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Summary of Key Messages Since 2003, the United States has supported programs to combat global HIV/AIDS through an initiative that is known as the President’s Emergency Plan for AIDS Relief (PEPFAR). The Lantos–Hyde Reauthorization Act of 2008 mandated a study by the Institute of Medicine (IOM) to assess and evaluate the performance and progress of the PEPFAR program and the impact on health of the program’s activities, and to make recommendations to improve the U.S. government response to global HIV/AIDS. As the first phase of this study, the IOM was charged to form an ad hoc committee to develop a plan for the evaluation and to issue a short report to the U.S. Congress on the plan’s proposed design, taking into consideration the requirements for the congressionally mandated study (stated in Appendix A). This report presents an overview of the strategic approach and conceptual framework for the assessment and evaluation of PEPFAR. A transition period for operational planning will take place during congressional review of the strategic approach described in this report. In this operational planning phase, IOM staff, planning committee members, and consultants will carry out activities to further develop and refine the plan and to inform and prepare for the implementation of the evaluation. The evaluation itself will be conducted beginning in the fall of 2010, with a report of the findings and recommendations to be issued in 2012. The IOM will convene a new ad-hoc committee, with significant overlap from the membership of the planning committee, to conduct the evaluation as a consensus study. The following key messages summarize the major elements of the evaluation approach. A program impact pathway reflects the rationale for how PEPFAR inputs and activities, including services, capacity building, technical assistance, and policy development, can be plausibly linked to effects on HIV-specific health impacts. The program impact pathway contains five major elements: investments or inputs to the program; activities that provide services and support to those in need; outputs from these activities; outcomes that are measurable intermediate effects; and the ultimate goal of health impact. This approach supports an assessment of whether the program is performing in the way it is intended along the full range of its implementation, rather than simply an evaluation of its ultimate impact. This will allow for refined conclusions about elements of the program that are functioning well or that could be improved to result in a greater impact on health. Within countries that receive PEPFAR support, a wide range of factors affect the implementation of the program and health outcomes, including cultural, societal, geographical, and political factors and influences, as well as the presence of investments and activities from a range of other external and country-level sources that are aimed at achieving the same health impact. Given the multiplicity of other factors that influence outcomes, the goal of the analysis will be to assess PEPFAR’s contribution to changes in health impact, as direct attribution will not be possible. 1

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2 STRATEGIC APPROACH TO THE EVALUATION OF U.S. GLOBAL HIV/AIDS PROGRAMS The evaluation will use a mixed methods approach to answer evaluation questions derived from the study charge and the guiding framework of the program impact pathway. By drawing on a combination of analytical techniques and on a range of both quantitative and qualitative data sources, the convergence among different findings will be assessed to support plausible conclusions about the effects or contributions of PEPFAR programs. The extent to which the evaluation goals can be met will depend on the timely availability of relevant data of sufficient quality. Many evaluation questions will require data that go beyond the indicators that are reported centrally to the Office of the U.S. Global AIDS Coordinator (OGAC). Data will have to be gathered from multiple sources, contingent upon the availability and feasibility of access within the timeframe of the evaluation. The evaluation will draw on existing data and analyses as well as new data collection and new secondary analyses of existing data. Data will be sought from OGAC and other U.S. government agencies; PEPFAR implementing partners; other bilateral and multilateral agencies and donors; country-level data from national governments, implementers, and the research community; the scientific health and development literature; and country studies, including document review and qualitative data collected from a select cross-section of PEPFAR countries during country visits conducted as part of the evaluation. The evaluation plan is designed with sufficient flexibility to adapt, to the extent possible, to the ongoing evolution of the PEPFAR program as well as to new policy issues, new information, and new sources of data that emerge as the evaluation itself proceeds. There will be limitations to the assessment due to the nature of the available data, the timing of the evaluation, and the distinct characteristics and complexities of each country in which the program operates. Much of the data is not collected and/or reported systematically across PEPFAR. In most cases, the available data will be country-specific, implementing-partner-specific, or program component-specific. This will limit the ability to generalize or aggregate findings to the whole of the program, especially given the considerable heterogeneity in the implementation of PEPFAR across different countries and programs. However, with careful interpretation, the available data can inform conclusions that contribute to an understanding of the performance and impact of PEPFAR as a whole. Some effects described in the statement of task, such as the impact on child mortality and on 5-year survival rates, will be particularly difficult to evaluate due to the limited available data that directly measure the desired outcome or impact. Instead, other measures and methods will be used to assess program effects on, for example, HIV incidence, outcomes for people living with HIV/AIDS, and child health. It will be difficult to evaluate the impact of recent and imminent programmatic changes in response to the goals for shifting to a sustainable response because there will be insufficient time for these changes to be translated from implementation into measurable effects. However, the evaluation will assess efforts and process in these areas to provide insight into whether PEPFAR is making reasonable progress toward these new goals.

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3 SUMMARY OF KEY MESSAGES Within the parameters of the evaluation design, the conclusions in the final report will focus on assessing the implementation and effects of program components and on providing guidance that aims to maximize the potential for programs to have a future positive health impact. Based on the conclusions of the evaluation, the IOM will make recommendations that focus on improving the U.S. government response to global HIV/AIDS, including support for and alignment with global and local responses at the country level. The recommendations will be intended to inform decisions about how to identify, disseminate, and scale up the most effective and efficient strategies in order to make the best use of limited resources to accomplish PEPFAR’s evolving goals for a transition to a sustainable, country-owned response to the pandemic. The evaluation described in this plan can be expected to contribute to the understanding of large-scale programmatic strategies to meet the needs of those living with HIV and AIDS and to prevent new HIV infections. The study will provide a rigorous, non-partisan, multidisciplinary, and independent evaluation of the PEPFAR program that will inform Congress and the Department of State, as well as the scientific community, program implementers, policy makers, civil society, people affected by HIV/AIDS, and international stakeholders in global public health.

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