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 (5–8), 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:
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:
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 (). 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
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 (33–35). 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 (27,36–39). 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 (53–56). 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 (65–67). 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:
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.
7.8. 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 (191–194).
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.
7.10. 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 (257–263)
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 (264–266)
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 (267–273)
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 (274–277)
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 (). 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.
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:
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 (288–290).
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.
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.
7.12. 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 (389–391) 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 ().
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).
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 () (3).
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 ().
Eight core elements to produce a national quality policy and strategy.
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.
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 ().
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 ().
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 ().
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.
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 () and Limited-use List () 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.
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...)
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.
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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).
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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.
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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.
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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.
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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.
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What is the shelf life of the product and how might this affect the procurement strategy and the in-country distribution of the product?
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Does the new product require any special handling or storage, such as temperature control? Consider adjusting the capacity and storage conditions of current facilities.
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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.
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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.
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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.
7.15. 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.