will be ordering the same or similar formulations and tests, and manufacturers may already have existing orders that would account for the entirety of the manufacturing capacity, possibly for several months ahead. Working with their suppliers, procurement managers will be able to place their orders according to their required volumes and delivery schedules. Advice on manufacturer production capacity and any existing supply constraints and opportunities may also be available from the organizations and contacts provided at the end of this chapter.

Storage and distribution

Appropriate storage and distribution of HIV medicines, diagnostics and other commodities are essential. Recent recommendations that all people living with HIV should be able to start ART, preferably a DTG-containing regimen, take at least one viral load test per year per person, CD4 for staging of HIV advanced decease, increase the use of infant HIV diagnosis and implement the new multi-month dispensing model will significantly increase commodity volumes and the demands on storage and distribution throughout the supply chain and at the patient level. Countries will need to examine the appropriate level in the supply chain to hold stock, plan for new public facilities or examine alternative approaches, including leveraging additional resources by outsourcing to private sector facilities, provided that they are appropriate to store pharmaceuticals and diagnostics. Neither of these options is a quick fix; funds permitting, contracting with private sector providers may take many months to complete the appropriate tendering, contracting and quality assurance of providers before available facilities can be activated for use. Countries may also explore the potential of existing parallel systems, such as cold-chain facilities in immunization programme infrastructure for products that require temperature control.

Procurement and supply management systems should consider planned programmatic changes in service delivery related to the frequency and locations where people receive their ARV drugs. For example, community distribution of ARV drugs to people who are clinically stable and community-based HIV testing and ART start may involve another step in the local supply chain and potentially increase the quantity of ARV drugs and diagnostics to be procured and distributed. Changes that positively affect the amount of stock retained at each level, including by the client, need to consider the shelf life of the ARV drugs. For example, the most common first-line ARV drugs currently have a 36-month shelf life, and many rapid test kits have only a 12- to 18-month shelf life.

Storage and distribution plans should include:

  • quality assurance of products on receipt at the warehouse;
  • availability of secure storage facilities appropriate for pharmaceuticals and diagnostics;
  • cold storage for products that require temperature control;
  • rationalization of the number of storage levels to reduce the length of the supply pipeline;
  • inventory control systems with appropriate minimum and maximum levels that trigger reordering;
  • regular distribution patterns to service facilities, with increased frequency of potentially smaller deliveries supporting more effective use of existing limited space and distribution capacity;
  • routine data reporting from facilities to monitor usage and identify changes in predicted consumption patterns that may risk overstocks (which can be reallocated to avoid expiry) or stock-outs; and
  • a shelf-life management system.

Ensuring secure supply for programme flexibility and to avoid stock-outs and expired health products

Avoiding stock-outs is essential to prevent treatment discontinuation. Recommended actions to avoid the risk of stock-outs include the following.

  • Close coordination with programme managers and policy-makers is required to understand the planned progression towards the “treat all” targets. Programme managers and clinicians should agree on the speed at which new people will initiate treatment, how the treatment outcomes will be measured, how newborn babies will be screened and how people with advanced HIV disease will be assessed to ensure that the required commodities are available. A faster-than-necessary introduction of new people receiving ART will exhaust stocks and cause an increased risk of stock-outs, and a slower-than-planned introduction risks overstock and wastage because of expiry.
  • The supply chain implications of any recent or proposed changes in the service delivery model, such as multi-month dispensing or community distribution of ARV drugs, should be clearly understood.
  • Ensure that the ARV and diagnostics supply chain – especially its distribution system and allocation of commodities by facility – reflects the geography of the epidemic.
  • New recipients should initiate the preferred first-line regimen, unless clinically contraindicated.
  • Quantification and ordering should include a rotating safety buffer to compensate for errors in forecasting and potential delivery delays. It is recommended that the buffer be part of normal stock rotation, not a separate stockpile, to avoid the risk of retaining aged or expiring product. The level of buffer may vary but should cover at least one round of planned deliveries so that any delivery delay will not lead to a stock-out. Forecasts should be revisited at least semiannually to adjust for variance between forecasts and actual demand and to review demand for the next 12–18 months, adjusting orders as necessary.
  • Orders should be placed in a manner enabling timely delivery. Procurement managers should work closely with their suppliers to understand the suppliers’ normal delivery periods and plan accordingly. It is recommended that orders be placed at least 12 months ahead of the required date of delivery, since this will allow adequate time for production and – where volumes allow delivery by sea freight – reduce the cost of shipping. It is also recommended that, where practical, deliveries be staged rather than arriving as a large shipment for six months or more of stock. Staged deliveries enable more flexible delivery schedules and enable procurement and supply management managers to make the best use of existing storage and distribution capacity.
  • The procurement and supply management manager should also be aware of potential and actual constraints in the global market. In 2020, there were some constraints in the availability of important active pharmaceutical ingredients. This affected the ability of formulators to manufacture and deliver finished product on time, and, where possible, such inconveniences must be factored into requested delivery times when placing new orders.
  • Where possible, special consideration should be given to products with low demand, such as many drugs used by adults or adolescents receiving second- or third-line ART and many ART regimens for children and infant diagnosis. Production of these commodities will be less regular, and many countries only require low volumes, usually less than a full production batch. Pooled procurement at the national level and cooperation between countries and with suppliers may be appropriate for these products, and buffer stocks may need to be higher to compensate for less regular deliveries and challenges in accurately forecasting usage and uptake. Examples of such mechanisms include the PAHO regional drug facility and the Paediatric ARV Procurement Working Group. Countries can also consider placing orders through institutional mechanisms such as the Global Fund’s wambo.org platform, which assures the best prices and delivery times.
  • Where procurement regulations allow, it is recommended that framework contracts be placed to enable call-down orders. This maximizes the flexibility in delivery schedules that can be adapted to actual consumption and reduces the need for frequent repeat procurement and bidding exercises without compromising value for money.
  • Several of the above actions will limit the risks of stock-outs and expired products (such as moving ARV drugs from low-volume treatment sites to high-volume treatment sites). However, when expired products are identified, they should be destroyed according to approaches and various disposal methods outlined in the WHO Guidelines for safe disposal of unwanted pharmaceuticals in and after emergencies (417).

Use and monitoring

Robust information systems ensure the availability of accurate and timely consumption data on drugs and diagnostics and other information required for effectively monitoring the performance of the entire supply system and for forecasting the quantity of ARV drugs and diagnostics needed. Monitoring procurement and supply management by effectively using early warning indicators prevents stock-outs and overstocks, which could lead to expiry. Reliably capturing and analysing usage and consumption data from facilities will support a robust bottom-up approach to quantification and forecasting that will reflect changes in demand and support a flexible approach to introducing new recommendations in these guidelines.

Special considerations for ART regimens for adults

Four key challenges for the supply chain arise as a result of the current recommended ARV drug regimens.

  • The currently approved suppliers of fixed-dose combination formulations of TLD are expected to have sufficient production capacity to satisfy the increased demand for these formulations as the numbers of people on treatment increase if increases are carefully phased to avoid sudden spikes in demand. However, short-term supply constraints may arise, highlighting the need for efficiently planning, maintaining and managing buffer stocks at the national level.
  • Delivery lead times for the recommended first-line medicines may become extended during peak periods of demand. Procurement and supply management managers should be aware of current lead times and plan their orders and deliveries accordingly.
  • Purchasers and implementing partners who are distributing TLE-, TEE-, AZT- and EFV-based regimens to users and have stocks and orders in process should consider how they manage their stocks to avoid stock-outs or wastage from expiry of usable products from overstocks.
  • Where demand for certain regimens is limited, pooling orders from several buyers is recommended to increase the volumes to be ordered and to ensure that suppliers can deliver and adequately respond to the demand.

Transitioning to recommended preferred regimens and preferred formulations

Programmes should plan carefully and discuss with their suppliers the pace at which increased quantities of TDF- and DTG-based products can be made available. To ensure that supply is available to meet anticipated demand, a phased programme is highly recommended. The following approaches are suggested.

  • Initiate new people living with HIV eligible for ART on DTG-based regimens, with preference for the fixed-dose combinations of TLD.
  • Include buffer stocks in supply plans and liaise closely with suppliers, global public sector procurement platforms and the major pooled procurement mechanisms to understand global demand patterns and act accordingly.

Programmes should stop procuring the following.

  • d4T, ddI, FPV, IDV, NFV, NVP and SQV should no longer be procured since these are no longer recommended as an alternative NRTI or PI in first or second-line regimens for adults or adolescents because of toxicity, lower efficacy and inconvenient dosing requirements.

People currently receiving first-line AZT- and/or NVP-based regimens should be transitioned to TLD, TLE 400 mg if they cannot tolerate DTG.

In areas with a high prevalence of HIV-2 infection, procuring and using formulations with two-drug fixed-dose combinations (TDF with 3TC, TDF with FTC and AZT with 3TC (in second-line ART) might be a preferred option, since this provides flexibility to combine the NRTI backbone with PIs or INSTIs in first- and second-line therapy for people living with HIV-2 infection.

In the case of newer products such as DTG, DRV and RAL for children or existing products with low demand (such as for second- or third-line regimens), where feasible and practicable, procurement managers should consider pooling their demand with other domestic programmes, neighbouring countries, other regional programmes and/or collaborating with major purchasers to form a part of total orders that meet manufacturers’ production batch sizes. Shelf life, storage facilities and consumption patterns permitting, procurement and supply management managers should also plan to hold larger buffer stocks for essential products in low demand. For newly introduced products, initial orders requiring longer lead times should also be assumed.

Supply chain considerations for implementing less frequent ARV drug refills, community ART delivery and lay health-care providers distributing ARV drugs

Programme managers and policy-makers need to consider several supply chain issues when implementing recommendations regarding less frequent ARV drug pickups and/or using community ART delivery service delivery models and lay health-care providers distributing ARV drugs. Procurement and supply managers and policy-makers should examine the current ARV drug supply chain model and its performance to determine the adaptations needed to enable the supply chain to support the achievement of these recommendations. Since one-size-fits-all supply approaches will not meet the needs of differentiated care models, the local supply chain must be agile enough to serve a variety of service delivery models, including at the community level. In addition, programme managers should consider taking a phased approach that considers:

  • the additional ARV drugs needed at facility or pickup sites, including providing a safety buffer stock;
  • the total number of people to be served by multi-month (3–6 months) prescribing and the regimens they currently use;
  • the capacity of local distribution sites to safely, optimally and securely store and manage the additional ARV drugs;
  • the additional reporting needed by the logistics information system to track the ARV drugs through these sites, including at the community level;
  • any ARV drug shelf-life constraints;
  • the overall performance of the supply chain in which the recommendations will be implemented; and
  • incorporating additional ARV drug requirements in the country’s annual quantification, funding, procurement and supply plans.

Besides the quantity of additional products initially required to implement these recommendations, the manufacturing capacity and lead time may influence the pace at which programmes can take new recommendations to national scale.

Special considerations for ART for children

Given the continuing challenges of ensuring the availability of ARV drug formulations for children, WHO and partners provide guidance on optimal ARV drug products for children to promote a secure and sustainable supply. The group met in December 2020 to revise and update the Optimal Formulary (414). The sixth edition of the Optimal Formulary (Table 7.3) and Limited-use List (Table 7.4) is intended to support the transition and implementation of preferred and alternative ART regimens recommended for infants and children in WHO guidelines across all lines of treatment.

Table 7.3. Optimal Formulary.

Table 7.3

Optimal Formulary. Minimum number of ARV drug formulations needed to provide all currently WHOrecommended preferred and alternative first- and second-line ART options for infants and children and infant prophylaxis for preventing the vertical transmission (more...)

Table 7.4. Limited-use List.

Table 7.4

Limited-use List. ARV drug formulations that are included in the WHO guidelines and are needed for a limited time or in low volumes

To ensure smooth implementation of recommended first-line regimens for children, it is critical for policy-makers and implementers to consider the availability of ARV formulations for children. National programmes are urged to limit the procurement of ARV drug products for children to formulations on the Optimal paediatric Formulary. Complying with the ARV drug Optimal Formulary – which is based on WHO recommendations – will help to simplify the supply chain and aggregate global demand to stabilize the global supply of ARV drugs for children.

Funding agencies, procurement entities, manufacturers, national medicine regulatory authorities and national governments all have a critical role to play in working together to ensure the availability of products on the Optimal Formulary and Limited-use List, which can be achieved by fast-tracking in-country registration, maintaining procurement and supply-chain planning, facilitating commercialization, ensuring manufacturing capacity and filing applications for registration in other countries. Having one or more quality-assured suppliers available at the national level is a criterion for selection of products.

Specific consideration for treatment and procurement for children

When available, age-appropriate fixed-dose combinations for any recommended regimen are preferable.

Dispersible tablets (or granules for oral solution) are preferred formulations for children because tablets or granules can be made into liquid when administering the drug to the child. If suitable dispersible formulations are not available and oral liquids must be used, it is recommended that children be switched to a solid oral dosage form (such as granules, pellets or dispersible tablets) as soon as possible.

Administering ART to neonates generally requires oral liquid formulations, and switching to solid oral dosage form as soon as possible is recommended (for example switch from RAL or NVP to DTG 10 mg scored dispersible tablets at four weeks of age).

Scored tablets are preferred to ensure accurate dosing. Splitting unscored tablets should be avoided since uniform distribution of active drug product cannot be assured and the bioavailability of the drug within the body may be decreased.

Oral liquid formulations should be avoided in favour of solid oral dosage forms when available.

For further guidance to support the transition to new formulations for children see tools and policy briefs in the AIDS free toolkit (348).

Checklist for introducing new products and phasing out old ones

Introduction of new medicinal or diagnostic products is one of the most complex and unpredictable activities in any HIV programme and as such presents a heightened challenge for policy-makers, procurement and supply management managers and manufacturers. When planning the introduction of new products, the following procurement and supply management-related factors should be considered.

Is the product subject to patent or other intellectual property protection that would restrict access to generic formulations of the product in your country? Access to generic versions of ARV drugs is restricted in many middle-income countries. If this is the case, advice is available from WHO (418).

Is the product registered for use in your country? If not, consider obtaining a temporary waiver and in the meantime accelerate the official registration processes for future procurement. This information should be available from the national regulatory authority. Although the manufacturer is responsible to arrange registration, registering a drug in all countries can be a lengthy and expensive process.

What is the forecasted demand for the product, including the anticipated pace of adoption? The pace of adoption is very difficult to forecast accurately, and ordering and delivery schedules must consider this unpredictability. More rapid adoption may lead to stock-outs if the procurement plan did not consider this, whereas a slower pace could lead to expiry of stocks if the procurement plan assumed faster adoption. Procurement and supply management managers need to monitor consumption closely and have risk mitigation strategies in place. If adoption is more rapid, suppliers should be asked to be prepared to respond to urgent orders. If adoption is slower, suppliers should be asked to deliver quantities gradually according to country requests until all the quantities ordered are consumed. Ordering in large volumes has the advantage of economies of scale, but suppliers should be flexible enough to send deliveries according to national demand to prevent expiry and wastage. Procurement and supply management managers are encouraged to work with HIV programme managers in formulating risk mitigation plans to account for the difficulty of accurate forecasting of demand and the pace of adoption.

How will introducing the new product affect the use of existing medicines or diagnostics? Unless it is recommended that a product be stopped because of severe toxicity or other reasons, procurement and supply management managers should always plan to optimize use of existing stocks and orders before completely switching to new products to avoid wastage.

How will purchasing the new product affect procurement budgets? Procurement and supply management managers may consult major global buyers and others to gauge the expected price so that quantities of existing and new products can be accommodated within the available budget. In some cases, lack of sufficient funds has delayed a full transition to new products that were more expensive or led to stock-outs of existing products.

What is the shelf life of the product and how might this affect the procurement strategy and the in-country distribution of the product?

Does the new product require any special handling or storage, such as temperature control? Consider adjusting the capacity and storage conditions of current facilities.

What is the production status of the new product? What minimum order will the supplier accept, and what is the anticipated lead time from order placement to delivery? For products in lower demand, manufacturers may only be willing to commit to production once they are assured of commercially viable orders.

If small volumes of new products are required, procurement and supply management managers should consider collaborating with neighbouring countries or global pooled procurement mechanisms to reach total order volumes that are viable for the manufacturers. This strategy may be particularly appropriate for second- and third-line formulations and for ARV drugs for children.

Policy-makers and procurement and supply management managers may consult global buyers and other knowledgeable entities to gain market intelligence on new formulations while they develop strategies to introduce these new formulations through national procurement.

Points to consider for setting the remaining shelf life of medical products on delivery (419)

Decisions on remaining shelf life for medical products should be defined realistically, contextualized and adapted to each importer, following thorough risk assessment considering the criteria below. It should be defined and be based on relevant factors, including but not limited to the category and type of product; inventory level; manufacturing and transit lead time; local release lead time; storage condition; delivery chain; and resources in the recipient country or region.

Suppliers, purchasers and recipients should make agreements covering the relevant responsibilities of each party, including remaining shelf life or expiry date.

Products should be transported, received, stored and distributed in accordance with WHO good storage and distribution practices (420). Special attention should be given to products sensitive to temperature, light and moisture.

Products supplied by the manufacturer or supplier should comply with the policy of the national government and the recommendations on remaining shelf life prescribed here.

Products should be appropriately labelled. The label should include the expiry, retest or install by date, as appropriate.

The products received should be scrutinized in an attempt to identify possible substandard and falsified products. For example, ensure that the expiry date is not falsified (421).

If different periods for remaining shelf life have been defined for products, recipients should ensure that the products meet the remaining shelf-life requirement for the intended destination, such as a central warehouse, regional warehouse, testing site or user point.

National authorization for importation, if required, should be obtained based on the available information, including the expiry date of the product, to enable the remaining shelf life to be calculated and to assist in expediting approval.

When justified, suppliers, recipients and national authorities may negotiate deviations from the policy for remaining shelf life. If the remaining shelf life is shorter than stipulated in the policy, ensure that the stock will be consumed before expiry and that the medical product reaches end-users with adequate remaining shelf life to permit confidence on the time to consume it before expiry.

Risk should be assessed with the following considerations to ensure that the parameters listed above are met:

  • assessment of need;
  • type of product: different implications in terms of patient safety with respect to pharmaceutical products, vaccines, medical devices and in vitro diagnostic products;
  • expiry date: with this, the remaining shelf life at delivery time can be estimated;
  • compliance with WHO guidelines on good storage and distribution practices (418);
  • delivery time to storage facility;
  • storage conditions;
  • stock rotation;
  • delivery time from storage to end-user;
  • frequency of stock replenishment – order frequency (based on consumption): recipients and end-users should regularly verify that medical products in stock are rotated or used within their remaining shelf life and adjust the quantities ordered to ensure that the medical products will be used within their remaining shelf life;
  • assessment of the real needs, to ensure that the medical products can be used within their shelf life;
  • emergencies: during an emergency situation, the policy on remaining shelf life should be well balanced to ensure that life-saving medical products will be received on time and that the needs will be covered if there is increased demand;
  • logistic set-up: the location of the premises, the number of means and types of transport and the number of vehicles and their adaptability will affect the speed of delivery and therefore the confidence that products will be used before their expiry date; and
  • activity specificities: similarly, whether the medical products will be used by the national programme or are managed directly by the importer outside of a national programme will make a difference in terms of speed of delivery to the end-user. The point of delivery – national warehouses or importer or end-user facilities – will also affect the speed of delivery.

Useful procurement and supply management resources

This document does not cover all technical issues related to supply chain management. The Procurement & Supply Management Toolbox (422) contains procurement and supply management tools that can be searched by technical area and by publishing organization.

7.14. Laboratory and diagnostic services

Overview

Implementing the recommendations in these guidelines will require increased access to laboratory and diagnostic services.

To ensure that diagnostic services are accurate and reliable, relevant quality assurance systems need to be developed and strengthened. Within a country, a multiplicity of diagnostic settings may exist, such as laboratories, maternal and child health clinics, HIV testing and counselling sites and community-based testing. A multipronged and networked approach to selecting diagnostics and laboratory systems should therefore be planned and adopted. Because many new diagnostic tests and point-of-care systems are entering the market, the use of only high-quality diagnostics and equipment needs to be ensured. Strategic planning for proper placement and harmonization of testing platforms should be carried out to ensure appropriate use and cost–effectiveness.

Effective laboratory and diagnostic services require sound leadership and governance to enable the following activities (423):

  • strengthening and expanding laboratory and diagnostic services;
  • supporting a dedicated specimen referral system;
  • increasing access to HIV diagnostics, including infant diagnosis, CD4 and viral load testing;
  • supporting the expansion of diagnostic services to include testing at the point of care;
  • training and certifying health-care workers who perform testing; and
  • ensuring high-quality diagnostics and plans for implementation, including quality assurance.

WHO and the United States Centers for Disease Control and Prevention have developed a guidance handbook on quality assurance approaches for point-of-care tests and laboratories in low- and middle- income countries (Fig. 7.10) (424).

Fig. 7.10. Three phases of diagnostic quality assurance.

Fig. 7.10

Three phases of diagnostic quality assurance.

Strengthening and expanding laboratory and diagnostic services

The following areas are important to strengthen the network of laboratory and diagnostic services for implementing the recommendations in these guidelines:

  • national laboratory strategic plans and policies;
  • reviewing available diagnostics for their performance and operational characteristics to select optimal products before introduction;
  • carrying out strategic planning and diagnostic network optimization for properly placing and harmonizing testing platforms to ensure appropriate use and cost–effectiveness;
  • expanding current diagnostic networks to support and monitor expanded access as well as decentralization and integration of testing and diagnostic services;
  • allocating appropriate resources to ensure the availability of diagnostic tests, including human and financial resources, and
  • guidance on operations and service delivery.

Supporting a dedicated specimen referral system

When point-of-care testing is unavailable, laboratory referral systems and procedures for collecting and processing specimens need to be strengthened to increase access to viral load testing and other testing needs. Providing for and strengthening an integrated, efficient, safe and cost-effective specimen referral system requires reliable specimen transport with adequate conditions for whole blood, plasma, dried blood spot specimens and other potential alternative specimen types that rapidly and dependably reports test results back to the referring site with linkage to care. Integrating specimen referral systems across diseases may be a beneficial consideration to leverage those already in use and create system efficiency across programmes.

Increasing access to HIV diagnostics

These guidelines recommend the use of several HIV diagnostics including infant diagnosis, CD4 and viral load testing. This will require ongoing strengthening of existing diagnostic services and phased expansion of monitoring services in peripheral facilities. It may involve:

  • strengthening, leveraging and integrating diagnostics within existing networks;
  • ensuring that health-care facilities and laboratories have adequate infrastructure, human resources, technical expertise, service and maintenance programmes, quality assurance mechanisms including supervision and monitoring of supply chain management and quality improvement programmes; and
  • ensuring the optimization of high-volume centralized laboratory testing and testing at the point of care across all testing needs, giving priority to the people most at risk for morbidity and mortality.

Table 7.5. Tiered laboratory network at various levels of the health-care delivery system.

Table 7.5

Tiered laboratory network at various levels of the health-care delivery system.

7.15. Laboratory connectivity

Recommendation (2016)

Electronic communication can be considered to transfer test results and reduce delays in acting on the results of infant diagnosis and other essential laboratory tests (conditional recommendation, low-certainty evidence).

Source: Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach – second edition (3)

The decentralization of HIV care to lower levels of the health system has enabled expanded access to treatment and improved outcomes. One challenge to delivering care at peripheral facilities has been to ensure the rapid and reliable turnaround of laboratory results. Lack of efficient sample transport systems can result in delays in or losses of results, which in turn can delay clinical decision-making.

Although this can be partly overcome by using technologies such as point-of-care devices or rapid tests that provide results on the same day as specimen collection, if these are unavailable, alternative approaches are needed to minimize delays in turnaround time of essential laboratory results, especially for infant diagnosis. SMS/GSM/GPRS printers represent a potential solution, whereby laboratories can transmit SMS/GSM/GPRS-based messages to the clinic site in real time via standard telecommunication networks. Several countries have well-established programmes using SMS/GSM/GPRS printers, including Kenya, Mozambique, Rwanda, South Africa, Zambia and Zimbabwe. Several other countries are in the implementation and pilot phases of SMS/GSM/GPRS printer use.

Rationale and supporting evidence

A systematic review was conducted focusing on the potential for electronic systems for delivering results to reduce the turnaround time of early infant HIV diagnostic test results (425). Mortality among infants living with HIV is highest during the first three months, and early HIV diagnosis and early ART can significantly reduce this risk (426). Turnaround times using traditional paper-based systems can extend to about two months, leading to loss to follow-up of mothers and their infants and increased infant mortality if treatment is delayed.

The review identified 11 studies, all from Africa, and found that the use of SMS/GPRS printers reduced the average turnaround time by 17 days (from 68 to 51 days), with several studies reporting a turnaround time of less than 20 days. The evidence was rated as low quality because of the absence of randomized study designs and lack of data on clinical impact. Because similar efficiency could possibly be obtained for other laboratory results, electronic systems for delivering results could be used for other tests such as CD4 count testing, viral load testing and other non-HIV-related testing.

Cost

No formal cost–effectiveness analysis was conducted. However, the Guideline Development Group judged that the cost of the intervention would be offset by the substantial health benefits related to earlier identification of HIV-positive infants.

Equity

The technology aims to improve access to results in rural settings and, as such, the Guideline Development Group judged that it would improve equity.

Feasibility

Feasibility has already been demonstrated by applying SMS/GMS/GPRS printers in a variety of settings.

Implementation considerations

Adequate cellular phone network coverage, maintenance, troubleshooting and systems for ensuring a supply of sufficient credit and printer consumables are all key to ensuring coverage and uninterrupted service.

Implementation should consider the need to ensure data security and patient confidentiality.

Research gaps

Further studies should assess the clinical impact of SMS/GSM/GPRS printers on loss to follow-up, mortality and morbidity. It would be useful to assess the utility and impact of using SMS/GSM/GPRS printers and results return technologies for returning a range of laboratory results.

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