HIV Prevention: A Comprehensive Approach

Pizer

Brief Table of Contents

Copyright Page

Dedications

Foreword

About the Editors

Notes on Contributors

Acknowledgments

Introduction

I. Epidemiological and biological issues in HIV prevention

Chapter 1. Current and futuretrends

Chapter 2. Understanding the biology of HIV-1 transmission

Chapter 3. HIV vaccines

Chapter 4. Microbicides

Chapter 5. Using antiretrovirals to prevent HIV transmission

Chapter 6. Male circumcision and HIV prevention

II. Behavioral issues in HIV prevention

Chapter 7. Payoff from AIDS behavioral prevention research

Chapter 8. Individual interventions

Chapter 9. Couples' voluntary counseling and testing

Chapter 10. Updating HIV prevention with gay men

Chapter 11. Reducing sexual risk behavior among men and women with HIV infection

Chapter 12. Injection drug use and HIV

Chapter 13. HIV risk and prevention for non-injection substance users

Chapter 14. Preventing HIV among sex workers

Chapter 15. Interventions with youth in high-prevalence areas

Chapter 16. Interventions with incarcerated persons

Chapter 17. Preventing mother-to-child transmission of HIV

III. Structural and technical issues in HIV prevention

Chapter 18. Harm reduction, human rights and public health

Chapter 19. HIV testing and counseling

Chapter 20. Structural interventions in societal contexts

Chapter 21. Evaluating HIV/AIDS programs in the USand developing countries

Chapter 22. Adapting successful research studies in the public health arena

Table of Contents

Copyright Page

Dedications

Foreword

About the Editors

Notes on Contributors

Acknowledgments

Introduction

I. Epidemiological and biological issues in HIV prevention

Chapter 1. Current and futuretrends

Estimates and projections: methodology and refinements

Sub-pandemics in different world regions

Sub-saharan africa

Asia

Europe, oceania and the americas

Conceptual framework for HIV prevention

Multimodality of risk factors and impact on prevention interventions

Sexual mixing rates

Abstinence, be faithful, condoms (ABC)

Treatment of STIs, and male circumcision

Voluntary counseling and testing: individual, dyad, network and community

Acute infection

Antiretroviral drugs for prevention

Gender-power and poverty dynamics

Future trends

Conclusions

Uncited Reference

Chapter 2. Understanding the biology of HIV-1 transmission

The assault force: HIV in genital secretions

Factors affecting genital HIV levels and infectiousness

Establishing a beachhead: the cellular organization of genital tract and rectal tissues, and early events in HIV sexual transmission

Studies of HIV sexual transmission mechanisms in animal models

In vitro studies of HIV transmission mechanisms using explant tissue models

Blocking transmission: host immune defense

Summary and future directions

Chapter 3. HIV vaccines

Transmission and immunology of HIV and associated vaccine challenges

Immunology and host defenses

Traditional vaccine constructs

Transmission physiology and primary infection

Challenges for HIV vaccine development

Approaches to developing an HIV vaccine

Measure of success and surrogate markers

Advanced clinical trial design

Vaccine approaches and evaluations

Vaccines to elicit neutralizing antibodies

Vaccines to elicit cellular response

Vaccine candidates

Live-attenuated/killed viruses

Peptide and subunit vaccines

Viral vectors (Ad5, MVA, novel)

DNA vaccines

Heterologous prime-boost

Delivery methods (mechanical) and adjuvants

Consideration for insert selection

Vaccine trials

Past trials

Ongoing and upcoming efficacy trials

Early-phase trials

Organizations, costs, and funding

Ethical considerations

Multiclade issues

Oversight and review

Confidentiality and social harms and benefits

Community involvement

Counseling in high-risk populations

Care of infected volunteers

The future of HIV vaccine efforts

Conclusions

Acknowledgment

Uncited References

Chapter 4. Microbicides

The biological rationale for microbicides

Microbicide development

The microbicide pipeline

Challenges to microbicide development

Retention

Adherence

Pregnancy

Viral resistance

Socio-cultural perspectives on trial conduct in the developing world

Microbicides as part of the broader prevention agenda

Providing access to microbicides

Microbicide development remains a critical component of HIV prevention research

Chapter 5. Using antiretrovirals to prevent HIV transmission

HIV transmission

HIV in genital secretions

Acute HIV infection

ART pharmacology

ART in the genital tract

Phosphorylation of N(t)RTIs

ART to Prevent Transmission of HIV

Effects of ART on Infectiousness

Prevention of mother-to-child transmission

ART for post-exposure prophylaxis (PEP)

Post-exposure ART in animal models

Post-exposure prophylaxis following occupational exposure

Non-occupational post-exposure prophylaxis

Clinical studies of non-occupational post-exposure prophylaxis

Antiretroviral selection for non-occupational post-exposure prophylaxis

Pre-exposure prophylaxis to prevent HIV transmission

Animal models of pre-exposure prophylaxis

Pre-exposure clinical trials

Topical microbicides as pre-exposure prophylaxis

ART as public health prevention

ART and sexual behaviors: non-occupational post-exposure prophylaxis

Pre-exposure prophylaxis

Antiretroviral therapy for HIV-infected individuals

Antiretroviral therapy for acute HIV infection

ART resistance

Possible future strategies for ART as prevention: acute HIV infection

Intermittent post- or pre-exposure prophylaxis

Newer antiretroviral agents for HIV prevention

Treatment of adolescent and young women

Conclusions

Acknowledgments

Chapter 6. Male circumcision and HIV prevention

Observational data on male circumcision and heterosexual HIV acquisition in men

Male circumcision and HIV acquisition in men who have sex with men

Randomized trials of male circumcision for HIV prevention in men

Biological evidence for the protective effects of circumcision for HIV prevention in men

Circumcision and STI acquisition in men

Male circumcision and HIV/STI infections in women

The safety of male circumcision

The prevalence and acceptability of male circumcision

Male circumcision and behavioral disinhibition or risk compensation

Modeling of the effects of male circumcision on population HIV incidence, the number of surgeries and cost per HIV infection averted

Scale-up of circumcision programs

Uncited references

II. Behavioral issues in HIV prevention

Chapter 7. Payoff from AIDS behavioral prevention research

Periods in AIDS prevention research

Period I (1983–1985): Identification of risk factors (knowledge, attitudes and behaviors (KAB)

Period II (1986–1991): Test of concept of HIV interventions

Payoff from this period

Period III (1992–1997): Multisite, multipopulation randomized controlled trials

Period IV (1998–2004): Technology transfer and cost-effectiveness of programs

Period V (2005–2008): Biomedical prevention and international research

Conclusions

Acknowledgments

Uncited References

Chapter 8. Individual interventions

Stage 1: Common theoretical models applicable to individual interventions for HIV prevention

The biomedical model

The behavioral learning model

The communication perspective

The cognitive perspective

The health belief model

Social cognitive theory

The theory of reasoned action

The theory of planned behavior

The protection motivation model

The information–motivation–behavioral skills model

The self-regulation theory

The transtheoretical model

The relapse prevention model

The health decision model

The AIDS risk reduction model

Stage 2: Selected efficacy trials of HIV prevention interventions based on the conceptual models

Men who have sex with men (MSM)

Injection drug users (IDUs)

Women

Ethnic/racial minorities

Stage 3: Summary and conclusions

Acknowledgment

Uncited References

Chapter 9. Couples' voluntary counseling and testing

Chapter 10. Updating HIV prevention with gay men

What is the evidence base for efficacy of HIV prevention efforts among gay men?

What are the current challenges in HIV prevention work among gay men? What exactly is sexual risk?

What exactly is sexual risk?

Who bears the responsibility for HIV prevention?

Creating self-knowledge as a basis for HIV prevention

Incorporating the demographic diversity of gay men as part of prevention strategies

Addressing the multiple psychosocial health problems that drive risk among gay men

Community viral load approaches to HIV prevention: reducing risk by changing context

How can we translate efficacy into effectiveness?

Towards a prevention cocktail: strategies to move HIV prevention among gay men forward

Steps toward the creation of a prevention cocktail

Chapter 11. Reducing sexual risk behavior among men and women with HIV infection

Sexual behavior among PLWHA

Sex-partner characteristics and transmission risk behaviors

Relationship between HAART and sexual risk behavior

Intervention research addressing reduction in HIV transmission risk among PLWHA

Sexual risk reduction approaches within the HIV primary-care setting

Effectiveness of sexual risk-reduction programs among PLWHA

Integration of HIV prevention programs into the clinical setting

Conclusions

Uncited References

Chapter 12. Injection drug use and HIV

Political and social context of injection drug use

Epidemiology of HIV infection among IDUs

Epidemiologic trends in HIV among IDUs in the United States

Global epidemiologic trends in HIV among IDUs

Factors that have informed prevention andintervention strategies

Demographic characteristics

Drug-use behaviors

Sexual behaviors

Psychosocial factors

Social environmental factors

Successful and unsuccessful interventions

Peer education programs and outreach to IDUs

Social network interventions

Increasing syringe access

Substance-abuse treatment

Anti-drug legislations

Future directions

Uncited References

Chapter 13. HIV risk and prevention for non-injection substance users

Types of interventions used to treat substance use problems

Alcohol

Alcohol use and HIV risk

HIV prevention and alcohol treatment

Non-alcohol substance use

Amphetamine and methamphetamine

Cocaine

Polydrug use

Use of other substances and HIV risk

Popper or nitrite use and HIV risk

Marijuana use and HIV risk

Other substance use and HIV risk

Conclusions

Uncited References

Chapter 14. Preventing HIV among sex workers

Epidemiology, HIV risk and vulnerability among sex workers

Epidemiology of HIV among sex workers

HIV risk among sex workers

Vulnerability of sex workers

Elements of effective interventions

Individual sex-worker-level interventions

Environmental⒳tructural interventions

Monitoring and evaluation of sex-worker interventions

The intervention gap and the need to scale upsex-worker interventions

Model programs from around the world

Avahan, the India AIDS initiative

Project PAPO-HV, Côte d'Ivoire

TAMPEP, Europe

COIN and CEPROSH, Dominican Republic

Challenges for setting up HIV prevention programs for sex workers

Uncited References

Chapter 15. Interventions with youth in high-prevalence areas

Epidemiology of HIV infection in youth

Young women and sexual risk

Factors influencing HIV risk

Delayed sexual debut

Partnership characteristics and patterns of sexual networking

Condom use

Contraception and pregnancy

Alcohol and drug use

Reducing HIV risk

Gender

Structural factors related to HIV risk

Access to resources and services

Socio-cultural norms and values

HIV prevention interventions in youth

Overview of behavioral interventions

National HIV media-based prevention programs

School-based interventions

Linking youth to HIV care and treatment

Out-of-school youth and youth in higher education

Lessons learned from interventions targeted at youth

Conclusion

Chapter 16. Interventions with incarcerated persons

Epidemiology: the epidemic of incarceration in the United States

The disproportionate rate of incarceration of minorities

Substance use and dependence in incarcerated populations

Overlapping risk factors: mental illness, homelessness, sexual abuse

The epidemiology of HIV/AIDS in correctional settings

Hepatitis, STIs and tuberculosis

Intra-prison transmission of HIV

Effects of incarceration on the community

Prevention interventions

The case for routine opt-out testing

Confidentiality

Rapid HIV testing

Treatment and referral as secondary prevention

HIV prevention education for inmates

Condoms in the incarcerated setting

Substance-dependence treatment in correctional facilities

Therapeutic communities (TCs) in prisons and jails

Opiate replacement therapy (ORT) in prisons and jails

Needle exchange in correctional facilities

Needle exchange and tattooing

STD (STI) testing and treatment in the incarcerated setting

HIV/AIDS in international prisons

Future directions

Acknowledgments

Uncited References

Chapter 17. Preventing mother-to-child transmission of HIV

Progress in preventing mother-to-child transmission of HIV

Factors affecting mother-to-child transmission

Principles of prevention of MTCT: a comprehensive approach

The importance of HIV testing in pregnancy

Preventing mother-to-child transmission in high-resource settings: PMTCT advances

Remaining PMTCT challenges in high-resource settings

Preventing MTCT in low-resource settings: advances

Consolidating research into practice guidelines

The possible impact of nevirapine resistance

Infant feeding: mother-to-child transmission through breastfeeding

Risk factors for breast-milk transmission

Interventions to reduce breast-milk transmission

From research to implementation

Uncited References

III. Structural and technical issues in HIV prevention

Chapter 18. Harm reduction, human rights and public health

Review of harm reduction interventions among vulnerable populations

Harm-reduction interventions among IDUs

The HIV epidemic among sex workers

Harm-reduction strategies among sex workers

The HIV epidemic among MSM

Harm-reduction interventions among MSM

The HIV epidemic among incarcerated populations

Harm-reduction strategies among incarcerated populations

Interplay between harm reduction, human rights and public health

Discussion

Chapter 19. HIV testing and counseling

History of HIV testing and counseling

HIV testing and counseling and behavior change

Changing sexual risk behaviors

Cost-effectiveness

HIV testing and counseling models

Voluntary counseling and testing (VCT)

Provider Initiated Testing and Counseling (PITC)

HIV self-testing

Mandatory screening of blood product and organs

Mandatory and compulsory testing of individuals

Expanding HIV testing and counseling to reach specific populations

Prevention of mother-to-child transmission (PMTCT)

Couple- and family-based HIV testing and counseling

Adolescent/youth testing

Other settings and populations

Continuing challenges and emerging issues

Enabling environment

Quality assurance/quality control

Monitoring and evaluation (M&E)

Acute infections and prevention for positives

Advancing HIV testing and counseling

Uncited References

Chapter 20. Structural interventions in societal contexts

Venue-based approaches: wine shops to red-light districts

Social-network based approaches: prevention targeted at negotiating safe sex

Daughters, wives, and mothers: the impact of subordinating women in the home and community

Marriage, monogamy, motherhood and widowhood

Socially-driven HIV interventions that alter the status of women

Breastfeeding and culture

Socially-driven public health responses

Stigma in the medical establishment

Challenges to sex education and communication

Antenatal testing and fertility pressures

Targeting the individual in HIV prevention: condoms and antiretrovirals

Socially relevant HIV prevention

Chapter 21. Evaluating HIV/AIDS programs in the USand developing countries

Issues in defining the evaluation design

Types of evaluations

Use of quantitative and qualitative methods for measuring effectiveness

Internal versus external evaluation

Stakeholders

Objectives and indicators

Types of summative evaluation

Monitoring service utilization (e.g., VCT, PMTCT)

Evaluating interventions at multiple levels

Indicators used to track progress

Examples of interventions at the different levels

Tracking outcomes at the national level (based on individual behavior or biomarkers)

Major challenges in evaluating HIV/AIDS programs

Difficulty of attribution

Dearth of evaluation using cost data

Lack of a single behavioral indicator that links to HIV incidence

Conclusion

Uncited.references

Chapter 22. Adapting successful research studies in the public health arena

Evaluating efficacy, effectiveness, and impact of biological interventions on HIV and STI incidence

Evaluating efficacy, effectiveness, and impact of behavioral interventions on HIV and STI risk behavior

Promoting the successful implementation of science-based HIV prevention: the CDC's approach

Research-to-practice activities in the CDC's Division of HIV/AIDS Prevention

Emerging issues and challenges

Research synthesis

Economic issues

Effectiveness in the community

Adapting interventions

Geography and existing community structures

Community cultures and program content

Promising evidence behavioral interventions

Conclusions

Acknowledgment

Disclaimer

Uncited References

Copyright Page

32 Jamestown Road, London NW1 7BY, UK

30 Corporate Drive, Suite 400, Burlington, MA 01803, USA

525 B Street, Suite 1900, San Diego, California 92101-4495, USA

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopy, recording, or otherwise without the prior written permission of the publisher

Permissions may be sought directly from Elsevier's Science & Technology Rights Department in Oxford, UK: phone: (+44) 1865 843830, fax: (+44) 1865 853333, email: permissions@elsevier.com. Alternatively visit the Science and Technology Books website at www.elsevierdirect.com/rights for further information

Notice

No responsibility is assumed by the publisher for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein. Because of rapid advances in the medical sciences, in particular, independent verifi cation of diagnoses and drug dosages should be made

Library of Congress Cataloging-in-Publication Data

A catalog record for this book is available from the Library of Congress

British Library Cataloguing-in-Publication Data

A catalogue record for this book is available from the British Library

ISBN: 978-0-12-374235-3

For information on all Academic Press publications visit our web site at www.elsevierdirect.com

Printed and bound in the USA

09 10 11 12 13 9 8 7 6 5 4 3 2 1

Dedications

I am grateful to have had parents and relatives who instilled in me an interest in asking questions, constantly learning, working hard, and trying to make the world a better place. The deaths of many dear friends and patients because of AIDS stimulated my early work, and the desire to live in a world without AIDS informs my current efforts.

Kenneth H. Mayer

I dedicate this work to my wife, Christine, who in all ways makes it possible for me to be who I am; and to our marvelous daughter, Katie, and her daughter, Annabel, the newest joy in our lives.

Hank F. Pizer

Foreword

As the AIDS pandemic has evolved in complex ways over the past three decades, so has the field of HIV prevention. The chapters in this very comprehensive book reflect that evolution, and reveal both the many accomplishments we have made and the persistent challenges that confront us in attempting to reduce or eliminate HIV transmission.

Perhaps most notably on the research front, basic biomedical researchers now regularly commune with clinical trials researchers and behavioral interventionists — and, once in a while, even social scientists — in interdisciplinary discussions of HIV prevention topics. Certainly, there are still separate scientific meetings and journals for various disciplines and approaches, but increasingly, there are also mixed conferences and publications, like this book, with a great deal more cross-talk than occurred in the first two decades of the response. As a result, the HIV prevention field as a whole has come to recognize that HIV is fundamentally a pathogen that is transmitted in the course of human relationships that occur and are influenced by social and cultural contexts, and that targeting only one aspect of the interacting biological, behavioral, and social features of HIV/AIDS will have limited effect. As HIV has become a more multi-disciplinary conversation, a number of interrelated issues, challenges, and opportunities have arisen that are addressed directly or indirectly in the chapters of this book.

Conducting multi-disciplinary and multi-level science

Although scientists now talk across disciplines, it remains difficult for their work to be truly interdisciplinary and multi-level. This is a function of increasingly specialized knowledge and training, but also of paradigmatic disagreements about what questions to ask, what methodologies to employ to answer them, what outcome measures to accept as evidence, and how to interpret findings.

Most clinical trials of biomedical technologies for HIV prevention now include behavioral science components, but these more often than not are treated as handmaids to clinical research. They are focused on behavioral issues of relevance to the conduct of the trial — for example, assessing acceptability of or adherence to a product (such as a microbicide candidate, female diaphragm, pre-exposure prophylaxis, etc.) under study, rather than on the more general behavioral and social dynamics affecting the lives of trial participants that might inform the design of the study and its likelihood of success (or failure) in the first place. And, often, when funding is tight, the behavioral components of a trial are the first to be sacrificed as they are still seen by many clinical researchers as dispensable — not necessary for testing the efficacy of a biomedical/technological strategy. But, as behavioral scientists point out, no strategy will be effective — nor trial of it conclusive — if people don't use it, so knowing what motivates or impedes use is essential, not discretionary, and must, therefore, be viewed as an integral part of efficacy trials.

Gaining consensus on appropriate methods and measures for establishing evidence of efficacy

In HIV prevention science, the randomized controlled trial (RCT) with an HIV incidence outcome measure remains the gold standard method for establishing efficacy among the biomedical community. But its hegemony is being challenged by social scientists who argue that experimental methods often are not appropriate for addressing social-level questions. They also note that declining HIV infection rates observed over the course of the pandemic in a number of diverse settings (e.g., San Francisco, Thailand, Uganda, and Senegal) resulted from community-driven behavioral and social change, not from experimental interventions, and that such community-generated responses do offer observational evidence of effectiveness — even if it is not entirely clear to what specific actions the declining infection rates may be attributed. So, while RCTs remain valid and necessary for assessing the efficacy of some types of HIV prevention strategies, they will never produce the entirety of relevant evidence of what actually works in different modes, populations, and settings.

Rather, the HIV prevention field must come to accept a range of ways of knowing in which evidence is derived from different methodologies appropriate to the question and level of analysis being addressed. This includes both quantitative and qualitative data from such methods as RCTs, quasi-experimental interventions, surveys, interviews, ethnography, content analysis, policy analysis, and program evaluation, to name a few.

Moving from efficacy studies to effectiveness studies

There are many small-scale behavioral, biomedical, and social science-based interventions that have shown efficacy in reducing risk and infection through sexual, parental, and perinatal routes in a range of population groups and settings. But we do not yet know how well their outcomes hold up over time, and what their aggregate effect is if fully implemented and scaled-up. Given that adaptation nearly always occurs in intervention replication, it is an open question how loss of fidelity to an original intervention design affects subsequent outcomes. Moreover, implementation of proven interventions at the population level involves confronting a host of individual, institutional, and societal forces that are hard to predict.

The case of male circumcision makes clear the many issues that arise in moving from efficacy to effectiveness. Three clinical trials recently substantiated a wealth of observational data showing adult male circumcision — when conducted under sterile, medical conditions — significantly reduces the risk of HIV transmission from females to males by 50 — 60 percent. Moving from efficacy trials to population-level effectiveness raises a number of issues. First, if circumcision is conducted under non-sterile conditions, there is a risk of harm to men and, potentially, no benefit for reduced HIV transmission. Second, in settings where male circumcision is not common, it will be essential to attend to cultural norms — including religious beliefs and practices surrounding circumcision. The potential for increased risk-taking among circumcised men who may believe they are fully protected from HIV infection is another concern. Any increase in risk-taking, such as decreased condom use and increased number of sex partners, could obviate the benefits of male circumcision and contribute to higher rates of HIV infection in the population. Messaging about partial efficacy and the need to continue engaging in other risk-reduction strategies is quite tricky in the face of new HIV prevention options, like adult male circumcision, that people hope — and believe — will eliminate the need for condom use. (These concerns underscore the need for multi-disciplinary research mentioned above.)

Recognizing the partial efficacy of most HIV prevention strategies, and the contextual issues that affect population-level implementation and uptake of all methods, there now is a call from many quarters to develop a combination approach to HIV prevention — putting together packages of efficacious interventions that are appropriate to particular settings and populations to assess their combined effectiveness.

Impact of an evolving standard of prevention

There is an undisputed ethical imperative to offer all trial participants (in both experimental and control arms) state-of-the-art HIV prevention information and services, which currently include behavioral risk reduction counseling and the provision of male condoms — and soon may include offering male circumcision. In trial after trial of new HIV prevention technologies, this has been shown to increase protective action (e.g., partner reduction and increased condom use) in both experimental and control arms of the study, thereby making it difficult to observe an independent effect (if there is one) of the product under study. As new strategies are shown to be efficacious and must then be included in the standard of prevention offered in trials, it will become ever-more difficult to ascertain the independent effect of investigational products; and the tension between research ethics and study design will be exacerbated.

Clinical trials resulting in null and negative findings

In recent years, a number of multi-site RCTs of promising biomedical/technological interventions for HIV prevention, such as microbicides, vaccines, and the female diaphragm, have yielded either null or negative findings. That is, there was no difference between experimental and control groups with respect to HIV infection rates or, in a couple of cases, participants in the experimental arm appeared to have higher rates of infection than those in the control arm. Null findings may have been influenced by the standard of prevention mentioned above; and negative findings may be a result of the mechanisms of action of the products under study that did not appear during pre-clinical or Phase I studies.

Both kinds of outcomes raise a host of questions whose answers will affect the ability to conduct future, successful HIV prevention trials, including: how are null and negative findings communicated to and understood by trial participants and other members of their communities? How can expectations about optimal trial results be managed? How, in the face of disappointing — and even harmful — findings, can support for HIV prevention trials be maintained among communities and funders? Does a null result in a large trial of a particular product (e.g., the latex diaphragm) doom that product for any subsequent trials, even if the finding may be a result of uptake of risk reduction behaviors among all trial participants rather than product non-efficacy? If so, will we ever truly be able to know if the product itself is effective; and might we be running the risk of ruling out a potentially efficacious product?

Putting HIV prevention in the larger social context

It is easy for researchers to believe that a clinical trial is the most important thing in a participant's life, since it is the most important thing to the researcher in relation to that participant. In reality, a trial is just one feature of a participant's often complicated life; and it occurs in a social and cultural context that highly influences participants’ daily lives and, ultimately, trial outcomes. For example, although most HIV prevention trials screen out women who are or say they intend to become pregnant during the course of the study, in recent trials, pregnancy rates of 10 — 80 percent have occurred. It is not simply a question of whether women are not being truthful about their intentions during recruitment; rather, such unanticipated pregnancy rates reflect the strong pull of cultural norms about childbearing experienced by women everywhere. Perhaps some women do intend to get pregnant but do not want to miss out on a trial that they think may save their lives. Perhaps they do not intend to get pregnant, but are pressured or coerced into it by their male partners or family members. Intention itself may not be a normative cultural construct. In sum, pregnancy in the context of HIV prevention trials is an expression of the complex operation of gender — a major social organizing principle in all societies — in the calculus of disease prevention and fertility expectations that will continue to make preventing the sexual transmission of HIV infection a formidable challenge.

While these (and other) unresolved issues and complex challenges face us, they do not stymie us. Rather, as this book demonstrates, HIV prevention scientists, community advocates, policy-makers, and funders — individually and collectively — continue to find creative ways to fill knowledge gaps, to protect the rights and improve the health of research participants, and to rally political and financial support for an improved and enhanced response to AIDS. The impact of that response is dependent on a comprehensive, multi-disciplinary view that understands, respects, and knows how to interpret the dynamic interplay of biological, psychological, and social and cultural forces at work everywhere.

About the Editors

Kenneth H. Mayer, MD is Professor of Medicine and Community Health at Brown University, Director of the Brown University AIDS Program, and Attending Physician in the Infectious Disease Division of The Miriam Hospital in Providence, Rhode Island. He is also Medical Research Director at Boston's Fenway Community Health Center, where (since 1983) he has conducted studies of HIV's natural history and transmission. In the early 1980s, as a research fellow studying infectious diseases at Brigham and Women's Hospital, Dr Mayer was one of the first clinical researchers in New England to provide care for patients living with AIDS. In 1983, he co-authored The AIDS Fact Book, one of the first books about AIDS to be written for the general public. In 1984, he began one of the first studies of the natural history of HIV infection, and was subsequently funded by the federal government to study biological and behavioral factors associated with male-to-male HIV transmission. Since 1987, Dr Mayer and his colleagues have been supported by the NIH and CDC to study the dynamics of heterosexual HIV transmission and the natural history of HIV in women, and to study HIV prevention interventions, ranging from vaccines (HIVNET, HVTN) to microbicides, behavioral and other strategies (HPTN). He has been the principal investigator of four Phase I microbicide trials, including the first human trial of Tenofovir gel. He has collaborated with basic virologists and immunologists to more accurately characterize the genetics and immunopathology of HIV disease. In the late 1980s he initiated the first community-based clinical trials for people living with HIV/AIDS in New England, and helped amFAR develop its national Community-Based Clinical Trials Network (CBCTN). He was subsequently elected to the Board of Directors of amFAR and was co-chair of its Clinical Research and Education Committee; he is now a member of their Program Board. He has also served on the national boards of HIVMA and GLMA.

Hank F. Pizer, BA, PA is a medical writer, health-care consultant and physician assistant. He has written and edited 15 books and numerous articles about health and medicine that have been published in English and translated into at least 6 foreign languages. With Kenneth Mayer he co-authored the first book about AIDS for the general public, The AIDS Fact Book (Bantam Books, 1983), and co-edited The Emergence of AIDS: Impact on Immunology, Microbiology, and Public Health (American Public Health Association Press, 2000) and The AIDS Pandemic: Impact on Science and Society (Academic Press, 2005). With Chris Beyrer, he co-edited Public Health and Human Rights: Evidence-Based Approaches (Johns Hopkins University Press, 2007, The Director's Circle Book for 2007) and with Kenneth Mayer, The Social Ecology of Infectious Diseases (Academic Press, 2008), to which he also contributed. His other works cover a variety of subjects in health and medicine, including the first books for the general public on organ transplants (Organ Transplants: A Patient's Guide, with the Massachusetts General Organ Transplant Teams; Harvard University Press, 1991) and stroke (The Stroke Fact Book, with Conn Foley, Bantam Books, 1985; Courage Press and the American Heart Association) and, in women's health, on family planning (The New Birth Control Program, with Christine Garfink, RN, Bolder Books, New York, 1977; Bantam Books, New York, 1979) and parenting (The Post Partum Book, with Christine Garfink, RN, Grove Press, New York, 1979). He is currently co-founder and principal of Health Care Strategies, Incorporated, a consulting firm that provides program evaluation and management consulting services to clients in health and education. From 1984 to 1994 he was founder and President of New England Medical Claims Analysts, Incorporated, a consulting firm that provided cost containment, utilization review and coordination of benefits services to health insurers, health maintenance organizations, union health plans and self-insured companies.

Notes on Contributors

Quarraisha Abdool Karim, PhD, MS is an Associate Professor at the Depar-tment of Epidemiology, Mailman School of Public Health and in the School of Family Medicine and Public Health at the University of KwaZulu-Natal. She is an infectious diseases epidemiologist whose main current research interests are in understanding the evolving HIV epidemic in South Africa; factors influencing the acquisition of HIV infection in young women; and establishing sustainable strategies to introduce HAART in resource-constrained settings. She is Scientific Director of the Centre of the AIDS Programme of Research in South Africa (CAPRISA); Director of the Columbia University–Southern African Fogarty AIDS International Training and Research Programme (CU-SA Fogarty AITRP) and Co-Chair of the HIV Prevention Trials Network Leadership Group (HPTN). Dr Abdool Karim was responsible for establishing the South African National HIV/AIDS and STD Programme shortly after the first democratic elections in South Africa.

Susan Allen, MD MPH, DTM&H is Principal Investigator, Director of the Rwanda-Zambia HIV Research Group (RZHRG), and Professor of Global Health at the Rollins School of Public Health at Emory University, in Atlanta, GA. Dr Allen received her medical degree from Duke University, her Diploma of Tropical Medicine and Hygiene from the Liverpool School of Tropical Medicine, and her Masters in Public Health from the University of California at Berkeley. She founded and directs the Project San Francisco (PSF) in Rwanda (1986) as well as the Zambia-Emory HIV Research Project (ZEHRP) in Lusaka (1994), and Ndola and Kitwe (2004), Zambia. Promoting and expanding access to couples' VCT – which reduces HIV transmission within discordant couples by over 60 percent – is a core aim of RZHRG. Since 2002, 60,000 couples have been tested by RZHRG, and the 4 sites have enrolled and followed over 4000 HIV-discordant couples, making them the largest single-site heterosexual HIV-discordant couples cohorts in the world. In addition to the original studies on HIV disease progression and HIV prevention within discordant couples, all four sites now conduct sophisticated laboratory studies and clinical trials, including HIV vaccine clinical trials sponsored by International AIDS Vaccine Initiative.

Deborah J. Anderson, PhD is a Professor in the Departments of Microbiology and Obstetrics and Gynecology at Boston University School of Medicine, Boston, MA. Her primary research interests are mechanisms of immune defense and infection of genital tract tissues. She has published widely and received numerous awards for her research. Dr Anderson has served on a number of professional committees, and in professional organizations including the World Health Organization Human Reproduction Programme, Family Health International Technical Advisory Board, numerous National Institutes of Health (NIH) Study Sections, and the Scientific Advisory Board of the American Foundation for AIDS Research (AmFar).

Sevgi O. Aral, PhD, MS, MA is the Associate Director for Science in the Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), CDC. In this role, Dr Aral is responsible for the oversight and direction of all scientific activities including the intramural and extramural research programs and science-program interactions. In addition to her appointment at the CDC, Dr Aral has served as a Professor of Sociology in the United States and Turkey. She has served in the role of mentor for both trainees and colleagues needing help with social science perspectives bridging the gap between clinical epidemiology and behavior. She currently serves as a Clinical Professor at the University of Washington School of Medicine. Dr Aral's work has focused on risk and preventive behaviors, gender differences, societal characteristics that influence STD and HIV rates, contextual issues, and effects of distinct types of sexual mixing on STD spread. Her research has been in both domestic and international settings, and her writings have included cross-cultural comparative analyses. Dr Aral is on the editorial boards of several scientific journals, including Sexually Transmitted Diseases, AIDS Education and Prevention, and Sexually Transmitted Infections. In addition, she is the Associate Editor of Sexually Transmitted Diseases and Sexually Transmitted Infections. In the past she has served multiple terms on the editorial boards of AIDS and the American Journal of Public Health. Dr Aral received her PhD and MA in Social Psychology from Emory University, and another MA in Demography from the University of Pennsylvania. She received her undergraduate degree from the Middle East Tech University in Turkey.

Judith D. Auerbach, Ph.D. Dr. Judith Auerbach is Deputy Executive Director for Science and Public Policy at the San Francisco AIDS Foundation (SFAF), where she is responsible for developing, leading, and managing SFAF's local, state, national, and international science and policy agenda. Prior to joining SFAF, Dr. Auerbach served as Vice President, for Public Policy and Program Development, at amfAR (The Foundation for AIDS Research) and as Director of the Behavioral and Social Science Program and HIV Prevention Science Coordinator in the Office of AIDS Research at the National Institutes of Health (NIH). Dr. Auerbach received her Ph.D. in sociology from the University of California, Berkeley and taught sociology at Widener University and the University of California, Los Angeles. She has published and presented in the fields of AIDS, health research and science policy, and family policy and gender, and serves on numerous professional and advisory groups, including the Council of the American Sociological Association the Global HIV Prevention Working Group, and the NIH/OAR Microbicides Research Working Group.

Stefan Baral, MD, MPH, MBA, MSc is a resident physician at the University of Toronto and a Post-Doctoral Fellow at the Center for Public Health and Human Rights in the Department of Epidemiology, at the Johns Hopkins School of Public Health. He completed his undergraduate degree specializing in immunology and microbiology at McGill University and then went on to graduate school at McMaster University researching novel molecular vaccination strategies. His medical school training was completed at Queen's University, with a focus in both public health and global health disparities. Dr Baral then pursued further graduate training at the JHSPH, specializing in epidemiology and non-profit health-care management. Since graduating, Stefan has joined the IDU Working group of the HIV Vaccine Trial Network, which is focused on designing and launching HIV Vaccine trials among injecting drug users. In addition, he has spent the last few years evaluating and reviewing the HIV epidemic among MSM in lower-income settings. Most recently, he has designed and is helping to coordinate, in equal partnership with local LGBT community groups, a multicenter cross-sectional probe of HIV prevalence, determinants of infection, and human rights contexts of MSM in four sites across Southern Africa. Dr Baral maintains a clinical practice serving the needs of at risk populations in Toronto, and has provided care in settings ranging from methadone clinics and homeless shelters in Canada to large tertiary-care institutions in Kampala.

Jane T. Bertrand, PhD, MBA is currently Director of the Center for Communication Programs (CCP) and Professor, Department of Health, Behavior & Society, at the Johns Hopkins Bloomberg School of Public Health. Prior to moving to Hopkins in 2001, Dr Bertrand was on the faculty at the Tulane University School of Public Health and Tropical Medicine, where she chaired the Department of International Health and Development from 1994 to 1999 and served as PI for the Tulane subcontract under the EVALUATION Project (1991–1996) and the MEASURE Evaluation Project (1996–2001). Dr Bertrand focused on information–education–evaluation for family planning in the 1970s, on operations research during the 1980s, and on program evaluation in the 1990s. Since joining Hopkins in 2001, she has been able to combine these interests (e.g., in publishing on the effects of communication programs on behavior change in HIV programs and teaching a highly subscribed course on fundamentals of program evaluation). She has published over 60 articles, a dozen technical manuals, and two books. Recent publications include a manual on Evaluating HIV/AIDS Prevention Programs with a Focus on NGOs and Strategic Communication in the HIV/AIDS Epidemic. She has worked extensively in Guatemala, the Democratic Republic of the Congo, and Morocco, as well as on short-term assignments in over 30 countries, being fluent in French and Spanish.

Chris Beyrer, MD, MPH is Professor of Epidemiology, International Health and Health, Behavior and Society at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. He serves as Director of Johns Hopkins Fogarty AIDS International Training and Research Program, and as Director of the Center for Public Health and Human Rights. Dr Beyrer is Associate Director for the School of Public Health of the new Johns Hopkins Center for Global Health. He currently serves as Co-Chair of the Injecting Drug Use Working Group of the HIV Vaccine Trials Network and a Senior Scientific Liaison for the HVTN. He has extensive experience in conducting international collaborative research and training programs in HIV/AIDS and other infectious disease epidemiology, in infectious disease prevention research, HIV vaccine preparedness, in health and migration, and in health and human rights. He is the author of the 1998 book War in the Blood: Sex Politics and AIDS in Southeast Asia and co-editor of the 2007 book Public Health and Human Rights: Evidence-Based Approaches. Dr Beyrer currently serves as a member of the Global Health Advisory Council of the Open Society Institute, as a trustee of the Institute for Asian Democracy, and as advisor to the International Partnership for Microbicides and the HIV Vaccine Trials Network. He has previously served as advisor to the US CDC, the Office of AIDS Research of the US NIH, the US Military HIV Research Program, the World Bank Institute, the World Bank Thailand Office, the Royal Thai Army Medical Corps and the Thai Red Cross, as well as numerous other organizations.

David Cohen, BS is a research assistant in the Department of Medicine, Division of Infectious Diseases at The Miriam Hospital and the Center for Prisoner Health and Human Rights. He graduated in 2004 with a degree in electrical engineering from Yale University, and worked for the MIT Lincoln Laboratory from 2004 to 2006 as an electrical/aerospace engineer before switching to the field of medicine. He begins the Alpert Medical School of Brown University in the fall of 2008, and is looking forward to embarking on a career in medicine.

Myron S. Cohen is J. Herbert Bate Distinguished Professor of Medicine, Microbiology and Immunology and Public Health at the University of North Carolina at Chapel Hill, Director of the UNC Division of Infectious Disease and UNC Institute for Global Health and Infectious Disease, Associate Vice Chancellor for Medical Affairs-Global Health and Associate Director of the UNC Center for AIDS Research. He serves on the Senior Leadership Group of the NIH Center for HIV Vaccine Immunology (CHAVI) and the leadership group of the NIH HIV Prevention Trials Network (HPTN). He is an Associate Editor of the journal Sexually Transmitted Diseases and the Editor of the comprehensive textbook, Sexually Transmitted Diseases. In 2005, he received an NIH MERIT Award for ongoing support of his work in HIV transmission and prevention which focuses on the role played by STD co-infections and the use of antiretroviral agents in HIV prevention. He is the author of more than 400 publications. Dr. Cohen received his Bachelor of Science Magna Cum Laude from the University of Illinois, medical degree from Rush Medical College and completed an Infectious Disease Fellowship at Yale University.

Grant N. Colfax, MD is Director of HIV Prevention and Research, San Francisco Department of Public Health. He received his MD degree at Harvard Medical School and completed his residency in Internal Medicine at the University of California, San Francisco. Dr Colfax is an expert on substance use and HIV risk, with most of his research focusing on non-injection substance use and sexual risk among men who have sex with men. Most recently, his research has focused on testing pharmaceutical agents to treat methamphetamine dependence. As HIV Prevention Director, he oversees a program that funds 32 community-based agencies delivering HIV prevention services to San Francisco's diverse communities. He is the author of numerous peer-reviewed papers on substance use, HIV risk, and prevention interventions.

Gina Dallabetta, MD joined the Bill & Melinda Gates Foundation in January 2005 as a Senior Program Officer on the India AIDS Initiative, Avahan. Avahan is an HIV prevention intervention working with populations most at risk in six states in India. Dr Dallabetta brings over 15 years of experience in HIV programming to Avahan, of which 13 years were spent at the Family Health International (FHI). Prior to joining the foundation, Gina was Director of the Prevention Department of the HIV/AIDS Institute of FHI based in Arlington, Virginia. The Department was responsible for sexually transmitted infections (STI), behavior-change communication, monitoring and evaluation, and related operations research in FHI activities in over 40 countries in Asia, Africa, Latin America, the Caribbean, Eastern European and the Middle East.Anjana Das, MBBS, DCH works as Senior Technical Officer with Family Health International, India. She is a member of the STI Capacity Building team of the India AIDS Initiative (Avahan) program supported by the Bill & Melinda Gates Foundation. She is a clinician who has worked on HIV prevention and STI programs for sex workers and their clients for the past 4 years.

Julie A. Denison, PhD is a scientist with Family Health International's Behavioral and Biomedical Research Division. Dr Denison received her doctoral degree from The Johns Hopkins University, Bloomberg School of Public Health. She has conducted international research to examine the role of families in the provision of HIV testing and counseling for young people in sub-Saharan Africa. Dr Denison has also published a meta-analysis of the effectiveness of voluntary counseling and testing as a behavior-change strategy in developing countries.

Lydia N. Drumright, PhD, MPH is a research fellow at the University of California, San Diego, Department of Family and Preventive Medicine, Division of International Health and Cross-Cultural Medicine. She received her BSc in Biochemistry and Cellular Biology from the University of California, San Diego (UCSD), Masters in Public Health in Health Education from California State University, Northridge, and PhD in Epidemiology from (UCSD). For the past 10 years Dr Drumright has worked extensively on risk behaviors associated with acquisition and transmission of sexually transmitted infections among adolescents and men who have sex with men (MSM). Most recently, her work has focused on non-injection substance use and HIV acquisition and transmission among MSM with acute and early HIV infection.

Ann Duerr, MD, MPH, PhD received her BSc from McGill University, her PhD from the Massachusetts Institute of Technology, and her MD cum laude from Harvard Medical School. She then completed a Preventive Medicine Residency at the Johns Hopkins School of Hygiene. Dr Duerr joined the US Centers for Disease Control (CDC) in 1991 as Chief of the HIV Section in the Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion. Under her direction, the HIV section expanded and developed a domestic and international research portfolio related to HIV and reproductive health of women. At the CDC Dr Duerr led the development of several notable multinational efforts, including: (1) the HIV Epidemiology Research Study (HERS), (2) research to increase awareness of refugee women's health, (3) the investigation of HIV transmission in Thai couples, (4) an initiative on microbicide research, and (5) the ongoing Breastfeeding Antiretrovirals Nutrition (BAN) trial. Dr Duerr has received numerous honors, including the Surgeon General's Exemplary Service Award, and the Public Health Service Special Recognition Award; she has served as a consultant to the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). Since 2003, Dr Duerr has been the Associate Director of the HIV Vaccine Trials Network (HVTN) in Seattle, WA. She is the author of over 100 peer-reviewed publications, and in 1995 co-edited a book entitled HIV Infection in Women.

Kevin A. Fenton, MD, PhD is Director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) at the US Centers for Disease Control and Prevention (CDC). He received his medical undergraduate degree at the University of the West Indies (Mona), his postgraduate training in Public Health Medicine at the London School of Hygiene and Tropical Medicine, Royal Free and University College Medical School, and his PhD in Epidemiology from the University of London. Prior to his work at the CDC, Dr Fenton was the Director of the HIV and Sexually Transmitted Infections Department in the United Kingdom's Health Protection Agency (HPA). He has published numerous book chapters and peer-reviewed articles on HIV and STD epidemiology, policy and sexual behavior, with a special emphasis on racial and ethnic health disparities. Dr Fenton is a Fellow of the Faculty of Public Health of the Royal Colleges of Physicians of the United Kingdom, and a Visiting Professor at University College London.

Chandra Ford is in the Department of Epidemiology at the Mailman School of Public Health at Columbia University, where she is a postdoctoral fellow in the Multidisciplinary Track of the Kellogg Health Scholars Program. Before arriving to Columbia, Dr Ford was a postdoctoral fellow in the Department of Social Medicine in the School of Medicine at the University of North Carolina, where she earned her PhD. She also holds an MPH in Health Services Administration and a Master's in Library and Information Sciences with a concentration in Health Information from the University of Pittsburgh. She has developed expertise in the study of individual (e.g., perceived racism), interpersonal (e.g., patient–provider interactions) and structural (e.g., residential segregation) factors relative to racial and ethnic disparities in HIV/AIDS.

Mark S. Friedman, PhD is an Assistant Professor in the Department of Behav-ioral and Community Health Sciences, Graduate School of Public Health, University of Pittsburgh. Dr Friedman received his PhD in Social Work from the University of Pittsburgh. His publications have focused on defining and measuring sexual orientation; the relationship between gender-role non-conformity, bullying and suicidality among gay youth; and antecedents of adult health problems among gay males. Dr Friedman was recently awarded a grant from the National Institute of Mental Health to develop Internet-based interventions for gay youth.

Crystal M. Fuller, PhD is an Associate Professor of Epidemiology at the Mailman School of Public Health at Columbia University and also serves as a Senior Epidemiologist at the Center for Urban Epidemiologic Studies at the New York Academy of Medicine. Dr Fuller's work has largely focused on HIV prevention and intervention research among drug users and other marginalized populations in low-income, urban communities. She has directed several federally funded, large-scale public health program and policy evaluation studies examining their impact on reducing individual and community-wide disease rates, particularly in communities where racial disparities persist. Dr Fuller also has extensive experience in the design and conduct of large cross-sectional and cohort studies, including community-based multilevel intervention trials, often utilizing a community-based participatory research approach targeting adolescent and young adult injection and non-injection drug users.

Cynthia L. Gay, MD, MPH is a Clinical Assistant Professor and Infectious Diseases Specialist at the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. She is a graduate from the University of North Carolina at Chapel Hill School of Medicine, and completed her internal medicine residency at Vanderbilt Medical Center. She obtained a MPH and completed an Infectious Diseases Fellowship at the University of North Carolina at Chapel Hill. She has provided clinical care and conducted HIV-related research in several African settings.

Robert E. Geise, MD, MPH is a Clinical Assistant Professor of Medicine at the University of Washington in the Division of Infectious Diseases and a Protocol Team Leader at the HIV Vaccine Trials Network (HVTN). Dr Geise completed his undergraduate education at Cornell University and completed an MBA in Finance at the University of Wisconsin. After 5 years in business, Dr Geise received his MD at the Medical College of Virginia. He was a Resident and Chief Resident in Medicine at the George Washington University, and completed an infectious disease fellowship at the University of Washington. He has done research in primary HIV infection, antiretroviral therapy (ART) and HIV vaccines.

Glenda E. Gray, FCP(SA) (Paeds) is an Associate Professor in Pediatrics and the co-founder and co-Executive Director for the Perinatal HIV Research Unit, based at the Chris Hani Baragwanath Hospital, and affiliated to the University of the Witwatersrand. Professor Gray has been an investigator in the field of mother-to-child transmission of HIV since 1993. She helped with the development of clinical infrastructure necessary to conduct trials across the spectrum of HIV care, prevention and treatment, including prevention of mother-to-child transmission, adult and pediatric treatment, HIV prevention, and trials of candidate HIV vaccines in Soweto, South Africa. She was awarded a Fogarty Training Fellowship at Columbia University in 1999, and completed an intensive program on clinical epidemiology at Cornell University. Evidence of the quality and significance of her work includes numerous peer-reviewed publications, invited lectures in national and international settings, and leadership roles in both the HVTN and IMPAACT. Professor Gray, together with James McIntyre, was awarded the 2002 Nelson Mandela Award for Health and Human Rights, in recognition of their research and advocacy work in the field of PMTCT. In 2004, together with McIntyre, Gray was awarded the IAPAC Hero in Medicine Award. She is a member of the Academy of Science of South Africa.

Ronald Gray, MBBS, MSc is the Robertson Professor of Reproductive Epidemiology at the Johns Hopkins University, Bloomberg School of Public Health. He is an epidemiologist and was the principal investigator on the trial of male circumcision for HIV prevention in men. He is co-principal investigator on the Rakai Health Sciences Program, and has conducted several studies of male circumcision for HIV prevention. Dr Gray has published over 300 papers on reproductive health and HIV.

Amy Gregowski, MHS, is a Research Associate in the Department of International Health, Social and Behavioral Interventions Program. She received her Master's degree from the Johns Hopkins Bloomberg School of Public Health. She is currently working on two HIV prevention projects funded by the US National Institutes of Health: one is in Vietnam with men who are HIV-positive and injection drug users, and the other is a multisite study in several countries in sub-Saharan Africa and Thailand.

Thomas E. Guadamuz, PhD., MHS is a postdoctoral fellow in the Department of Behavioral and Community Health Sciences and the Center for Research on Health and Sexual Orientation, Graduate School of Public Health, University of Pittsburgh. Dr Guadamuz received his PhD in Infectious Disease Epidemiology from The Johns Hopkins University, and has received NIH Fogarty and Fulbright fellowships to conduct HIV prevention research among MSM populations in Thailand. Most recently, Dr Guadamuz was a member of the Thailand MSM Study Group, where he collaborated with investigators from the US CDC, Thailand Ministry of Public Health and Rainbow Sky Association of Thailand (the first and largest Thai MSM community-based organization) to carry out the first HIV surveillance among MSM populations in Thailand.

Kathy Hageman, MPH is currently pursuing a PhD in Behavioral Science and Health Education at Emory University in Atlanta, Georgia. Ms Hageman has recently been awarded a Ruth L. Kirschstein National Research Service Awards (NRSA) Pre-Doctoral Fellowship to investigate the behavioral barriers (individual, couple, and socio-cultural) that prevent consistent and correct condom use within long-term HIV-discordant relationships, and how these barriers can be overcome. Collaborating with the two largest HIV-discordant research sites in the world, in Lusaka (Zambia) and Kigali (Rwanda), this study aids in the refinement of risk-reduction counseling messages and intervention development for this high-risk yet understudied population.

Abigail Harrison PhD is Assistant Professor (Research) at the Population Studies and Training Center, and Instructor, Department of Medicine, Warren Alpert Medical School, Brown University. She is a social demographer whose research examines HIV prevention in adolescents, gender and reproductive health, and the social and cultural processes underlying health outcomes. Her current research focuses on adolescent sexual behavior and the transition to adulthood in South Africa, as well as behavioral interventions for this population.

Amy Herrick, MA is currently a doctoral student in the Department of Behavioral and Community Health Sciences, Graduate School of Public Health at the University of Pittsburgh. She received a Master of Arts in Social Science from the University of Chicago in 2001, with a focus on sociology of gender. Using primarily a community-based approach, Amy has been working with the sexual minority youth community for the past 15 years. Amy's current research interests focus on the health disparities of young women who have sex with women, and HIV risk behaviors of transgender youth and young men who have sex with men.

Donna L. Higgins, PhD is a Technical Officer with the HIV/AIDS Department at the World Health Organization (WHO). Dr Higgins is responsible for leading WHO's global HIV testing and counseling program, and has provided program and evaluation support on the topic in multiple developing countries. Dr Higgins has expertise in the development, implementation and evaluation of individual-, group- and community-level HIV prevention strategies. Prior to working at the WHO, Dr Higgins served at the US Centers for Disease Control and Prevention.

David R. Holtgrave, PhD has since August 2005 been Professor and Chair of the Department of Health, Behavior and Society at Johns Hopkins Bloomberg School of Public Health. From 2001 to 2005, Dr Holtgrave was Professor of Behavioral Sciences and Health Education, and Professor of Health Policy and Management at Rollins School of Public Health at Emory University. He served as Director of Behavioral & Social Science Core of the Center for AIDS Research (CFAR) and Vice-Chair of the Department of Behavioral Sciences and Health Education. From 1997 to 2001, Dr Holtgrave was Director of the Division of HIV/AIDS Prevention: Intervention Research and Support in the National Center for HIV, STD and TB Prevention at the Centers for Disease Control and Prevention. The Division has major responsibilities in funding HIV prevention programs, providing technical assistance to HIV prevention service delivery organizations, conducting program evaluation studies, and performing HIV prevention intervention research. Dr Holtgrave has worked in the field of HIV prevention since 1991. From 1991 until 1995 and from 1997 to 2001, he worked at the CDC in HIV prevention; from 1995 until 1997 he was an Associate Professor and Associate Center Director at the Center for AIDS Intervention Research at the Medical College of Wisconsin. His research focuses on the effectiveness and cost-effectiveness of a variety of HIV prevention interventions, and the relation of the findings of these studies to HIV prevention policy-making. Dr Holtgrave worked on HIV prevention community planning, and on the Wisconsin HIV Prevention Community Planning group.

Angela D. Kashuba, BScPhm, PharmD, DABCP is an Associate Professor in the Division of Pharmacotherapy and Experimental Therapeutics at the University of North Carolina School of Pharmacy. She is the Director of the UNC Center of AIDS Research Clinical Pharmacology and Analytical Chemistry Core, and Director of the Analytical Chemistry Laboratory for the Verne S. Caviness General Clinical Research Center. She has worked extensively on characterizing the pharmacology of small molecules in the genital tract of men and women to inform primary and secondary HIV prevention strategies.

Godfrey Kigozi, MBChB is the senior Medical Officer for the Rakai Health Sciences Program, and was responsible for the conduct of the trials of male circumcision for HIV prevention in Rakai, Uganda. He has been first author and co-author on several papers describing the trials of male circumcision in Rakai.

Marie Laga, MD, MSc, PhD is Professor and Head of HIV/STI Epidemiology and Control Unit at the Institute of Tropical Medicine (ITM) in Antwerp Belgium. M. Laga started working on HIV/AIDS in 1984 and spent several years overseas in Burundi, Kenya, DR Congo, the UK (training at LSHTM), the US (Visiting Scientist in the AIDS program at the CDC) and in Côte d'Ivoire (as Director of Projet Retro-CI, a large CDC-funded HIV/AIDS research and intervention program). Current HIV/AIDS activities include policy support and operational research in the areas of expansion of care and strengthening prevention strategies in developing countries, as well as development of applied training modules for HIV/AIDS control program managers. Marie Laga is author of over 140 scientific publications on different aspects of HIV AIDS in developing countries.

Cynthia M. Lyles, PhD is a mathematical statistician and Team Leader of the Research Synthesis and Translation Team within the Prevention Research Branch for the Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), CDC. She received two Bachelor's degrees in Mathematics and Math-education from the University of South Florida, and her MS and PhD in Biostatistics from the University of North Carolina at Chapel Hill. While at The Johns Hopkins University, and currently at CDC, Dr Lyles has worked on domestic and international HIV epidemiology and behavioral prevention research across a range of risk populations. She has published numerous peer-reviewed articles on HIV epidemiology and behavioral prevention research. Dr Lyles has served as a consulting editor of Health Psychology for the evidence-based medicine and methodology section.

Ian McGowan, MD, PhD, FRCP is a Professor of Medicine at the Magee Womens Research Institute at the University of Pittsburgh, Pittsburgh, Pennsylvania. He graduated in Medicine from the University of Liverpool, and obtained his PhD from the University Of Oxford, England. He completed postgraduate training in HIV medicine and gastroenterology. After working in the pharmaceutical industry on the development of a number of antiretroviral drugs, including Viread®, Dr McGowan returned to academic research. He worked at the David Geffen School of Medicine at UCLA for 5 years, and has recently moved to the University of Pittsburgh. His research interests focus on clinical and translational aspects of microbicide development, with a specific focus on rectal microbicide development. Dr McGowan is the Co-Principle Investigator of the NIH funded Microbicide Trials Network, and is a member of the Antiviral Advisory Committee of the United States Food and Drug Administration.

James A. McIntyre, FRCOG is the co-founder and an Executive Director