HIV Counseling and Testing
• PEPFAR’s efforts have led to a considerable achievement in increasing the availability of and access to HIV testing, counseling, and diagnosis. As a result, many more individuals have learned their HIV status and, if positive, been linked to clinical services. However, challenges remain in achieving adequate coverage of testing services, especially in scaling up and improving access to testing for infants and children and testing for pregnant women who do not attend antenatal care or deliver in health facilities. For those who test positive, challenges also remain in consistently ensuring they are linked to care and treatment as well as to prevention services to reduce HIV transmission. Overcoming these challenges and continuing to make progress in HIV counseling and testing will be a critical factor in achieving a successful comprehensive response to HIV.
HIV Care and Treatment Services
• PEPFAR has made a major contribution to increasing the number of people living with HIV who are in care and on antiretroviral therapy (ART) through the expansion of the number and geographic distribution of care and treatment sites, the training of providers, the procurement and delivery of drugs, improvements in laboratory services, and support for the adoption and implementation of national policies and guidelines in partner countries. Support for care and treatment programs is a success that has contributed to saving lives and improving the quality of life for people living with HIV in PEPFAR partner countries.
• Retention and adherence are critical and persistent challenges in PEPFAR-supported HIV care and treatment programs. Understanding the factors that contribute to the lack of retention and the most effective strategies to improve it is needed to fully maximize the role of care and treatment in a sustainable HIV/AIDS response.
• PEPFAR has made a tremendous contribution to a wide variety of clinical and nonclinical care and support services, beyond the provision of antiretroviral therapy, through scale-up of services and programs in facilities and communities and through support for partner country policies, guidelines, and protocols. However, in the area of nonclinical care and support in particular, services span a diffuse range of activities across countries and it is difficult to assess their effects. Information is lacking on the distribution of services, the intended outcomes, how well the services are matched to population and subpopulation needs, and the effectiveness of these services.
• The particular importance of efforts to address HIV and tuberculosis (TB) is well-recognized within PEPFAR and in partner countries, given that TB is a common co-infection and a leading cause of death for people living with HIV. PEPFAR has increasingly supported the integration and coordination of screening, diagnosis, and referrals or other linkages to treatment for both infections. PEPFAR has also made a notable contribution in its support for advancing policies and systems for TB/HIV integration in partner countries. However, progress in this area has come more slowly than in other clinical services for HIV, and challenges persist in achieving adequate coverage of both HIV screening for TB patients and TB screening for HIV patients, as well as in ensuring and monitoring subsequent referral and retention in treatment for both infections. Concerted efforts in this area will be critical for reducing mortality from TB/HIV as part of an effective response to HIV.
• The expansion of treatment has an ancillary effect of increasing drug resistance. The earlier that ART programs were implemented in a region, the more drug resistance is present. Because of the limited availability of second-line antiretroviral drugs in resource-limited settings, as drug resistance increases, the need for an expanded pharmaceutical arsenal for effective treatment intensifies. The emergence of HIV drug resistance is cause for greater efforts to improve the effectiveness and expand the implementation of adherence support, treatment failure and drug resistance monitoring strategies, and treatment options in resource-limited settings.
• The ability to assess the impact of PEPFAR-supported care and treatment programs across countries and partners is restricted by limitations in the available data. The available program-wide output measures provide a sense of the growth of PEPFAR-supported treatment programs over time but do not provide an understanding of the distribution of those services in populations of interest and do not provide measures of effectiveness and outcomes. It was a missed opportunity not to invest more resources earlier in standardized, realistic, and useful monitoring of outcomes.
Ongoing Challenge of Coverage
• Despite progress in the availability of and access to HIV services, there remains a large unmet need for care and treatment in PEPFAR partner countries. Intrinsic limitations of the health system infrastructure and other systems involved in the response continue to pose barriers to the delivery of care and treatment services, including nonclinical care, clinical care, clinical and laboratory monitoring, and antiretroviral therapy.
• Treatment of infants and children remains a persistent challenge across the continuum of care. The main barriers, especially for infants, come at the stages of testing and diagnosis, linkages to care and treatment, and timely initiation of therapy. Limitations in health systems for support of pediatric HIV services are also a major factor. PEPFAR has contributed to increasing pediatric treatment, but the coverage of pediatric HIV remains proportionally much lower than the coverage for adults, despite the goal in the reauthorization legislation to provide care and treatment services in partner countries to children in proportion to their percentage within the HIV-infected population.
Sustainability of HIV Treatment
• A fundamental challenge for the sustainability of care and treatment across PEPFAR partner countries is how to maintain those currently enrolled in care and treatment, address the care and treatment needs for the many currently eligible patients who are not yet enrolled, and plan for those who will become eligible in the future, especially as changing World Health Organization (WHO) guidelines are adopted and implemented. There is a critical need for PEPFAR to work with partner countries and other global partners to sustain the gains made, to continue to make progress in achieving greater coverage, and to ensure the ongoing quality of services provided and programs implemented. Given the realities of resource constraints and the possible flattening or decreasing of external resources, contributing stakeholders will need to allocate resources with a strategic and ethical balance among coverage priorities.
Recommendations Presented in This Chapter
Recommendation 6-1: To improve the implementation and assessment of nonclinical care and support programs for adults and children, including programs for orphans and vulnerable children,1 the Office of the U.S. Global AIDS Coordinator should shift its guidance from specifying allowable activities to instead specifying a limited number of key outcomes. The guidance should permit country programs to select priori-
1The discussion of programs for orphans and vulnerable children leading to this aspect of this recommendation can be found in Chapter 7.
tized outcomes to inform the selection, design, and implementation of their activities. The guidance should also specify how to measure and monitor the key outcomes.
Further considerations for implementing this recommendation:
• Outcomes for consideration should reflect the aims of care and support programs, which are to optimize quality of life, promote health, slow the progression of AIDS, and reduce HIV-related complications and mortality. Other outcomes of importance for the performance and effectiveness of care and support programs include measures of quality of services and equitable access to services.
• PEPFAR U.S. mission teams should work with partner country stakeholders and implementers to assess country-specific needs and to select a subset of the core key outcomes to focus on when planning, selecting, and developing evidence-informed activities and programs for implementation.
• The Office of the U.S. Global AIDS Coordinator (OGAC) should provide general guidance for country programs on continuous program evaluation and quality improvement to help them measure and monitor achievement of the key outcomes. This guidance may include, for example, template evaluation plans and methodological guidance. To allow for comparability across countries and programs, evaluation plans should include (but not be limited to) the defined indicators or other measures of the core key outcomes. Evaluations should emphasize the use of in-country local expertise (e.g., local implementing partners and subpartners and local academic institutions) to enhance capacity building and contribute to country ownership. (See also recommendations for PEPFAR’s knowledge management in Chapter 11.)
• PEPFAR should develop a system for active dissemination and sharing of evaluation outcomes and best practices both within and across countries that is driven as much by country-identified needs for information as by opportunities for exchange of information identified by headquarters-level leadership and technical working groups. (See also recommendations for PEPFAR’s knowledge management in Chapter 11.)
Recommendation 6-2: To contribute to sustainable care and treatment programs in partner countries, PEPFAR should build on its experience and support efforts to develop, implement, and scale up more effective and efficient facility- and community-based service delivery models for the continuum of adult and pediatric testing, care, and treatment. These efforts should aim to enhance equitable access, improve retention, increase clinical and laboratory monitoring, ensure quality, and implement cost efficiencies.
Further considerations for implementation of this recommendation:
• This recommendation should be implemented in coordination with recommendations and considerations discussed in Chapter 9 on health systems strengthening.
• PEPFAR should develop a system for active dissemination and sharing of best practices in service delivery both within and across countries. (See also recommendations for PEPFAR’s knowledge management in Chapter 11.)
Recommendation 6-3: To assess PEPFAR-supported HIV care and treatment programs and to evaluate new service delivery models, the Office of the U.S. Global AIDS Coordinator should support an enhanced, nested program monitoring effort in which additional longitudinal data on core outcomes for HIV-positive adults and children enrolled in care and treatment are collected and centrally reported from a coordinated representative sample across multiple countries and implementing partners.
Further considerations for implementation of this recommendation:
• This activity would serve as a targeted, nested evaluation within routine program monitoring systems to allow for long-term operational assessment of performance and outcomes for care and treatment across a representative sample of PEPFAR-supported programs. The aim would be to focus on key areas for evaluation and improvement of programs going forward, including as PEPFAR supports innovations in service delivery and as PEPFAR-supported programs transition to new models of implementation.
• Data collected and reported for this sample should be harmonized with existing data collection whenever possible, including data already collected by implementing partners but not centrally reported (e.g., see the discussion of Tier 3 data in the implementation considerations for Recommendation 11-1A). Collaborative opportunities may be feasible with existing or new large-scale national and multi-country samples.
• This data-collection effort should be designed by first identifying and prioritizing the key questions that require longitudinal data and then focusing on relevant key outcomes with measures that are standardized across the sample. Priorities should include core outcomes related to clinical care and treatment, including adherence and retention; outcomes related to the reduction of HIV transmission through biomedical and behavioral prevention interventions for people living with HIV; quality measures; and program measures, such as the costs of services, that can help inform strategies for efficiencies, sustainable management, and resource planning for the trajectory of need.
• There may also be opportunities for an established data collection effort of this kind to serve as a synergistic platform for targeted implementation research studies in subset samples to assess innovations and advance those best practices that are most ready for translation and scale-up.
• In addition to implementing this approach prospectively, OGAC should explore working with and coordinating Track 1.0 partners to pool data for retrospective outcome analyses.