Reducing the Odds

Preventing Perinatal Transmission of HIV In The United States

Michael A. Stoto, Donna A. Almario, and Marie C. McCormick, Editors

Committee on Perinatal Transmission of HIV

Division of Health Promotion and Disease Prevention,

Institute of Medicine, and

Board on Children, Youth, and Families,

Commission on Behavioral and Social Sciences and Education,

National Research Council and Institute of Medicine

NATIONAL ACADEMY PRESS
Washington, D.C.
1999



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--> Reducing the Odds Preventing Perinatal Transmission of HIV In The United States Michael A. Stoto, Donna A. Almario, and Marie C. McCormick, Editors Committee on Perinatal Transmission of HIV Division of Health Promotion and Disease Prevention, Institute of Medicine, and Board on Children, Youth, and Families, Commission on Behavioral and Social Sciences and Education, National Research Council and Institute of Medicine NATIONAL ACADEMY PRESS Washington, D.C. 1999

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--> NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, DC 20418 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. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under the Academy’s 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this study was provided by the Department of Health and Human Services and the Centers for Disease Control and Prevention (Contract No. 200-97-0651). Library of Congress Cataloging-in-Publication Data Reducing the odds : preventing perinatal transmission of HIV in the United States / Michael A. Stoto, Donna A. Almario, and Marie C. McCormick, editors ; Committee on Perinatal Transmission of HIV, Division of Health Promotion and Disease Prevention, Institute of Medicine [and] Board on Children, Youth, and Families, Commission on Behavioral and Social Sciences and Education, National Research Council, Institute of Medicine. p. cm. Includes bibliographical references and index. ISBN 0-309-06286-1 1. AIDS (Disease) in pregnancy—United States. 2. AIDS (Disease)in infants—United States—Prevention. 3. HIV infections—United States—Prevention. 4. AIDS (Disease) in women—Treatment—United States. I. Stoto, Michael A. II. Almario, Donna A. III. McCormick, Marie C. IV. Institute of Medicine (U.S.). Committee on Perinatal Transmission of HIV. V. Board on Children, Youth, and Families (U.S.) RG580.A44 R43 1998 618.3—dc21 98-40214 Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Lock Box 285, Washington, DC 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area). This report is also available online at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www2.nas.edu/iom. Copyright 1999 by the National Academy of Sciences. All Rights Reserved. Printed in 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 image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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--> Committee On Perinatal Transmission Of HIV Marie McCormick, M.D., Sc.D. (Chair), * Professor and Chair, Department of Maternal and Child Health, Harvard School of Public Health Ezra Davidson, Jr., M.D. (Vice Chair), * Associate Dean, Primary Care, and Professor of Obstetrics and Gynecology, Charles R. Drew University of Medicine and Science Fred Battaglia, M.D., * Professor of Pediatrics and of Obstetrics and Gynecology, Division of Perinatal Medicine, University of Colorado Health Sciences Center Ronald Brookmeyer, Ph.D., Professor of Biostatistics, Johns Hopkins School of Public Health Deborah Cotton, M.D., M.P.H., Professor of Medicine and Public Health; Director, Office of Clinical Research; and Assistant Provost of the Boston University Medical Center Susan Cu-Uvin, M.D., Assistant Professor of Obstetrics and Gynecology, The Miriam Hospital, Brown University Nancy Kass, Sc.D., Associate Professor and Director, Program in Law, Ethics, and Health, Johns Hopkins School of Public Health Patricia King, J.D., * Professor of Law, Medicine, Ethics, and Public Policy, Georgetown University Law Center Lorraine Klerman, Dr.P.H., Professor, Department of Maternal and Child Health, School of Public Health, University of Alabama at Birmingham Katherine Ruiz de Luzuriaga, M.D., Associate Professor of Pediatrics, University of Massachusetts Medical School Ellen Mangione, M.D., M.P.H., Director, Disease Control and Environmental Epidemiology Division, Colorado Department of Public Health and Environment, Denver Douglas Morgan, M.P.A., ** Assistant Commissioner, Division of AIDS Prevention and Control, New Jersey Department of Health and Senior Services, Trenton Stephen Thomas, Ph.D., Director, Institute for Minority Health Research, and Associate Professor of Community Health, Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University Sten Vermund, M.D., Ph.D., Professor, Department of Epidemiology, School of Public Health, University of Alabama at Birmingham *   Institute of Medicine member. **   Resigned April 1998, upon appointment to the Division of Service Systems, HIV/AIDS Bureau, Health Resources and Services Administration.

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--> Liaison to the Board on Health Promotion and Disease Prevention Robert Fullilove, Ed.D., Associate Dean for Community and Minority Affairs, Columbia University School of Public Health Project Staff Michael Stoto, Study Director Donna Almario, Project and Research Assistant Kathleen Stratton, Director, Division of Health Promotion and Disease Prevention Donna Duncan, Division Assistant Staff Consultants David Abramson, Senior Research Analyst, Joseph L. Mailman School of Public Health of Columbia University Barbara Aliza, Health Policy Consultant Miriam Davis, Medical Writer and Consultant Rebecca Denison, Executive Director, Women Organized to Respond to Life-threatening Diseases Amy Fine, Health Policy and Program Consultant Maria Hewitt, Analyst, Institute of Medicine

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--> Liaison Panel A. Cornelius Baker, Executive Director, National Association of People with AIDS Guthrie Birkhead, M.D., M.P.H., Director, AIDS Institute Executive Office, New York State AIDS Institute (representing the Council of State and Territorial Epidemiologists) Patricia Fleming, Ph.D., Chief, Reporting and Analysis Section, Surveillance Branch, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention Michael Greene, M.D., Director of Maternal-Fetal Medicine, Vincent Memorial Obstetrics Division, Massachusetts General Hospital (representing the American College of Obstetricians and Gynecologists) Leslie Hardy, M.H.S., Senior Policy Analyst, Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services Karen D. Hench, R.N., M.S., Nurse Consultant, Maternal and Child Health Bureau, HIV/AIDS Bureau, Health Resources and Services Administration Rosemary Johnson, Outreach Worker, Division of Gynecology and Obstetrics, School of Medicine, Johns Hopkins University Michael Kaiser, M.D., Chief, Comprehensive Family Services Branch, HIV/AIDS Bureau, Health Resources and Services Administration Joseph Kelly, Deputy Director, National Alliance of State and Territorial AIDS Directors Miguelina Maldonado, M.S.W., Director of Government Relations and Policy, National Minority AIDS Council Dorothy Mann, Executive Director, The Family Planning Council of Southeastern Pennsylvania (representing the AIDS Policy Center for Children, Youth and Families) James McNamara, M.D., Chief, Pediatric Medicine Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health Lynne Mofenson, M.D., Associate Branch Chief for Clinical Research, Pediatric, Adolescent, and Maternal AIDS Branch, National Institute of Child Health and Human Development, National Institutes of Health Martha Rogers, M.D., Associate Director for Science, National Center for HIV, STD, and TB Prevention, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention Shepherd Smith, The Children's AIDS Fund Deborah Klein Walker, Ed.D., Assistant Commissioner, Bureau of Family and Community Health, Massachusetts Department of Public Health (representing the Association of Maternal and Child Health Programs)

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--> Catherine Wilfert, M.D., Scientific Director, Elizabeth Glaser Pediatric AIDS Foundation (representing the American Academy of Pediatrics) Pascale Wortley, M.D., Medical Officer, National Center for HIV, STD, and TB Prevention, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention Deborah von Zinkernagel, R.N., S.M., M.S., Senior Policy Analyst, Office of HIV/AIDS, Department of Health and Human Services

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--> Preface The 1994 results of the AIDS Clinical Trials Group protocol number 076 (ACTG 076)—showing that the transmission of HIV from mothers to their children could be substantially reduced through the use of zidovudine (ZDV) by the mother during pregnancy and labor and in the newborn—represented one of the most important successes in the fight against AIDS. These findings led government agencies and professional organizations to propose and implement recommendations calling for counseling and testing all pregnant women for HIV, mostly on a voluntary basis. And as indicated in this report, this approach has been substantially successful. Yet despite the progress, more children than necessary continue to be born with HIV infection. In response to a congressional mandate to "conduct an evaluation of the extent to which State efforts have been effective in reducing the perinatal transmission of the human immunodeficiency virus, and an analysis of the existing barriers to the further reduction in such transmission," this report addresses ways to increase prenatal testing, improve therapy for HIV-infected women and children, and generally reduce perinatal HIV infections. The report also considers the ethical and public health issues associated with screening policies as prevention tools, and their implications for prevention and treatment opportunities for women and infants. The committee recognizes that screening and treating pregnant women is but one strategy among many to prevent perinatal transmission of HIV. The Institute of Medicine (IOM) has dealt with many issues in the primary prevention of HIV, as referenced in this report. The committee also emphasizes the connection between substance abuse and HIV infection in women as a factor in the perinatal transmission of HIV. More specific recommendations about the prevention and

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--> treatment of substance abuse are beyond the scope of this report. Likewise, one strategy for reducing perinatal transmission is to reduce the number of HIV-infected women who become pregnant unintentionally. The consequences and prevention of unintended pregnancy have also been examined recently by the IOM (IOM, 1995b). However, improved planning of pregnancy among HIV-infected women assumes that women know their HIV status. For many women, especially low-income women, pregnancy may be a major opportunity for contact with the health care system. Thus access to care, the potential for ready implementation of screening along with other prenatal testing, and the availability of therapy to improve the outcomes of both mothers and infants in the face of HIV infection, all have led the committee to focus on this episode of care. There are three additional issues related to HIV testing and perinatal transmission that are outside the committee's charge, and hence not dealt with in this report, except as they relate to preventing perinatal transmission. First, mandatory newborn testing, which is the law in New York State (see Appendixes C and L), and which could be the result of the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act Amendments of 1996, has limited utility in preventing perinatal transmission of HIV. While there may be some benefits to the HIV-infected children that would otherwise not be identified (as discussed in Chapter 4), the public health goals behind newborn testing can be better served by improved efforts to prevent transmission, as outlined in this report. Second, perinatal transmission of HIV is a major concern in many developing countries that do not have the resources to implement the ACTG 076 regimen. To address this, there have been efforts to test less expensive approaches through randomized trials in the affected countries, and these trials have been criticized on ethical grounds (Lurie and Wolfe, 1997). Because this issue is outside the committee's charge, which relates to preventing perinatal transmission in the United States, the committee has not addressed this issue. Third, a number of states have recently instituted a policy of named HIV reporting, and others are considering doing the same. Although this approach has important surveillance benefits, it has been criticized on human rights grounds (Gostin et al., 1997; ACLU, 1997). Since it is not clear that instituting this policy has any impact on women's willingness to be tested as a routine part of prenatal care, the committee takes no position on named HIV reporting. To carry out this report, the Institute of Medicine established a committee of 13 individuals, with expertise in pediatrics, obstetrics and gynecology, preventive medicine, women's health, and other relevant medical specialties; social and behavioral sciences; public health practice; epidemiology; program evaluation; health services research; bioethics; and public health law. In keeping with IOM policies, the committee members were chosen to encompass a variety of different perspective and areas of expertise on the issues. The committee met on five occasions between December 1997 and June 1998, sponsored two workshops, conducted five site visits, and commissioned a series of papers, as described in Chapter 1.

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--> The committee was aided in its work by a liaison panel of 19 individuals representing federal agencies, professional organizations, and other groups interested and knowledgeable about perinatal transmission of HIV. The liaison panel members and their affiliations are listed after the committee members on pages v and vi. The liaison panel members participated in the first committee meeting and two workshops, contributed information to the committee, and had an opportunity to review and comment on the workshop summaries and site visit reports. The liaison panel members did not, however, contribute to or review the committee's conclusions and recommendations. The committee is very grateful for the information and ideas that the liaison panel members contributed to this project. 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 (NRC) Report Review committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making the 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 participation in the review of this report: Mary Ellen Avery, The Children's Hospital, Boston; Charles Carpenter, Boston University; Wendy Craytor, Alaska Department of Health and Social Services; James Curran, Emory University; Jill DeBoer, Minnesota Department of Health; Amitai Etzioni, The George Washington University; Fernando Guerra, San Antonio Metropolitan Health District; Luigi Mastroianni, Hospital of the University of Pennsylvania; C. Arden Miller, University of North Carolina at Chapel Hill; Nancy Padian, University of California at San Francisco School of Medicine; and Eugene Washington, University of California at San Francisco. The committee is also thankful for the efforts of the individuals listed in the appendixes who helped to organize and participated in the committee site visits. We would especially like to thank those women, not named for reasons of confidentiality, who were willing to share their personal experience with prenatal HIV counseling and testing and in some cases treatment. Their stories, which appear in the appendixes as well as the body of the report, were extremely helpful to the committee. We would also like to express our gratitude to the individuals, also listed in the appendixes, who gave of their time to participate in the committee's workshops, especially those who were able to make presentations. The site visits and workshops were especially valuable in giving the committee access to the practical issues facing providers and patients dealing with perinatally transmitted HIV. In addition to those who were able to attend the committee's activities in person, many individuals contributed information—ranging from data on prenatal testing in their state to their perspectives on the issues—by e-mail, fax, and phone. Some of this information is cited in relevant parts of the report, but it all

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--> was helpful in formulating our approach to the issues, and we are grateful for the effort that these individuals made. Finally, the committee would like to thank sincerely the IOM staff and consultants who made its work possible. Barbara Aliza, Miriam Davis, Amy Fine, and Maria Hewitt served as consultants to the committee, attended workshops and site visits and summarized the results, prepared special analyses, and helped to draft sections of the report. Donna Almario was an unusually effective research assistant, and served simultaneously as the committee's project assistant, getting everyone to the right place, with the right information, at the right time. Finally, the committee is enormously grateful to Michael Stoto without whose energy and expertise the report would never have been completed in such a prompt fashion. MARIE C. MCCORMICK CHAIR

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--> Contents     Executive Summary   1 1   Introduction   15     The Ryan White CARE Act Amendments of 1996,   16     Organization of the Report,   17     The Committee's Approach,   19 2   Public Health Screening Programs   21     Screening Programs: A Public Health Paradigm,   22     Experience with Selected Public Health Screening Programs,   25     HIV Testing and Screening in the United States,   30     Conclusions,   35 3   Descriptive Epidemiology of the Perinatal Transmission of HIV   36     HIV/AIDS Surveillance Data,   36     HIV and AIDS in Women,   38     Perinatally Transmitted AIDS,   39 4   Natural History, Detection, and Treatment of HIV Infection in Pregnant Women and Newborns   45     Timing of HIV Transmission,   45     Factors Associated with HIV Maternal—Child Transmission,   46     Strategies to Prevent Perinatal HIV Transmission,   47     Diagnosis of HIV Infection in Women and Infants,   51     Summary,   53

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--> 5   Context of Services for Women and Children Affected by HIV/AIDS   54     Community-Level Sources of Care for Women, Children, and Adolescents,   56     Financing Health Care Services for Women, Children, and Adolescents,   57     Organizations Responsible for Developing and Implementing Policies,   62     Recent Changes in Health Care and Social Services,   63     Conclusions,   66 6   Implementation and Impact of the Public Health Service Counseling and Testing Guidelines   68     Development of the Public Health Service Counseling and Testing Guidelines,   69     Implementation of the Public Health Service Guidelines in Law, Regulation, and Policy,   69     Implementation of the Guidelines by Professional Organizations,   71     Implementation of Counseling and HIV Testing and Quality Care for HIV-Infected Pregnant Women,   73     Strategies to Reduce Perinatal HIV Transmission,   104     Conclusions,   106 7   Recommendations   109     Universal HIV Testing, with Patient Notification, as a Routine Component of Prenatal Care,   109     Incorporating Universal, Routine HIV Testing into Prenatal Care,   113     Resources and Infrastructure,   122     Other Approaches to Preventing Perinatal HIV Transmission,   126     Population Groups That May Face Additional Barriers,   131     Conclusions,   132     References   134     Appendixes         A Committee and Staff Biographies   147     B Context of Services for Women and Children Affected by HIV/AIDS   155     C Workshop I Summary   190     D Workshop II Summary   203     E New York/New Jersey Site Visit Summary   236     F Alabama Site Visit Summary   252     G South Texas Site Visit Summary   260     H Florida Conference Summary   271

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-->     I HIV Testing and Perinatal Transmission: Thoughts from an HIV-Positive Mother   275     J Human Immunodeficiency Virus Antibody Testing Among Women 15–44: Results from the 1995 National Survey of Family Growth   286     K Details of the Committee's Models and Assumptions   304     L Passing the Test: New York's Newborn HIV Testing Policy, 1987–1997   313     M Excerpts from the Ryan White CARE Act Amendments of 1996   341     N 1995 U.S. Public Health Service Recommendations for Human Immunodeficiency Virus Counseling and Testing for Pregnant Women   347     O Acronyms and Glossary   372     Index   377

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