Scaling Up HIV Programs

PEPFAR has provided a “proof of principle” that HIV services can be successfully delivered on a large scale in countries with a high burden of disease and limited available resources and infrastructure.

PEPFAR has increased the availability of and access to HIV testing, counseling, and diagnosis; as a result, many individuals have learned their HIV status. PEPFAR has also made it possible for an increasing number of adults and children living with HIV to receive clinical care and treatment, including antiretroviral therapy, through an expansion of the number and geographic distribution of clinical care and treatment sites, training and support for providers, procurement and delivery of drugs, improvements in laboratory services, and support for the adoption and implementation of national policies and guidelines in partner countries.

Despite such remarkable and substantial progress, ongoing challenges across the continuum of clinical care and treatment services must be addressed to achieve positive health outcomes for people living with HIV and to ensure that care and treatment programs are contributing to a sustainable HIV response. One critical need is to improve linkages from HIV counseling and testing to care and treatment and also to prevention services aimed at reducing HIV transmission. Another essential need is to improve retention and adherence among patients in care and treatment.

In addition to clinical care and treatment services, PEPFAR has also supported nonclinical care and support services for adults and has provided unprecedented support for programs for orphans and vulnerable children infected with or affected by HIV. However, these services span a diffuse array of activities and often lack the strategic development in program portfolios necessary to maximize contributions to defined outcomes.

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. (Chapter 6)

To assess PEPFAR-supported HIV care and treatment programs and to evaluate new service delivery models, the Office of the U.S. Global AIDS Coordinator⁵ 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. (Chapter 6)

This effort would serve as a 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 the assessment and improvement of programs as PEPFAR supports innovations in service delivery and transitions to new models of implementation. Data collected and reported for this sample should be harmonized with existing data collection whenever possible. Priorities for longitudinal assessment should include quality measures; core outcomes related to clinical care and treatment, including those in key challenge areas such as adherence and retention; and outcomes related to the reduction of HIV transmission through biomedical and behavioral prevention interventions for people living with HIV. Program measures, such as service costs, that can provide valuable information to identify efficiencies and promote sustainable management should also be included.

To improve the implementation and assessment of nonclinical care and support programs for adults and children, including programs for orphans and vulnerable children, 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 prioritized outcomes to inform the selection, design, and implementation of their activities. The guidance should also specify how to measure and monitor the key outcomes. (Chapters 6 and 7)

To enable this shift to a more outcomes-oriented approach, partner countries will need support and assistance to prioritize outcomes and target services. For orphans and vulnerable children in particular, PEPFAR should improve the targeted coverage and quality of services by more explicitly and narrowly defining eligibility for PEPFAR-supported services at the country program level based on country-specific assessments of needs.

While services for people living with HIV are one foundation for the sustainable management of an HIV response, prevention is also paramount as part of a balanced attempt to change the trajectory of the HIV epidemic. PEPFAR's support for the scale-up of HIV prevention activities has been a valuable contribution to the HIV response in partner countries. PEPFAR has become more flexible over time in its approach to prevention, shifting from required budgetary allocations for specific intervention approaches to enabling the activities it supports to be tailored according to a country's epidemiological information and the available evidence for intervention effectiveness. As a result, PEPFAR's prevention programming has evolved from a limited number of behavioral and biomedical interventions initially to a greatly expanded portfolio of supported interventions based on existing and emergent evidence. A notable and measurable success in prevention has come in the area of the prevention of mother-to-child transmission, in which PEPFAR support has made a major contribution toward meeting the needs of partner countries.

Targeting the specific populations that are vulnerable to HIV infection and transmission, which differ by country, is critical for prevention. Notwithstanding some restrictive U.S. and partner country policy and legal environments, PEPFAR has made progress in this area through its support for data collection in specific populations and for prevention and harm reduction programming; these efforts have resulted in positive effects for populations at elevated risk, including men who have sex with men, people who engage in sex work, people who inject drugs, and other populations identified as vulnerable. Populations at elevated risk remain an important focus for prevention programming, and they also continue to struggle with barriers to accessing care and treatment services.

PEPFAR has stated its ongoing commitment to overarching goals for prevention. However, PEPFAR lacks clear objectives for outcomes across all types of prevention interventions. Achieving measurable intermediate outcomes for prevention efforts is important for PEPFAR to achieve its goals for reducing HIV transmission. However, there are limitations, not unique to PEPFAR, in the methods for appropriately measuring the outcomes of prevention interventions and in the available evidence for effectiveness for some types of intervention. These challenges are particularly salient for behavioral and structural interventions, especially for the prevention of sexual transmission, the primary global driver of HIV infection. An effective response requires responsiveness not only to the available evidence on intervention effectiveness, but also to the epidemiological evidence about the drivers of the epidemic. Given that behavioral and structural drivers will not be addressed through biomedical approaches alone, PEPFAR can contribute to a more effective HIV response by serving as a platform for innovation to help fill this gap in the availability of effective interventions and of appropriate approaches to assess prevention interventions. This would allow for a more balanced and comprehensive operational approach to developing, implementing, and evaluating prevention portfolios that are aligned with the drivers of epidemics and the needs for prevention services.

To contribute to the sustainable management of the HIV epidemic in partner countries, PEPFAR should support a stronger emphasis on prevention. The prevention response should prioritize the reduction of sexual transmission, which is the primary driver of most HIV infections, while maintaining support for interventions targeted at other modes of transmission. The response should incorporate an approach balanced among biomedical, behavioral, and structural interventions that is informed by epidemiological data and intervention effectiveness evidence. PEPFAR should support advances in prevention science to expand the availability of effective interventions where knowledge is lacking. (Chapter 5)

PEPFAR has articulated overarching aims for addressing gender-related factors that influence the HIV epidemic and response. In particular, PEPFAR has placed a strong emphasis on addressing gender-based violence, an important underlying driver of vulnerability in the HIV epidemic. PEPFAR's efforts have evolved from a focus on the HIV-related needs and vulnerabilities of women and girls to a more comprehensive focus that aims to also address the vulnerabilities of men and boys that arise as a result of social and cultural norms in partner countries about gender and sexuality. PEPFAR's gender efforts have scaled up slowly over time, in an ad hoc fashion, with little strategic guidance to facilitate comprehensive country portfolios that address gender norms and inequities and that incorporate gender-focused objectives within prevention, care, and treatment programs to improve service access, coverage, and quality for both men and women.

To achieve PEPFAR's stated aim of addressing gender norms and inequities as a way to reduce HIV risk and increase access to HIV services, the Office of the U.S. Global AIDS Coordinator (OGAC) should develop and clearly state objectives and desired outcomes for gender-focused efforts. OGAC should issue guidance for how to operationalize, implement, monitor, and evaluate activities and interventions to achieve these objectives. (Chapter 8)

Despite remarkable scale-up in PEPFAR partner countries, an all-encompassing challenge is the substantial remaining unmet need for all services and programs that are part of an effective response to HIV. For example, for antiretroviral therapy, fundamental challenges are posed by the large numbers of currently enrolled patients who need to be maintained, the patients who are currently eligible but not yet enrolled, and the potential for expansion of eligibility under new World Health Organization guidelines. For infants, children, and adolescents, service coverage in the continuum of testing, care, and treatment remains proportionally much lower than the coverage for adults. Programs for orphans and vulnerable children and adolescents also struggle to cover service needs in this population. Across HIV programs, an important goal for the future is for PEPFAR to work with partner countries and global partners, in the face of limited resources, to sustain the gains made and to continue to make progress in controlling the HIV epidemic.

Strengthening Health Systems for the HIV Response in Partner Countries

PEPFAR has made considerable contributions in many areas of health system functioning in partner countries. Its substantial support for laboratory strengthening has had fundamentally positive effects for the response to HIV and has been leveraged to improve the functioning of entire health systems. PEPFAR has also improved the functional components of systems that supply essential medications and other commodities critical for providing all health services. Despite this improvement, in many countries challenges remain with the consistency and reliability of supply chain functioning, which in turn affects sustainability and cost-effectiveness. PEPFAR has expanded the health workforce with the capacity to provide HIV services in partner countries; these contributions are now transitioning appropriately to more pre-service education and training, including initiatives for strengthening academic institutions, degree programs, and long-course trainings in countries. PEPFAR has also supported individual and organizational capacity building for leadership and for program and financial management across the governmental, private, and civil society sectors.

PEPFAR has supported the development and strengthening of national health information systems, with investments primarily in training and analytics, supply chain management, human resource information systems, laboratory management systems, patient record management systems, and electronic health records. When PEPFAR began, its focus on collecting data to monitor and report on the implementation of its programs led, when this capability was not available in partner countries, to PEPFAR-specific systems; these systems are now being increasingly aligned with national data collection for health as well as with global HIV indicators. Tensions remain between PEPFAR's data requirements for its own accountability and its aims to align with data collection for national systems, but PEPFAR is seeking to resolve this issue through enhanced support to strengthen national health information systems.

In service delivery, PEPFAR's impressive achievements represent the success of a largely disease-specific approach. In some countries, an early emphasis on increasing service volume to meet service delivery targets did not always facilitate service integration. Many stakeholders in partner countries have identified a need for greater integration of HIV services into the general health system. This is now an articulated goal for PEPFAR, but best practices for effective and efficient service integration are needed to facilitate scale-up. Another important need is ensuring the ongoing quality of services provided and programs implemented, especially through future transitions in implementation models for PEPFAR-supported programs.

PEPFAR's reauthorization created strategic opportunities for more formal support of health systems strengthening as a key contributor to sustainability in partner countries, encompassing all six building blocks in the World Health Organization framework: medical products and technologies, workforce, leadership and governance, financing, information systems, and service delivery.

To support the delivery of HIV-related services, make progress toward sustainable management of the HIV response, and contribute to other health needs, PEPFAR should continue to implement and leverage efforts that have had positive effects within partner country health systems. PEPFAR should maintain efforts in all six building blocks but have a concerted focus on areas that will be most critical for sustaining the HIV response, especially workforce, supply chain, and financing. (Chapter 9)

Enhancing service delivery through existing local systems and long-term infrastructure development will continue to strengthen and expand the capacity of health and other systems to provide the services that are fundamental to an effective response to HIV, one that can meet the current and future trajectory of need. There is a need for future U.S. government investments to support long-term capacity building that fosters the placement and retention of trained personnel in partner countries to accelerate progress toward country ownership and sustainability.

To contribute to a country-owned and sustainable HIV response, the Office of the U.S. Global AIDS Coordinator should develop a comprehensive plan for long-term capacity building in partner countries. The plan should target four key areas: service delivery, financial management, program management, and knowledge management. (Chapter 10)

Transitioning to a Sustainable Response in Partner Countries

PEPFAR has increasingly supported partner countries in the development of national frameworks, policies, and strategic plans. Participating in an intergovernmental planning process with partner country governments—one that includes multisectoral government participation as well as other local stakeholders and external donors—is one of the primary tools that PEPFAR uses to enhance leadership and governance and to support country ownership through mutual transparency, responsibility, and accountability. The U.S. government, like all donors, has its own considerations and requirements for funding decisions, but PEPFAR has made progress in making its considerations a part of joint planning processes rather than a displacement of country priorities. This joint planning includes both local processes for national plans as well as PEPFAR-specific processes, especially Partnership Frameworks. By necessity, PEPFAR will gradually cede control as partner countries adopt more dominant roles in setting strategic priorities for investments in their HIV response and in accounting for their results.

OGAC has recently articulated PEPFAR's understanding of country ownership and provided clarity about ways to mutually assess progress toward sustainability of a more country-led response. This transition to sustainability will be affected by many criteria and decisions, most of which will vary by country. Transitioning will take time; it cannot be achieved on a prescribed generic timeline across PEPFAR. Along the way, major dilemmas, such as differences in how to prioritize services and target populations, will require mutual resolution. In addition, transitioning to new models of PEPFAR support, including less direct support for service delivery and more technical assistance and systems strengthening, is part of a reasonable strategy for achieving sustainable management, but it also carries the inherent risks that in the transition period the same level of targets and access to services will not be achievable and that the quality of services, programs, and data may diminish. At the same time, greater embedding of HIV services in national health systems may offer opportunities for better integration of care, greater efficiencies, and broader health benefits.

There is strong leadership in partner countries for the HIV response, but many of these countries rely heavily—and in some cases almost exclusively—on U.S. bilateral assistance or the Global Fund. This reliance creates fragility and the possibility that the response would be disrupted if funding were discontinued or severely reduced. It is not realistic to expect that partner countries would be able to independently finance the entirety of HIV programming as it is currently implemented, and the critical importance of a global commitment to the HIV response remains. Yet, this does not abate the importance of partner country governments finding ways to reduce the fragility and dependence of their response by increasing their funding contributions, diversifying the sources of external funding that they receive, and making strategic, albeit difficult, decisions about the efficient use of available resources.

Building on the Partnership Framework implementation process, PEPFAR should continue to work with partner country governments and other stakeholders to plan for sustainable management of the response to HIV. PEPFAR should support and participate in comprehensive country-specific planning that includes the following:

• Ascertain the trajectory of the epidemic and the need for prevention, care and treatment, and other services.
• Identify gaps, unmet needs, and fragilities in the current response.
• Estimate costs of the current response and project resource needs for different future response scenarios.
• Develop plans for resource mobilization to increase and diversify funding, including internal country-level funding sources.
• Encourage and participate in country-led, transparent stakeholder coordination and sharing of information related to funding, activities, and data collection and use.
• Establish and clearly articulate priorities, goals, and benchmarks for progress. (Chapter 10)

PEPFAR is not alone in trying to achieve locally led, sustainable health and development objectives. Contributing stakeholders, including partner countries, will need to set priorities and allocate resources, based on mutually agreed-upon principles, to achieve a strategic and ethical balance between maintaining current coverage and expanding to address unmet needs. Ongoing support in partner countries to strengthen capacity for decision making informed by evidence will be needed to ensure that gains are not lost in achieving sustainable management of HIV programs, equitable access to services for those who are most in need, and sustainable control of the HIV epidemic.

Transforming Knowledge Management to Improve Effectiveness

PEPFAR's ability to generate, use, and disseminate knowledge is fundamental for program management and improvement and, ultimately, for the sustainability of PEPFAR's efforts. PEPFAR has made strong efforts in this area, often at levels not seen in other development initiatives, by creating a program monitoring data collection system to track activities and program results; supporting epidemiologic and surveillance activities; strengthening partner country health information systems; implementing various program evaluation approaches; and supporting some research across a wide range of technical areas. PEPFAR has generally utilized the resulting knowledge to drive program activities, implement evidence-informed interventions, and make modifications as new knowledge and scientific evidence have emerged. Yet, there are key areas where the information needed to assess efforts and guide future activities is not sufficient or is not available in a manner that facilitates use.

PEPFAR's indicators, like many program monitoring systems, are focused primarily on outputs, such as the number of individuals provided with a service. These serve an important function to monitor implementation of activities but do not reflect quality, efficiency, or effectiveness. Measuring program progress and effectiveness is not always best achieved through program monitoring systems. Therefore, strategic and coordinated evaluation and research are also critical activities that complement program monitoring indicators in order to assess meaningful outcomes and to continually improve the effectiveness and impact of PEPFAR investments. In addition, support for epidemiological data collection through surveillance and special studies in partner countries, which has been a cornerstone of PEPFAR's contribution, continues to be fundamental to supporting joint planning with partner countries.

PEPFAR would benefit from a more purposeful and strategic determination of which internal and external stakeholders need to know what information, at what level of the PEPFAR operational infrastructure, covering what scope of PEPFAR's efforts, and with what frequency. The limited personnel, time, and financial resources for knowledge management could then be allocated to monitoring, evaluation, research, and dissemination activities that meet these needs, while reducing the burden of collecting and reporting data and other information that is not useful.

PEPFAR will need to transform its approach to knowledge management in order to adapt to a transition from direct support for delivery of services and programs to increased support and technical assistance for systems strengthening, capacity building, and sustainable management of the response by partner country stakeholders. An investment now to develop reliable, credible approaches to assess the effectiveness of these efforts will be needed to document future progress and to continually improve future efforts. The ability to attribute results by counting services provided or beneficiaries reached will become less relevant; in fact, direct attribution will no longer be an appropriate expectation for accountability. PEPFAR could seize this opportunity to work with others in the global health and development assistance communities to develop appropriate ways to assess contributions to the improved performance and effectiveness of national efforts.

The Office of the U.S. Global AIDS Coordinator (OGAC) should develop a comprehensive knowledge management framework, including a program monitoring and evaluation strategy, a prioritized and targeted research portfolio, and systems for knowledge dissemination. This framework should adapt to emerging needs to assess PEPFAR's models of implementation and contribution to sustainable management of the HIV response in partner countries. (Chapter 11)

This knowledge management framework will require that PEPFAR implement and strategically allocate resources for the following:

A.

To better document PEPFAR's progress and effectiveness, OGAC should refine its program monitoring and evaluation strategy to streamline reporting and to strategically coordinate a complementary portfolio of evaluation activities to assess outcomes and effects that are not captured well by program monitoring indicators. Efforts should support innovation in methodologies and measures where needed. Both monitoring and evaluation should be specifically matched to clearly articulated data sources, methods, and uses at each level of PEPFAR's implementation and oversight.

OGAC's program monitoring reporting structure can be streamlined by focusing on program improvement at the partner level, monitoring at the country level, and strategic oversight of accountability for contribution at the headquarters level. To reduce duplicative efforts and investments in its evaluation portfolio, OGAC should coordinate among country programs to strategically plan and coordinate a subset of evaluations designed not only to be useful at the country level but also to enable comparability across programs and countries in order to assess performance and inform improvements across PEPFAR.

B.

To contribute to filling critical knowledge gaps that impede effective and sustainable HIV programs, OGAC should continue to redefine permitted research within PEPFAR by developing a prioritized portfolio with articulated activities and methods. The planning and implementation process at the country and program level should inform and be informed by the research portfolio, which should focus on research that will improve the effectiveness, quality, and efficiency of PEPFAR-supported activities and will also contribute to the global knowledge base on implementation of HIV/AIDS programs.

PEPFAR's scope, scale, and experience mean that it is uniquely situated as a platform for research to spur innovation and to address knowledge gaps that can undermine the effective planning, implementation, and measurement of the effectiveness of programs at scale. Research and evaluation activities that emphasize in-country local participation and expertise can also enhance local capacity and contribute to country ownership.

C.

To maximize the use of knowledge created within PEPFAR, OGAC should develop systems and processes for routine, active transfer and dissemination of knowledge both within and external to PEPFAR. As one component, OGAC should institute a data-sharing policy, developed through a consultative process. The policy should identify the data to be included and ensure that these stipulated data and results generated by PEPFAR or through PEPFAR-supported activities are made available in a timely manner to PEPFAR stakeholders, external evaluators, the research community, and other interested parties.

PEPFAR would benefit from building on its most successful current mechanisms for sharing data, information, and knowledge to develop more systematic documentation and dissemination; there is a particular need to more effectively facilitate the direct transfer of experiences, best practices, and lessons learned across countries, implementing partners, and sites.