HIV Screening of Pregnant Women and Newborns

Leslie M. Hardy, Editor

Committee on Prenatal and Newborn Screening for HIV Infection

Institute of Medicine


NATIONAL ACADEMY PRESS
Washington, D.C.
1991



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page R1
HIV Screening of Pregnant Women and Newborns HIV Screening of Pregnant Women and Newborns Leslie M. Hardy, Editor Committee on Prenatal and Newborn Screening for HIV Infection Institute of Medicine NATIONAL ACADEMY PRESS Washington, D.C. 1991

OCR for page R1
HIV Screening of Pregnant Women and Newborns NATIONAL ACADEMY PRESS 2101 Constitution Avenue, NW 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 competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. 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 both 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. Support for this project was provided by the National Institute of Child Health and Human Development (contract no. NO1-HD-9-2926) and the Centers for Disease Control. Library of Congress Catalog Card No. 90-63689 International Standard Book Number 0-309-04428-6 Additional copies of this report are available from: National Academy Press 2101 Constitution Avenue, N.W. Washington, D.C. 20418 S270 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 image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin. First Printing, January 1991 Second Printing, September 1991

OCR for page R1
HIV Screening of Pregnant Women and Newborns COMMITTEE ON PRENATAL AND NEWBORN SCREENING FOR HIV INFECTION MARIE C. McCORMICK (chair), Joint Program in Neonatology, Harvard Medical School, Boston, Massachusetts LORI B. ANDREWS, American Bar Foundation, Chicago, Illinois MOLLY J. COYE, Division of Public Health, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland ROBERT A. DERZON, Lewin/ICF, Inc., San Francisco, California NORMAN C. FOST, Department of Pediatrics, University of Wisconsin School of Medicine, Madison LAURENCE R. FOSTER, Office of Epidemiology and Health Statistics, Health Division, Oregon Department of Human Resources, Portland RODNEY HOFF (government liaison member), Epidemiology Branch, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland MICHAEL M. KABACK, Department of Pediatrics, University of California, San Diego BARBARA J. SABOL, Human Resources Administration, New York, New York A. EUGENE WASHINGTON, Center for Reproductive Health Policy Research, Department of Obstetrics, Gynecology, and Reproductive Sciences, and Institute for Health Policy Studies, School of Medicine, University of California, San Francisco STAFF LESLIE M. HARDY, Project Director GAIL GELLER, Consultant LEAH MAZADE, Staff Editor GAlL SPEARS, Administrative Assistant ROBIN WEISS, Director, AIDS Activities

OCR for page R1
HIV Screening of Pregnant Women and Newborns This page in the original is blank.

OCR for page R1
HIV Screening of Pregnant Women and Newborns PREFACE Policymakers face special challenges in formulating rational human immunodeficiency virus (HIV) testing and screening policies for women and children. Incomplete data and complex medical, social, and ethical questions confound the decision-making process. Moreover, decisions must be made and policies implemented in a continually changing environment as the epidemic of HIV infection and acquired immune deficiency syndrome (AIDS) evolves and the development and refinement of diagnostic technology and medical therapy proceed apace. In recent months policymakers have come to appreciate the extent and seriousness of the problem of HIV disease among women and children, and this perception has brought proposals for screening pregnant women and newborns for HIV. The prospect of HIV screening among these populations engenders spirited debate in many arenas. In particular, public policy discussions attempt to grapple with determining what constitutes an acceptable balance between the medical and public health benefits and the consequent personal and societal costs of such screening. In light of this ongoing debate (and the potential for damaging ad hoc recommendations), the National Institute of Child Health and Human Development and the Centers for Disease Control requested that the Institute of Medicine assemble an expert committee to offer direction to policymakers and to examine the myriad questions that frame the development of sound perinatal HIV screening policy. Specifically, the committee's charge was to assess the appropriateness, at this time, of screening pregnant women and newborns for HIV infection, to consider the criteria that should be satisfied when such screening is introduced, and to reflect on possible advances in treatment and HIV diagnostic capability (particularly for neonates) that might necessitate policy modifications. As part of its deliberations, the committee convened a public conference on May 14-15, 1990, to explore the salient technical, medical,

OCR for page R1
HIV Screening of Pregnant Women and Newborns legal, and ethical aspects of HIV screening proposals for pregnant women and newborns. Appendix A contains the program of the conference and a summary of its activities. Such a summary cannot, of course, fully capture the richness and breadth of the panelists' presentations and subsequent discussions, but it does provide a synthesis of the major issues raised and the concerns expressed during the conference. It also reflects the subjective views of the speakers, which do not necessarily coincide with the conclusions reached by the committee. These differences of opinion mirror the controversy inherent in perinatal HIV screening policy development and serve as a reminder that many policy decisions in this area are to some extent based on judgment. Indeed, the evolving nature of the HIV epidemic and current gaps in knowledge, as well as changing technology, often require that informed judgment supplement incomplete data. The conference greatly enriched the committee's deliberations, and committee members and staff extend their thanks both to the speakers, for their informative, provocative presentations, and to those who attended, for their constructive, lively contributions to the discussions. In particular, the committee acknowledges the thoughtful commentary of the final panelists: Neil Holtzman, Edward Connor, Sheldon Landesman, Kristine Gebbie, and Ronald Bayer. Their discussion of the considerations that should inform the development of prenatal and newborn HIV screening policy as well as their policy judgments helped to crystallize the committee's conclusions and recommendations. Because this final panel by design reiterated many of the themes that surfaced throughout the conference, a discrete synopsis of their discussion does not appear in the summary. This report presents the committee's collective judgment about whether screening pregnant women or newborns for HIV infection is currently appropriate and discusses the process by which screening policy should be developed and implemented. It is intended to offer direction to state policymakers faced with decisions about instituting publicly sponsored prenatal or newborn HIV screening programs and consequently focuses primarily on their design and implementation. All statements and recommendations within the report are specific to the United States. Nevertheless, the guidance provided in the committee's recommendations may also be applicable to other settings in which screening policy might be developed. Finally, the committee was continually reminded of the broader implications for other population groups (e.g., nonpregnant adolescents and adults) of its recommendations for HIV screening of pregnant women. The committee's charge did not include the examination of HIV screening policy for other individuals of reproductive age who might also benefit from the early diagnosis of infection and medical intervention. The

OCR for page R1
HIV Screening of Pregnant Women and Newborns committee believes, however, that the extension of HIV screening to these other populations should be carefully studied and evaluated. MARIE C McCORMICK Chair, Committee on Prenatal and Newborn Screening for HIV Infection LESLIE M. HARDY Project Director

OCR for page R1
HIV Screening of Pregnant Women and Newborns This page in the original is blank.

OCR for page R1
HIV Screening of Pregnant Women and Newborns CONTENTS     EXECUTIVE SUMMARY   1 1   INTRODUCTION   9 2   DESCRIBING THE EPIDEMIC OF HIV INFECTION AND AIDS AMONG WOMEN AND CHILDREN IN THE UNITED STATES   13     Epidemiology of HIV Infection and AIDS Among Women   13     Epidemiology of HIV Infection and AIDS Among Children   17 3   SCREENING FOR HIV INFECTION   19     Technical Characteristics of a Screening Test and the HIV Testing Algorithm   20     Format of a Screening Program   22 4   NEWBORN SCREENING FOR HIV INFECTION   25     Early Therapeutic Intervention for Asymptomatic HIV-Infected Children   25     Limitations in HIV Diagnostic Technology for Infants   26     Aggressive Medical Management of HIV-Seropositive Infants   27     Other Considerations for Newborn HIV Screening   28     Reevaluating Newborn HIV Screening Policy   29 5   PRENATAL SCREENING FOR HIV INFECTION   33     Effects on Vertical HIV Transmission   33     Effects on Horizontal HIV Transmission   34

OCR for page R1
HIV Screening of Pregnant Women and Newborns     Informed Reproductive Decision Making   35     Early Diagnosis of HIV Infection and Therapeutic Intervention During Pregnancy   35     Additional Benefits of Prenatal HIV Screening   38     Universal Versus Selective Prenatal HIV Screening   39 6   FORMULATING PRENATAL HIV SCREENING POLICY   43     Establishing an Epidemiological Basis for Prenatal Screening   43     Pilot Studies of New Screening Programs   45     Implementation of Prenatal HIV Screening Policy   46 7   ELEMENTS OF A PRENATAL HIV SCREENING PROGRAM   49     Education and Counseling   49     Partner Involvement   51     Confidentiality   51     Partner Notification   52     Services for HIV-Infected Women and Children   53     Health Care Provider Education and Training   55     Laboratory Services   56     Program Evaluation   57     REFERENCES   61     APPENDIXES     A.   The Conference: Program and Summary   69 B.   Cost and Probability Assumptions Used in Cost-Effectiveness Analysis of Prenatal HIV Screening   129 C.   Cost Estimates: Early Intervention for HIV Infection   135 D.   Committee Biographical Notes   143

OCR for page R1
HIV Screening of Pregnant Women and Newborns HIV SCREENING OF PREGNANT WOMEN AND NEWBORNS

OCR for page R1
HIV Screening of Pregnant Women and Newborns This page in the original is blank.