Preventing HIV Transmission

The Role of Sterile Needles and Bleach

Jacques Normand, David Vlahov, and Lincoln E. Moses, editors

Panel on Needle Exchange and Bleach Distribution Programs

Commission on Behavioral and Social Sciences and Education

National Research Council and

Institute of Medicine

NATIONAL ACADEMY PRESS
Washington, D.C.
1995



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Preventing HIV Transmission: The Role of Sterile Needles and Bleach Preventing HIV Transmission The Role of Sterile Needles and Bleach Jacques Normand, David Vlahov, and Lincoln E. Moses, editors Panel on Needle Exchange and Bleach Distribution Programs Commission on Behavioral and Social Sciences and Education National Research Council and Institute of Medicine NATIONAL ACADEMY PRESS Washington, D.C. 1995

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W. Washington, D.C. 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. 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. This project was sponsored by the National Institute on Drug Abuse. Library of Congress Cataloging-in-Publication Data Preventing HIV transmission : the role of sterile needles and bleach / Jacques Normand, David Vlahov, and Lincoln E. Moses, editors. p. cm. “Panel on Needle Exchange and Bleach Distribution Programs, Commission on Behavioral and Social Sciences and Education, National Research Council and Institute of Medicine.” ISBN 0-309-05296-3 1. Needle exchange programs—United States. 2. Chlorine and derivatives as disinfectants. 3. AIDS (Disease)—United States—Prevention. I. Vlahov, David. II. Moses, Lincoln E. III. National Research Council (U.S.). Panel on Needle Exchange and Bleach Distribution Programs. IV. Institute of Medicine (U.S.) [DNLM: 1. HIV Infections—prevention & control. 2. Needle-Exchange Programs. 3. Disinfectants—supply & distribution. 4. Substance Abuse, Intravenous—complications. 5. Health Policy—United States. WC 503.6 P944 1995] RA644.A25P754 1995 616.97'9205—dc20 DNLM/DLC for Library of Congress 95-35458 CIP Printed in the United States of America Copyright 1995 by the National Academy of Sciences. All rights reserved.

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach PANEL ON NEEDLE EXCHANGE AND BLEACH DISTRIBUTION PROGRAMS LINCOLN E. MOSES (Chair), Department of Health Research and Policy, Division of Biostatistics, Stanford University RONALD S. BROOKMEYER, Department of Biostatistics, School of Hygiene and Public Health, The Johns Hopkins University LAWRENCE S. BROWN, JR., Division of Endocrinology, Department of Medicine, Harlem Hospital and College of Physicians and Surgeons, Columbia University and Division of Medical Services Evaluation and Research, Addiction Research and Treatment Corporation, Brooklyn RICHARD F. CATALANO, JR., Social Development Research Group, School of Social Work, University of Washington, Seattle DAVID S. CORDRAY, Center for the Study of At-Risk Populations and Public Assistance Policy, Vanderbilt Institute for Public Policy Studies and Department of Human Resources, Peabody College, Vanderbilt University DON C. DES JARLAIS, Chemical Dependency Institute, Beth Israel Medical Center and National Development and Research Institutes, Inc., New York CASWELL A. EVANS, JR., Public Health Programs and Services, County of Los Angeles Department of Health Services MARK B. FEINBERG, Department of Medicine and Microbiology and Immunology, University of California, San Francisco and Gladstone Institute of Virology and Immunology HERBERT D. KLEBER, Department of Psychiatry, Division on Substance Abuse, College of Physicians and Surgeons, Columbia University and New York State Psychiatric Institute and Center on Addiction and Substance Abuse, Columbia University PATRICK M. O'MALLEY, Institute for Social Research, University of Michigan, Ann Arbor NANCY S. PADIAN, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco MARIAN GRAY SECUNDY, Program in Medical Ethics, Department of Community Health and Family Practice, College of Medicine, Howard University DAVID VLAHOV, School of Hygiene and Public Health, The Johns Hopkins University

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach W. WAYNE WIEBEL, AIDS Outreach Intervention Project and School of Public Health, Epidemiology and Biostatistics, University of Illinois at Chicago DAVID R. WILLIAMS, Department of Sociology and Institute for Social Research, University of Michigan, Ann Arbor ALEXANDRA K. WIGDOR, Division Director JACQUES NORMAND, Study Director SUSAN R. McCUTCHEN, Senior Project Assistant

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach Contents     PREFACE   xi     ACKNOWLEDGMENTS   xv     EXECUTIVE SUMMARY   1     The Problem   1     The Panel's Charge   3     Scientific Assessment of Program Effectiveness   3     Community and Legal Factors   5     Recommended Course of Action   6     INTRODUCTION   9     Dimensions of the Problem   9     Responses to the Epidemic   11     The Charge to the Panel   12     The Panel's Report   14 PART 1   DIMENSIONS OF THE PROBLEM         1 THE EPIDEMIOLOGY OF HIV AND AIDS   23     Biological Mechanisms of Transmission   24     Injection Drug Use Transmission   24

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach     Sexual Transmission   28     Perinatal Transmission   29     Conclusion   30     Epidemiologic Data   31     HIV and AIDS Surveillance   31     Mode of Acquisition of Infection   32     HIV and AIDS Among Injection Drug Users   37     Surveillance   37     Sexual Transmission Among Injection Drug Users   40     Perinatal Transmission from Injection Drug Users   43     Summary   44     Conclusions   45     Recommendations   45     2 THE EPIDEMIOLOGY OF INJECTION DRUG USE   57     Estimates of Injection Drug Users   58     Geographic Variations   59     National Surveys of Drug Abuse   60     Characteristics of Injection Drug Users   64     A National Profile   64     Local Drug Use Trends and Patterns   66     Summary   69     Recommendation   69     3 NEEDLE EXCHANGE AND BLEACH DISTRIBUTION PROGRAMS IN THE UNITED STATES   74     Introduction   74     Needle Exchange Programs   75     Legal Issues   75     Program Operations   77     Characteristics of Program Participants   83     Cost and Cost-Effectiveness   86     Organizational Characteristics   89     Comparisons Across Programs   93     Bleach Distribution Programs   95     Characteristics of Program Participants   96     Outreach Strategies   97     Conclusion   99     4 COMMUNITY VIEWS   103     Moral/Ethical Arguments   105     Public Opinion Polls   106     African American Views   107

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach     Latino/Hispanic Views   120     Law Enforcement Views   121     Health Professional Views   123     Pharmacists   123     Treatment Service Providers   126     Summary   133     Conclusions   133     5 THE LEGAL ENVIRONMENT   143     U.S. Drug Control Policy   143     Legislative/Statutory Environment   145     Judicial Rulings   147     Do Paraphernalia and Prescription Laws Contribute to HIV Transmission?   149     Needle Scarcity and Sharing   150     Changes in the Laws in Connecticut   152     Should the Laws Be Changed?   155     Changing the Laws   156     Consequences   157     Conclusions   158     Recommendations   158 PART 2   THE IMPACT OF NEEDLE EXCHANGE AND BLEACH DISTRIBUTION PROGRAMS         6 THE EFFECTIVENESS OF BLEACH AS A DISINFECTANT OF INJECTION DRUG EQUIPMENT   167     Transmission of HIV Among Injection Drug Users   168     Bleach as a Disinfectant   169     Definition of Terms   169     The Role of Cleaning in Disinfection   170     Susceptibility of HIV to Disinfection   172     Bleach Distribution Programs   175     Program Evaluation   177     The Chicago Experience   180     Limitations of Bleach Disinfection   186     Impact of Bleach Disinfection on HIV Transmission   187     Summary   190     Conclusions   191     Recommendations   192

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach     7 THE EFFECTS OF NEEDLE EXCHANGE PROGRAMS   198     Potential Outcomes   199     Possible Positive Outcomes   199     Possible Negative Outcomes   199     The Panel's Approach to the Evidence   200     The Traditional Approach: Considering the Preponderance of the Evidence   200     An Alternative Approach: Looking at the Patterns of Evidence   201     The Panel's Synthesis   204     U.S. General Accounting Office Review   205     Procedure   205     Results   206     University of California Report   208     Procedure   208     Results   210     Possible Positive Outcomes   211     Possible Negative Outcomes   214     Summary   216     Evidence from Recent Studies   217     Possible Positive Outcomes   217     Possible Negative Outcomes   224     The New Haven Studies   226     Program Implementation   228     Estimated Effects on HIV Incidence   229     Assessment of the Models   230     New Initiates to Injection Drug Use   231     Enrollment in Drug Treatment   232     Alternative Explanations   232     Summary   233     The Tacoma Studies   234     The Program   235     HIV Seroprevalence Studies   240     Hepatitis Surveillance and Case Reporting   240     Hepatitis B and C Case-Control Study   242     Interview Studies with Injection Drug Users   243     Potential Alternative Explanations   244     Program Effects on New Initiates to Drug Use or Abuse   248     Summary   250     Conclusions   251     Recommendations   252     8 DIRECTIONS FOR FUTURE RESEARCH   263     Research on Program Effectiveness   264

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach     Needle Exchange Evaluation   264     Program Characteristics   267     Research on Bleach Efficacy in Disinfection   270     Epidemiologic Research   270     Research on Community Issues   272     Other Future Research Issues   273     Deregulation of Syringe Sale and Possession   273     Incarcerated Populations   274     Randomized Trial of Needle Exchange Programs   274     Broader Issues   275     Conclusion   276     APPENDIXES         A DESCRIPTION AND REVIEW OF RESEARCH PROJECTS IN THREE CITIES   281     San Francisco   281     Review   283     Montréal   285     Needle Exchange Evaluation Project   285     Epidemiologic Study   289     Chicago   293     Demand for Free Needles and Their Effect on Injecting Frequency and Needle Use   293     Effects of Exchange Use on HIV Risk Behavior and Incidence   302     Conclusion   304     B PROFESSIONAL ASSOCIATION POSITIONS ON NEEDLE EXCHANGE AND BLEACH DISTRIBUTION PROGRAMS   307     C BIOGRAPHICAL SKETCHES   313     INDEX   321

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievement of engineers. Dr. Harold Liebowitz is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Harold Liebowitz are chairman and vice chairman, respectively, of the National Research Council.

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach Preface The July 1992 ADAMHA Reorganization Act mandated that the Secretary of Health and Human Services, acting through the Director of the National Institute on Drug Abuse, request the National Academy of Sciences to conduct a study on the impact of needle exchange and bleach distribution programs on drug use behavior and the spread of the human immunodeficiency virus (HIV). In response to that legislative directive, in May 1993 the National Research Council (NRC) and the Institute of Medicine (IOM) of the National Academy of Sciences organized the Panel on Needle Exchange and Bleach Distribution Programs within the Commission on Behavioral and Social Sciences and Education. The panel's overall charge was to determine the effectiveness of needle exchange and bleach distribution programs. More specifically, the panel was asked to gather and analyze the relevant research regarding the effect of such programs on rates of drug use, the behavior of injection drug users, and the spread of AIDS and other diseases, such as hepatitis, among injection drug users and their sexual partners. In addition, the panel was asked to examine related issues of importance to the research and service communities, such as the characteristics associated with effective exchange programs, and to provide recommendations for future research directions and methods applicable to the evaluation of needle exchange and bleach programs. In the latter task, the panel was asked to identify the relevant evaluation hypotheses and delineate the most appropriate methodologies for testing such hypotheses. The panel was authorized, but not committed, to assess the potential risks and benefits associated with the implementation of

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach such programs if it judged the data adequate to make such an assessment. The panel first met in June 1993 and over two years worked to come to grips with the range of conceptual, methodological, and ideological issues associated with these controversial AIDS prevention programs. From the outset we recognized the importance, whenever there is a proposal to institute, cancel, or substantially modify a public health policy, of taking both ethical and empirical concerns into account. The wisdom of a public policy depends not only on its consistency with social consensus, but also on pragmatic consequences. With this base, the panel attempted to distill the essence of the ongoing and sometimes acrimonious debate on whether the federal government should provide financial assistance for implementing needle exchange and bleach distribution programs. Prohibitions, even those that are legally sound and represent well-intentioned efforts to limit the purchase or possession of equipment used to inject drugs, may be found to be ethically problematic. Furthermore, they may not be wise or proper when empirical judgments are warranted to accurately assess the effect of prevention programs on public health. The degree to which institutionalized needle exchange programs are considered ethical is based on measuring to whom they may be offensive and to what degree, whether drug abusers are encouraged to enter drug treatment programs, whether systematic harm is suffered by people of a particular social status, and whether a meaningful impact on reducing HIV transmission is made. It became apparent early in our work that several concerned constituencies held strong and varied views about the soundness of integrating these types of health promotion and disease prevention programs as part of the nation's public health efforts to reduce the spread of HIV infection. Hence, we proceeded to educate ourselves as fully as possible and carefully consider the broad range of views involved. The panel held several meetings and two workshops to which representatives of various community groups and researchers were asked to present their views on key issues. In its effort to gather and analyze the relevant scientific evidence, the panel invited both U.S. and foreign experts to participate in a two-day workshop (September 1993) devoted to the presentation and discussion of recent research on and experience with needle exchange and bleach distribution programs. A second workshop (January 1994) was designed to elicit the views of representatives of many of the communities with a stake in the outcome of the needle exchange and bleach distribution debate who have been actively engaged in the ongoing discussions. As the panel was concluding its deliberations, the Assistant Secretary for Health made public statements that a number of unpublished needle exchange evaluation reports had raised doubts in his mind about the effectiveness of these programs. The panel deemed these statements to be significant

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach in the public debate, therefore necessitating appropriate consideration in order for the panel to be fully responsive to its charge. We therefore reviewed the unpublished studies—by investigators in Chicago, Montréal, and San Francisco—that had raised concerns. As unpublished findings, these studies, though clearly salient, lack the authority provided by the peer review and publication process. For this reason, in the report we give special attention (in an appendix) to scrutinizing and describing in detail their results, as well as appraising their probative value. This report is the collective product of a panel whose members represent a balance in both expertise and points of view. Its contents reflect the careful deliberations and final consensus of the members. The panel is particularly indebted to two members, David Cordray and Don Des Jarlais, whose contributions of time, energy, and expertise to the crafting of the report were indeed extraordinary. The committee also benefited from the quality and dedication of the NRC and IOM staff. These included Eugenia Grohman, Michael Stoto, and Alexandra Wigdor, who provided constructive advice and guidance throughout the project. Christine McShane contributed significantly to the presentation of the panel's views through both substantive and technical editorial work. Her contributions to the language and structure of the report go far beyond what her title of editor might imply. Special thanks are due to Susan McCutchen, who coordinated all of our meetings, planned the workshop sessions, updated successive drafts of the report and prepared it for production, kept track of the work flow, and generally kept our work team organized. Her commitment and support at every stage of the panel's work was indispensible to the project. We are appreciative of and grateful for the efforts of these talented people. Lincoln E. Moses, Chair Jacques Normand, Study Director David Vlahov, Member Panel on Needle Exchange and Bleach Distribution Programs

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach Acknowledgments During the course of this study, the panel and staff have been assisted by many researchers and other individuals working in the field who took time to share their insights and expertise. Without this generous assistance, the panel would not have been able to complete its task. At the panel's September 1993 workshop in Baltimore, Maryland, a number of people made presentations on current research in needle exchange and bleach distribution: Benjamin Bowser (California State University), Alice Gleghorn (The Johns Hopkins University), Lawrence Gostin (Georgetown University), Samuel Groseclose (Centers for Disease Control and Prevention), Holly Hagan (Seattle-King County Health Department), Catherine Hankins (Montréal General Hospital), Noreen Harris (Seattle-King County Department of Public Health [deceased]), James G. Kahn (University of California at San Francisco), Edward Kaplan (Yale School of Management), Peter Lurie (University of California at San Francisco), Linda Martin (Centers for Disease Control and Prevention), Rose Martinez (U.S. General Accounting Office), Clyde McCoy (University of Miami), Margaret Millson (University of Toronto), Sheigla Murphy (Institute for Scientific Analysis), Ted Myers (University of Toronto), Kathy Oliver (Outside In, Portland), Denise Paone (Beth Israel Medical Center), Paul Shapshak (University of Miami), Linda Valleroy (Centers for Disease Control and Prevention), Anneke van den Hoek (Municipal Health Service Amsterdam), John Watters (University of California at San Francisco), and Alex Wodak (St. Vincent's Hospital, Darlinghurst, New South Wales). Robert Booth (University of Colorado), T. Stephen Jones (Centers for Disease Control and Prevention),

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach Andrew Moss (University of California), Lane Porter (consultant), and Peter Selwyn (Yale University) served as discussants. At an informal workshop held in January 1994, briefings on relevant community issues were provided by Russell Coon (National Association of Chain Drug Stores [affiliation American Drug Stores]), George Doane (law enforcement community [affiliation Bureau of Narcotic Enforcement]), Sairus Faruque (Latino community [affiliation Association for Drug Abuse Prevention and Treatment]), Gilbert Gallegos (law enforcement community [affiliation Fraternal Order of Police]), Wilbert Jordan (African American community [affiliation Los Angeles County AIDS Program]), Cleo Malone (African American community, California Coalition of Clergy and Congress of National Black Churches [affiliation Palavra Tree]), Suzi Rodriguez (Chicano/Mexican community [affiliation Los Angeles County Substance Abuse Task Force]), and Rose Sparks (American Pharmaceutical Association [affiliation South Coast Medical Center]). Many people assisted the panel in its deliberations by providing commissioned papers and/or data in specific research areas: Philip Alcabes (Yale University), Michael Aldrich (California AIDS Intervention Training Center), Walter Bond (Centers for Disease Control and Prevention), Barry Brown (University of North Carolina at Wilmington), Julie Bruneau (Hôpital St.-Luc, Montréal), Mary Ann Chiasson (New York City Department of Health), Richard Clayton (University of Kentucky), Sandra Crouse Quinn (Westat, Inc.), Dominick DePhilippis (University of Pennsylvania), Meg Doherty (The Johns Hopkins University), Martin Favero (Centers for Disease Control and Prevention), Blanche Frank (New York State Office of Alcoholism and Substance Abuse Services), Samuel Friedman (National Development and Research Institutes), Joseph Gfroerer (Substance Abuse and Mental Health Services Administration), Alice Gleghorn (The Johns Hopkins University), Janet Greenblatt (Substance Abuse and Mental Health Services Administration), Holly Hagan (Seattle-King County Health Department), Diana Hartel (Montefiore Medical Center), T. Stephen Jones (Centers for Disease Control and Prevention), Benny Jose (National Development and Research Institutes), Mark Kleiman (Harvard University), Thomas Lampinen (University of Washington), Carl Leukefeld (University of Kentucky), Jerry Mandel (La Familia Unida AIDS Outreach Project), Linda Martin (Centers for Disease Control and Prevention), David Metzger (University of Pennsylvania), Lynne Mofenson (National Institutes of Health), James Murray (University of Illinois at Chicago), John Newmeyer (Haight Ashbury Free Medical Clinics), Mary Utne O'Brien (University of Illinois at Chicago), Lawrence Ouellet (University of Illinois at Chicago), Denise Paone (Beth Israel Medical Center), Jenny Rudolph (BOTEC Analysis Corporation), Peter Selwyn (Yale University), Stephen Thomas (Emory University), Thomas Ward (National Development and Research Institutes), and Norman Williams

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach (New York State Office of Alcoholism and Substance Abuse Services). In addition, researchers Antonio Jimenez, Wendell Johnson, and Afsaneh Rahimian, together with outreach workers Hermando Lira, Ed Mulligan, and Larry Smith, are some of the many intervention staff at field stations in Chicago, Illinois, who provided the panel with invaluable insight into working with drug users and abusers on the street. The panel and staff would like to acknowledge project staff of the National Institute on Drug Abuse, the project's sponsoring agency, for their assistance in making our work run smoothly. Our project officers were especially helpful: Peter Hartsock provided guidance and technical support throughout the project; Sander Genser offered guidance, particularly in the early stages of the panel's deliberations; Richard Needle served as a project officer as well; and Carol Cushing provided advice and assisted in the administration of the contract. T. Stephen Jones, of the Centers for Disease Control and Prevention, assisted the panel through briefings and providing data during the course of the study. Ripley Forbes, of the House Subcommittee on Health and Environment, briefed the panel in the early stages of its deliberations and helped members focus on the task at hand from the legislative perspective. The panel extends its sincere thanks and appreciation to all those who have assisted us in our work. Lincoln E. Moses, Chair Jacques Normand, Study Director David Vlahov, Member Panel on Needle Exchange and Bleach Distribution Programs

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