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Committee on Planning the Assessment/Evaluation of Programs Implemented
Under the U.S. Global Leadership Against HIV/AIDS, Tuberculosis,
and Malaria Reauthorization Act of 2008
Board on Global Health
Board on Children, Youth, and Families
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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. SAQMMA09M0693 (STAT-3977) between the National
Academy of Sciences and 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.
International Standard Book Number-13: 978-0-309-15393-5
International Standard Book Number-10: 0-309-15393-X
Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W.,
Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington
metropolitan area); Internet, http://www.nap.edu.
For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.
Copyright 2010 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.
Suggested citation: IOM and NRC (Institute of Medicine and National Research Council). 2010. Strategic
approach to the evaluation of programs implemented under the Tom Lantos and Henry J. Hyde U.S.
Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008.
Washington, DC: The National Academies Press.
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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. Charles M. Vest 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. Charles M. Vest are chair and vice chair, respectively, of the
National Research Council.
www.national-academies.org
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COMMITTEE ON PLANNING THE ASSESSMENT/EVALUATION OF PROGRAMS
IMPLEMENTED UNDER THE U.S. GLOBAL LEADERSHIP AGAINST HIV/AIDS,
TUBERCULOSIS, AND MALARIA REAUTHORIZATION ACT OF 2008
ROBERT BLACK (Chair), Bloomberg School of Public Health, Johns Hopkins University
MARTHA AINSWORTH, Independent Evaluation Group, World Bank
PIERRE M. BARKER, University of North Carolina at Chapel Hill and Institute for Healthcare
Improvement
MARY T. BASSETT, Doris Duke Charitable Foundation
RONALD BROOKMEYER, School of Public Health, University of California, Los Angeles
DAVID D. CELENTANO, Bloomberg School of Public Health, Johns Hopkins University
ANGELA DÍAZ, Mount Sinai School of Medicine
LORETTA S. JEMMOTT, University of Pennsylvania School of Nursing
JENNIFER KATES, Henry J. Kaiser Family Foundation
ANN KURTH, New York University College of Nursing
DORA MBANYA, University of Yaoundé I and Centre Hospitalier et Universitaire, Cameroun
AFFETTE McCAW-BINNS, University of the West Indies, Mona Campus, Jamaica
GEETA RAO GUPTA, Bill & Melinda Gates Foundation
DOUGLAS D. RICHMAN, VA San Diego Healthcare System and University of California, San Diego
DEBORAH L. RUGG, The Joint United Nations Programme on HIV/AIDS (UNAIDS)
DAWN K. SMITH, U.S. Centers for Disease Control and Prevention
SALLY K. STANSFIELD, Health Metrics Network, World Health Organization
JANE WALDFOGEL, School of Social Work, Columbia University
KATHRYN WHETTEN, Sanford School of Public Policy, Duke University
CATHERINE M. WILFERT, Retired, Elizabeth Glaser Pediatric AIDS Foundation
Study Staff
KIMBERLY A. SCOTT, Study Director
BRIDGET B. KELLY, Deputy Study Director
IJEOMA EMENANJO, Senior Program Associate
MILA C. GONZÁLEZ, Research Associate
KATE MECK, Research Assistant
KRISTEN DANFORTH, Senior Program Assistant
CARMEN C. MUNDACA, Intern
WENDY E. KEENAN, Program Associate
JULIE WILTSHIRE, Financial Associate
ROSEMARY CHALK, Director, Board on Children, Youth, and Families
PATRICK KELLEY, Director, Boards on Global Health and African Science Academy Development
v
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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 National Research Council’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:
Stefano Bertozzi, Bill & Melinda Gates Foundation
Greg Bisson, University of Pennsylvania School of Medicine
Thomas Coates, University of California Los Angeles, School of Medicine
Lola Dare, CHESTRAD International
Victor DeGruttola, Harvard School of Public Health
Theresa Díaz Vargas, United Nations Children’s Fund
Johanna Dwyer, Tufts University School of Medicine and Friedman School of Nutrition Science &
Policy
Robert Hecht, Results for Development Institute
Phyllis Kanki, Harvard School of Public Health
Kathy Marconi, University of Maryland University College
Peter Mugyenyi, Joint Clinical Research Center, Kampala, Uganda
Robert R. Redfield, University of Maryland School of Medicine
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 Bernard Guyer, Johns Hopkins
University Bloomberg School of Public Health and Edward Perrin, Emeritus, University of Washington.
Appointed by the National Research Council and Institute of Medicine, they were 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.
vii
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Acknowledgments
The committee would like to acknowledge the diverse and important contributions of the
many individuals whose assistance is reflected in this report. First, the Committee would like to
thank the Office of the U.S. Global AIDS Coordinator and the congressional staff who provided
information, guidance, and support. The committee also greatly benefited from the time and
expertise of those who met with committee delegations and participated in public information-
gathering sessions. These individuals are listed in full in Appendix C.
There are a number of individuals who were critical for the administrative and logistical
success of this project. For help with scheduling and communication, the committee would like
to thank Mary Rybczynski, Rachel White, Lola Adedokun, Nancy Leonard, Polina Royzman-
Tabak, Fortuna Salinas, Tanya Davis-Powell, Cindy Ogasawara, Elvira Bustamante, Audrey
Palix, Aubrey Celeste C. Musngi-Anouar, Cindy Chu, and Sharon Abbruscato. The committee is
also grateful to Anthony Mavrogiannis and the staff at Kentlands travel for their assistance with
the travel needs of this project. The committee would also like to thank Kristin Shaw and Megan
Perez for their excellent work on this project as interns at the Institute of Medicine. Carmen
Mundaca also deserves special mention for her valuable research and analytic contributions
during the time she devoted to the project as an intern within her doctoral training program.
ix
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Preface
By the first decade of the 21st century, the world had been grappling with the HIV/AIDS
pandemic for nearly three decades. The countries hardest hit in terms of morbidity and mortality
remain in sub-Saharan Africa, home to an estimated two-thirds of people living with HIV
infection. Although international aid has increased substantially since the beginning of the
pandemic and national government expenditure for HIV prevention, treatment, care, and capacity
building activities also increased in the most affected countries, there remains a funding gap
relative to the estimated need.
In 2003, Congress mandated a study to be conducted by the Institute of Medicine (IOM)
to assess the progress of the implementation of the programs and aid offered in a major new U.S
initiative that became known as the President’s Emergency Plan for AIDS Relief (PEPFAR). The
findings and recommendations of that study informed the processes, policies, and activities of
the program and the reauthorization legislation, 1 known in short as the Lantos–Hyde Act of
2008. This reauthorized legislation mandated another study by the IOM to assess the
performance of United States-assisted global HIV/AIDS programs and evaluate the impact on
health of prevention, treatment, and care efforts that are supported by United States funding (for
a complete description of the elements to be considered in the assessment and evaluation, see the
Statement of Task in Appendix A). In addition to informing Congress and the Department of
State, this newly-mandated, evidence-based IOM study will provide the scientific community,
program implementers, policy makers, civil society, people living with and affected by
HIV/AIDS, and international stakeholders in global public health with a rigorous, non-partisan,
multidisciplinary, and independent evaluation of the PEPFAR program.
This report outlines the design plan for the evaluation of this evolving program that has
geographically expanded to more than twice the number of countries funded at the time of the
first evaluation. This new evaluation is complicated by not only its scale, but also the diversity
created by the characteristics and complexities of each country in which the program operates.
The dynamism as a program in operation parallel to the evaluation itself—and the challenges that
presents—also add complexity. The context in which PEPFAR operates has also shifted, with a
more recent emphasis on transitioning from an emergency response to a longer-term model of
sustainability, promoting country ownership, and strengthening health systems. PEPFAR also
has a new place within the context of international funding as part of the new U.S. Global Health
Initiative (GHI). Less than a year after PEPFAR was reauthorized, the Obama Administration
launched the GHI—a new 6-year (2009–2014), $63 billion government-wide effort to develop a
comprehensive U.S. global health strategy (these funds include PEPFAR funds). The GHI
includes and builds on the success of PEPFAR, but also includes other global health challenges
in a more coordinated approach. As such, the GHI is expected to affect the way in which all U.S.
global health programs operate, including PEPFAR.
This plan includes an illustration of the types of questions that could be addressed in the
evaluation, partitioning and elaborating the areas of interest described in the statement of task.
1
Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria
Reauthorization Act of 2008, Public Law 110-293, 110th Cong., 2nd sess. (July 30, 2008).
xi
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xii PREFACE
The ability to answer these evaluation questions will depend on the availability of timely and
quality data from the Department of State’s Office of the Global AIDS Coordinator and other
sources such as other federal agencies, U.S. Country Teams and implementing partners, other
donors, and other international stakeholders including the Global Fund to Fight AIDS,
Tuberculosis, and Malaria, the World Health Organization, the Joint United Nations Programme
on HIV/AIDS, and the United Nations Children’s Fund. While the evaluation questions
illustrated in this plan will undergo further refinement and prioritization, they are presented here
to facilitate an understanding of not only the type of data needed from the numerous sources, but
also the processes and temporal complexities inherent in responding to the committee’s charge.
The evaluation will be conducted between 2010 and 2012, with a report of the
committee’s findings and recommendations issued in 2012. It will provide insights into the
contributions of the investment made by the United States through PEPFAR to improve and save
lives of men, women, adolescents, and children living with and affected by HIV/AIDS in
developing countries.
In the current time of global economic recessions, limited resources, and stated intentions
to transition to a more sustainable and country-owned response to the pandemic, an even more
urgent priority must be accorded to the identification, dissemination, and scale-up of the most
effective strategies for preventing new HIV infections and meeting the myriad needs of people
already living with HIV/AIDS. The committee hopes to contribute to this knowledge and
understanding.
The committee extends its gratitude to all those who provided information to assist in the
planning committee’s work. In our initial data gathering, we have been able to forge positive
relationships with major global stakeholders. Perhaps the most important milestone in this
planning phase is the commitment of those major global stakeholders to share their data,
analyses, and other invaluable information with the IOM, thereby modeling indispensable
international collaboration to collectively address and understand critical issues and outcomes
related to the pandemic.
In closing, I would like to express my appreciation to the study staff for their superb work
on this project and to the members of the committee for the time and energy they gave so
generously to this project, for the expertise they contributed, and for their participation in robust
discourse and deliberation.
Robert E. Black, Chair
Committee on Planning the Assessment/Evaluation
of HIV/AIDS Programs Implemented Under the
U.S. Global Leadership Against HIV/AIDS,
Tuberculosis, and Malaria Reauthorization Act of
2008
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Contents
SUMMARY OF KEY MESSAGES.......................................................................................................1
PART I: INTRODUCTION AND BACKGROUND
Introduction...............................................................................................................................................7
Background...............................................................................................................................................8
PART II: PROPOSED EVALUATION APPROACH
Congressional Charge and Planning Phase Approach..........................................................................19
Evaluation Goals and Conceptual Framework for Evaluation Design................................................20
Overarching Evaluation Challenges and Limitations...........................................................................27
Evaluation Methodologies .....................................................................................................................28
Data Sources and Analysis.....................................................................................................................38
Workplan ................................................................................................................................................46
PART III: ILLUSTRATIVE EVALUATION DETAILS FOR ASSESSMENT OF
PEPFAR’S PERFORMANCE AND IMPACT
Section 1: PEPFAR’s Knowledge Management ..................................................................................53
Section 2: Mapping PEPFAR Funding .................................................................................................61
Section 3: Prevention Services ..............................................................................................................69
Section 4: Adult and Pediatric Treatment .............................................................................................79
Section 5: Care and Support Services ...................................................................................................89
Section 6: Child and Adolescent Well-Being .......................................................................................99
Section 7: Gender-Related Vulnerability and Risk.............................................................................115
Section 8: Key Systems-Level Goals and Activities ..........................................................................121
REFERENCES.....................................................................................................................................133
APPENDIXES
A Statement of Task.............................................................................................................................143
B Committee and Staff Biographies....................................................................................................145
C Public Committee Meeting Agendas...............................................................................................159
D Glossary ...........................................................................................................................................163
E Sample PEPFAR Country Timelines...............................................................................................175
F Evaluation Committee Workplan.....................................................................................................185
G Sample Data Sources Matrix ...........................................................................................................189
H Illustrative Questions for the Evaluation of PEPFAR’s Health Systems
Strengthening Activities ..........................................................................................................193
xiii
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Tables, Figures, and Boxes
TABLES
1 Current HIV/AIDS Funding from Select Donors Received by PEPFAR Countries (as of April
2010), 64
2 Categories of PEPFAR Prevention Interventions, 71
3 Cumulative Number of People on Antiretroviral Treatment by PEPFAR Country, 79
4 PEPFAR Age Categories for Programs for Orphans and Vulnerable Children, 105
FIGURES
1 Organizational structure of OGAC (last updated October 16, 2007), 11
2 Model structure of PEPFAR Country Teams, 13
3 Program impact pathway for evaluation of PEPFAR’s effects on HIV-related health impact
for children and adults, 24
4 Context for PEPFAR program implementation, 26
5 PEPFAR headquarters-level strategic information partners and headquarters-level data-
gathering sources, 54
6 A public health questions approach to HIV monitoring and evaluation, 56
7 PEPFAR funding landscape, 62
8 PEPFAR FY2008 obligations to prime partners: U.S., local, or other location stratified by
key sector, 67
9 Program impact pathway for evaluation of PEPFAR’s prevention programs, 73
10 Program impact pathway for evaluation of PEPFAR’s adult treatment programs, 85
11 Program impact pathway for evaluation of PEPFAR’s pediatric treatment programs, 86
12 PEPFAR care and support services, 90
13 Program impact pathway for evaluation of PEPFAR’s care and support programs, 95
14 Program impact pathway for evaluation of PEPFAR’s services for children and
adolescents, 109
15 Program impact pathway for evaluation of PEPFAR’s gender efforts, 117
16 Representation of WHO’s six building blocks for effective health systems, 126
17 Program impact pathway for evaluation of PEPFAR’s health systems strengthening activities
at the country level, 128
BOXES
1 PEPFAR and the U.S. Global Health Initiative, 16
2a Central U.S. Government Data Sources, 40
2b Multilateral Donor and Other International Data Sources, 42
2c Country Data Sources, 44
2d Other Data Sources (Single or Multi-Country), 45
3 Areas of Emphasis in PEPFAR II’s New Five-Year Strategy for Treatment, 84
4 Reauthorization Programming for Orphans and Vulnerable Children, 102
xv
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Acronyms and Abbreviations
AEI African Education Initiative
AIDS acquired immune deficiency syndrome
APR annual program results
ART antiretroviral therapy
ARV antiretroviral
BCC behavior change communication
CD4 cluster of differentiation 4
CDC U.S. Centers for Disease Control and Prevention
COP country operational plan
COPRS Country Operational Plan Reporting System
CRC Committee on the Rights of the Child
CSW commercial sex worker
CTX cotrimoxazole
DHS Demographic and Health Surveys
DoS U.S. Department of State
EID early infant diagnosis of HIV
FY fiscal year
GHI The U.S. Global Health Initiative
Global Fund The Global Fund to Fight AIDS, Tuberculosis, and Malaria
HAPSAT HIV/AIDS Program Sustainability Analysis Tool
HIV human immunodeficiency virus
IDU injecting drug user
IOM U.S. Institute of Medicine
IPTp intermittent preventive treatment of malaria for pregnant women
ITNs insecticide-treated nets
M&E monitoring and evaluation
MDG Millennium Development Goal
MICS Multiple Indicator Cluster Survey
MSM men who have sex with men
NGO non-governmental organization
OECD Organisation for Economic Co-operation and Development
OGAC Office of the U.S. Global AIDS Coordinator
OI opportunistic infection
OMB Office of Management and Budget
PCR polymerase chain reaction
PEP post-exposure prophylaxis
PEPFAR The President’s Emergency Plan for AIDS Relief
PEPFAR I The President’s Emergency Plan for AIDS Relief (2004–2008)
PEPFAR II The President’s Emergency Plan for AIDS Relief (2009–2013)
PHE public health evaluation
PLWHA people living with HIV/AIDS
PMI The President’s Malaria Initiative
xvii
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xviii ACRONYMS AND ABBREVIATIONS
PMTCT prevention of mother-to-child transmission
PrEP pre-exposure prophylaxis
SI strategic information
SPRs semi-annual progress results
TAB Technical Advisory Board
TB tuberculosis
TWG Technical Working Group
UNAIDS United Nations Joint Programme on HIV/AIDS
UNGASS United Nations General Assembly Special Session
UNICEF United Nations Children’s Fund
USAID United States Agency for International Development
USG United States Government
WHO World Health Organization