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Plan for a Short-term Evaluation of PEPFAR Implementation

Letter Report # 1

Committee on the President’s Emergency Plan for AIDS Relief (PEPFAR) Implementation Evaluation

Board on Global Health

Board on Children, Youth, and Families

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES
Washington, D.C.
www.nap.edu



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Plan for a Short-term Evaluation of PEPFAR Implementation: Letter Report # 1 Plan for a Short-term Evaluation of PEPFAR Implementation Letter Report # 1 Committee on the President’s Emergency Plan for AIDS Relief (PEPFAR) Implementation Evaluation Board on Global Health Board on Children, Youth, and Families INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES Washington, D.C. www.nap.edu

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Plan for a Short-term Evaluation of PEPFAR Implementation: Letter Report # 1 THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract No. SAQMPD04C1166 between the National Academy of Sciences and U.S. Department of State. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. Additional copies of this report are available in limited quantities from the Committee for the Evaluation of PEPFAR Implementation; Board on Global Health; Institute of Medicine; 500 Fifth Street, N.W., Washington, DC 20001. The full text is available online at http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2006 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Plan for a Short-term Evaluation of PEPFAR Implementation: Letter Report # 1 “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Advising the Nation. Improving Health.

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Plan for a Short-term Evaluation of PEPFAR Implementation: Letter Report # 1 THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm.A.Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J Cicerone, and Dr. Wm.A.Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Plan for a Short-term Evaluation of PEPFAR Implementation: Letter Report # 1 COMMITTEE FOR THE EVALUATION OF PEPFAR IMPLEMENTATION JAIME SEPULVEDA AMOR, (Chair), Director General, National Institutes of Health, Mexico HELEN SMITS, (Vice Chair), Former Faculty of Medicine, Eduardo Mondlane University, Mozambique CHARLES CARPENTER, (Treatment Subcommittee Chair), Professor of Medicine, Bio Med Medicine, Miriam Hospital, Brown University, Providence, Rhode Island JAMES CURRAN, (Prevention Subcommittee Chair), Dean, Professor of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia WILLIAM L.HOLZEMER, (Care Subcommittee Chair), Professor of Nursing and Associate Dean, International Programs, School of Nursing, University of California, San Francisco STEFANO BERTOZZI, Director of Health Economics, National Institutes of Health, Mexico GEOFF GARNETT, Professor of Microparasite Epidemiology, Faculty of Medicine, Imperial College, London, United Kingdom RUTH MACKLIN, Head, Division of Philosophy and History of Medicine, Department of Epidemiology and Population Health, Albert Einstein College of Medicine, New York AFFETTE McCAW-BINNS, Professor, Reproductive Health Epidemiology, Section of Community Health, University of the West Indies, Jamaica A.DAVID PALTIEL, Associate Professor and Head, Division of Health Policy and Administration, Yale University, New Haven, Connecticut PRISCILLA REDDY, Director, Health Promotion Research and Development, National Health Promotion & Behavioural Intervention Research Unit, Medical Research Council of South Africa DAVID ROSS, Director, Public Health Informatics Institute, Decatur, Georgia HEATHER WEISS, Director, Harvard Family Research Project, Harvard University, Boston, Massachusetts Subcommittee Members, Liaisons, and Study Consultants MAUREEN BLACK, John A.Scholl Professor of Pediatrics, University of Maryland School of Medicine, Baltimore HOOSEN COOVADIA, Victor Daitz Professor of HIV/AIDS Research, Centre for the AIDS Programme of Research, South Africa HENRY FOMUNDAM, Acting Director, National HIV and AIDS Programme, MEDUNSA Pharmacovigilance Centre, South Africa PAUL GERTLER, Chief Economist, Human Development Network, World Bank, Washington, D.C. CARL LATKIN, Professor, Department of Health, Behavior, and Society, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland JAMES NTOZI, Professor, Department of Population Studies, Makerere University, Uganda JAMES SHERRY, Vice President, Policy, Research and Advocacy, Global Health Council, Washington, D.C. OLAITAN SOYANNWO, Professor of Anesthesia and Consultant Anesthetist, College of Medicine, University of Ibadan and University College Hospital, Nigeria BURTON WILCKE, Jr., Chair and Associate Professor, Department of Biomedical Technologies, University of Vermont, Burlington MICHAEL MERSON, (Board on Global Health Liaison), Anna M.R.Lauder Professor of Public Health, Yale School of Medicine, New Haven, Connecticut ELENA O.NIGHTINGALE, (Board on Children, Youth, and Families Liaison), Scholar-in-Residence, Institute of Medicine, The National Academies, Washington, D.C. JULIA COFFMAN, (Consultant), Independent Evaluation Consultant, Alexandria, Virginia THOMAS N.DENNY, (Consultant), Associate Professor Pathology, Laboratory Medicine, Associate Professor of Pediatrics, Associate Professor of Preventive Medicine and Community Health and Assistant Dean for Research in Health Policy UMD— New Jersey Medical School, New Jersey FLORENCIA ZULBERTI, (Consultant), Assistant Director for Global Health, National Institutes of Health, Mexico

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Plan for a Short-term Evaluation of PEPFAR Implementation: Letter Report # 1 Staff PATRICK KELLEY, Director, Board on Global Health ROSEMARY CHALK, Director, Board on Children, Youth, and Families MICHELE ORZA, Study Director ALICIA GABLE, Senior Program Officer (until June 2005) KIMBERLY SCOTT, Senior Program Officer (from September 2005) HEATHER COLVIN, Program Officer (until July 2005) J.ALICE NIXON, Program Officer (from July 2005) WEZI MUNTHALI, Research Associate (until October 2005) ALYSON SCHWABER, Research Associate (until September 2005) DIANNE STARE, Research Assistant (until September 2005) ANGELA MENSAH, Senior Program Assistant (from June 2005) KIMBERLY WEINGARTEN, Senior Program Assistant ELIZABETH SHARP, Science and Technology Policy Fellow (January 2005 through April 2005) SHARLENE BAGGA, Science and Technology Policy Fellow (June 2005 through August 2005) CLAUDIA GROSSMAN, Science and Technology Policy Fellow (June 2005 through August 2005)

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Plan for a Short-term Evaluation of PEPFAR Implementation: Letter Report # 1 REVIEWERS This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Solomon R.Benatar, Professor of Medicine and Director, Bioethics Centre, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, Republic of South Africa Thomas J.Coates, Professor, Department of Medicine, Division of Infectious Diseases, Prevention and Policy Research, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California Nils Daulaire, President and CEO, Global Health Council, White River Junction, Vermont Anne Mills, Professor of Health Economics and Policy, London School of Hygiene and Tropical Medicine, London, United Kingdom Philop Onyebujoh, Special Programme for Research and Training in Tropical Diseases, World Health Organization, Geneva, Switzerland Mauro Schechter, Professor of Infectious Diseases, and Head, AIDS Research Laboratory, Hospital Universitario Clementino Fraga Filho Universidade, Rio de Janeiro, Brazil Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Neal A.Vanselow. Appointed by the National Research Council and Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Plan for a Short-term Evaluation of PEPFAR Implementation: Letter Report # 1 PREFACE Concern for the over 40 million people infected with HIV and others at risk of infection or otherwise affected through the impact on their families and communities moved the US Congress on behalf of the American people to pass in May 2003 an unprecedented $ 15 billion international public health initiative—the US Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act. With so much at stake from both a human and a fiscal perspective, Congress mandated that the Institute of Medicine review the groundbreaking initiative created by the legislation—the President’s Emergency Plan for AIDS Relief (PEPFAR). An independent, rigorous, multidisciplinary expert review of PEPFAR is in the best interests of the taxpayer, the scientific community, program implementers, and—most importantly—the people whose lives are in the balance. The IOM’s legislative mandate to conduct an evaluation of PEPFAR is a complex challenge, in part because PEPFAR is effectively many programs in one. PEPFAR seeks to prevent seven million HIV infections, provide two million HIV-infected people with antiretroviral therapy, and care for ten million people affected by HIV/AIDS. These people live in fifteen different “focus countries”, most with limited health care system capacity for scale-up of HIV/AIDS-related services. Thus, our evaluation is of a multiplicity of programs that assume the characteristics and complexities of each of the focus countries. The legislative mandate calls for our study of PEPFAR to be delivered at the three-year mark and in time to inform reauthorization discussions. This report outlines our plan for the mandated study, to be published next fall. Due to delays between passage of the legislation, appropriation of funds, and initiation of programs, we are required to evaluate PEPFAR very early in its implementation when many of its programs are relatively immature. Our short-term evaluation can provide insights into whether PEPFAR is making reasonable progress toward its goals and can suggest ways in which the program can be improved to ensure that it ultimately meets its goals. However, it cannot adequately measure what matters most—the impact on the lives of the people the legislation seeks to serve. In recognition of this, in addition to providing the short-term evaluation that will be responsive to the legislative mandate, the IOM Committee was charged to plan a long-term evaluation to determine whether PEPFAR has ultimately succeeded in improv-

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Plan for a Short-term Evaluation of PEPFAR Implementation: Letter Report # 1 ing the lives of the people in the focus countries by preventing infections, treating patients, and caring for people. We plan to publish the plan for a long-term study shortly after publication of the mandated report. Our collective responsibility in caring for those in need around the world demands that the challenge of the global HIV/AIDS pandemic be met in a way that is ethically, scientifically, and fiscally sound. We have been humbled by the myriad of questions raised by this global pandemic about how to most effectively prevent the spread of this disease and care for those affected by it. Given limited resources, there is an obligation to match the will to help others with the will to learn how best to help them. This international IOM committee has taken on the challenge of evaluating PEPFAR with determination and humility and is passionately committed to contributing to the effectiveness of PEPFAR in confronting the HIV/AIDS pandemic. We appreciate the help received from so many to date in developing this plan and look forward to a collaborative process of learning together as it is implemented. Jaime Sepulveda Amor, MD, Dr. Sc. Chair