Introduction

The critical role of injection drug use in the spread of the human immunodeficiency virus (HIV) in this country is manifest. Early in the epidemic, it was implicated as a primary mode of transmission (Masur et al., 1981; Centers for Disease Control, 1982). The observed clustering of reported cases of acquired immune deficiency syndrome (AIDS) in specific populations (e.g., homosexual men, injection drug users, recipients of blood and blood products) was one of the original pieces of evidence that indicated the possibility that an infectious agent was the underlying cause of the disease (Friedland and Klein, 1987).

DIMENSIONS OF THE PROBLEM

Although no changes in the primary routes of transmission (sexual contact, injection drug use, blood/blood products, perinatal) have been observed over the years, the proportion of cases by exposure mode and the distribution of new cases across demographic characteristics (e.g., sex, ethnicity/race, geographic location) have changed drastically over the last 13 years. As we discuss in this report, the proportion of AIDS cases attributed to the exposure category labeled men who have sex with men by the Centers for Disease Control and Prevention (CDC) has declined steadily over the past 13 years (from 74 percent in 1981 to 47 percent in 1993), while the proportion of cases attributed to injection drug use has steadily increased during that period (from 12 percent in 1981 to 28 percent in 1993). The proportion



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Preventing HIV Transmission: The Role of Sterile Needles and Bleach Introduction The critical role of injection drug use in the spread of the human immunodeficiency virus (HIV) in this country is manifest. Early in the epidemic, it was implicated as a primary mode of transmission (Masur et al., 1981; Centers for Disease Control, 1982). The observed clustering of reported cases of acquired immune deficiency syndrome (AIDS) in specific populations (e.g., homosexual men, injection drug users, recipients of blood and blood products) was one of the original pieces of evidence that indicated the possibility that an infectious agent was the underlying cause of the disease (Friedland and Klein, 1987). DIMENSIONS OF THE PROBLEM Although no changes in the primary routes of transmission (sexual contact, injection drug use, blood/blood products, perinatal) have been observed over the years, the proportion of cases by exposure mode and the distribution of new cases across demographic characteristics (e.g., sex, ethnicity/race, geographic location) have changed drastically over the last 13 years. As we discuss in this report, the proportion of AIDS cases attributed to the exposure category labeled men who have sex with men by the Centers for Disease Control and Prevention (CDC) has declined steadily over the past 13 years (from 74 percent in 1981 to 47 percent in 1993), while the proportion of cases attributed to injection drug use has steadily increased during that period (from 12 percent in 1981 to 28 percent in 1993). The proportion

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach of heterosexual cases has also increased over the years (from 1 percent in 1981 to 9 percent in 1993), and women are disproportionately affected in this latter category (of all new AIDS cases reported in 1993, heterosexual contact accounted for 4 percent of AIDS cases among men and 37 percent among women). Injection drug use has been tied to the majority of AIDS cases among heterosexuals and is a major risk factor associated with pediatric cases. Furthermore, the rate of AIDS cases linked to injection drug use is disproportionately high for African Americans and Hispanics. Injection drug users represent a sizable population. Estimates of current injection drug users in the United States range from 1.1 to 1.9 million people (Turner et al., 1989; Office of Technology Assessment, 1990; Research Triangle Institute, 1989; Valdiserri et al., 1993), and more than 3.2 million people have injected drugs at some point in their lives (National Institute on Drug Abuse, 1991). There is of course substantial variation across the country in the number of injectors within specific geographic areas. For example, typically high rates of injection drug use are observed in the Northeast, Miami, and Puerto Rico; moderate rates in the West; and low rates in the Midwest. The experiences of several large urban areas have shown how infection among injection drug users can explode rapidly after the introduction of the virus into that population. For example, within two years the HIV prevalence1 rates in Edinburgh, Scotland, soared from 5 percent in 1983 to 57 percent in 1985 (Robertson et al., 1986); the rates in Bangkok, Thailand, increased from 1 to 43 percent in one year (Berkelman et al., 1989); and by 1985, seroprevalence estimate rates as high as 69 percent were reported in Milan, Italy (Titti et al., 1987; Angarano et al., 1985). Similarly in the United States, the virus spread rapidly in New York City in the early 1980s, with seroprevalence stabilizing at between 55 and 60 percent in 1984 through 1987 (Des Jarlais et al., 1989). The main factor associated with the accelerated increase in HIV infection among injection drug users is the widespread sharing of needles or syringes, which is in part a consequence of the restricted availability of sterile injection equipment. Moreover, it is a matter of concern that epidemiologic data indicate that, given the large number of injection drug users and their comparatively high incidence of HIV, the basic elements necessary for the rapid diffusion of the virus are apparent. That is, communities of injection drug users with high levels of both HIV infection and risk behaviors (i.e., involving drugs and sex) can serve as a bridge across distinct populations and efficiently impact the infection rate of other groups for which the HIV prevalence rates are currently relatively low. The epidemiologic data do indicate that the HIV epidemic in this country is now clearly driven by infections occurring in the population of injection drug users, their sexual partners, and their offspring.

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach RESPONSES TO THE EPIDEMIC The magnitude of the epidemic and the severity of the health consequences posed by HIV infection within the population of injection drug users, their sexual partners, and their offspring are not at issue. What is being strenuously debated in the United States is whether certain AIDS prevention programs, directed at this highly vulnerable population, should be implemented with the assistance of the federal government. Needle exchange programs, in which used needles are exchanged for new, sterile ones, are widely used in many industrialized countries (e.g., France, the Netherlands, Great Britain, Australia, Canada) as part of public health efforts to reduce the spread of HIV and other blood-borne infections among drug users, their sexual partners, and the general population. In the United States, although approximately 75 needle exchange programs have been initiated in 55 cities, many are small and the programs have not yet been endorsed by the federal government as a viable intervention for AIDS prevention. The debate in the U.S. Congress has been intense between members who are particularly interested in AIDS prevention initiatives and members who are concerned that the use of federal funds to implement needle exchange programs would have the unintended effect of increasing injection drug use in those communities already plagued by drug abuse. To date, the impasse between these two camps has blocked any use of federal funds for needle exchange program services. Indeed, the use of appropriated funds by the Department of Health and Human Services to support needle exchange programs has been specifically prohibited or restricted by the language contained in a series of statutes2 enacted by Congress since 1988. The U.S. General Accounting Office (1993) recently analyzed the legal authority applicable to the federal support of research and services related to needle exchange. It concluded, primarily on the basis of language contained in section 514 of the "General Provisions" of the 1993 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act, that, although the Department of Health and Human Services is restricted from using certain funds to support the funding of needle exchange programs directly, it does have the authority to conduct demonstration and research projects that involve the provision of needles. Nevertheless, the ban on federal support for needle exchange program services still remains in effect: "… unless the Surgeon General of the United States determines that such programs are effective in preventing the spread of HIV and do not encourage the use of illegal drugs" (U.S. Congress, 1992a). This current prohibition applies regardless of the legal standing of the programs operating in individual states. As a result, needle exchange programs across the country cannot use

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach federal funds to support services involving the provision of needles, but must rely on funding from state, municipal, and private sources. THE CHARGE TO THE PANEL This unresolved debate led Congress to request, through the ADAMHA Reorganization Act (U.S. Congress, 1992b) that the National Academy of Sciences undertake a study to determine the effectiveness of needle exchange and bleach distribution programs on the spread of HIV in order to allow the Surgeon General to determine whether federal funds can be used to carry out such programs (P.L. 102-394, Section 514). More specifically, the mandate called for the study to make determinations of the following: The extent to which the programs promote, directly or indirectly, the abuse of drugs through providing information or devices (or both) regarding the manner in which the adverse health consequences of such abuse can be minimized. In the case of individuals participating in the programs, the number of individuals who have engaged in the abuse of drugs prior to admission to the programs and the number of individuals who have not engaged in such abuse prior to such admission. The extent to which participation in the programs has altered any behaviors constituting a substantial risk of contracting acquired immune deficiency syndrome or hepatitis, or of transmitting either of the diseases. The number of programs that provide referrals for the treatment of such abuse and the number of programs that do not provide such referrals. The extent to which programs safely dispose of used hypodermic syringes and needles. In response to this request of Congress, the National Research Council/Institute of Medicine established the Panel on Needle Exchange and Bleach Distribution Programs and outlined its charge as follows: The panel will gather and analyze the relevant research regarding the effect of such programs on rates of drug use, the behavior of drug users, and the spread of AIDS and other diseases, such as hepatitis, among intravenous drug users and their partners. In addition, the panel will examine closely related issues of importance to the research and service communities, such as the characteristics associated with effective exchange programs, and will provide recommendations for future research directions and methods applicable to the evaluation of syringe exchange and bleach programs. In the latter task, the study will identify the relevant evaluation

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach hypotheses and delineate the most appropriate methodologies for testing such hypotheses. The panel is authorized, but not committed, to asses the potential risks and benefits associated with the implementation of such programs if it judges the data adequate to make such an assessment. The charge gives special attention to the first three of the five tasks specified in the congressional mandate. The panel addressed tasks 4 and 5 as specified in the mandate by relying primarily on the research findings of two large-scale studies, undertaken with support from the federal government, that devoted a substantial amount of attention to these issues (U.S. General Accounting Office, 1993; Lurie et al., 1993). The panel's charge refers to both needle exchange and bleach distribution programs, and a brief characterization of these programs will shed some light on the panel's scope of work. Diverse AIDS prevention programs have been implemented in attempts to reduce the spread of HIV among injection drug users, their sexual partners, and their offspring. These include, but are not limited to, educational, testing and counseling, needle exchange, and bleach distribution programs. A review of the services and devices delivered by needle exchange and bleach distribution programs (see Chapter 3) makes it clear that these programs do have many common elements and are not mutually exclusive. That is, the majority of the needle exchange programs distribute bleach, educational material, and condoms and make referrals to drug treatment and other services. Bleach programs typically dispense bleach, condoms, and educational materials and provide treatment and other referrals (e.g., primary care, public services). Both types of AIDS prevention programs attempt to prevent the transmission of the virus through the use of infected equipment and sexual risk behaviors. Both types of programs adopt multiple strategies in an attempt to reduce high-risk behaviors (e.g., injection and sexual behaviors). The primary distinguishing characteristic between them is that needle exchange programs provide as one of their main services the exchange of sterile needles for the return of used ones, whereas bleach distribution programs provide a readily available disinfectant (i.e., household bleach) to clean needles not meant to be reused. A recent public health bulletin (Centers for Disease Control and Prevention, 1993), which was issued jointly by the National Institute on Drug Abuse of the National Institutes of Health, the Center for Substance Abuse Treatment of the Substance Abuse and Mental Health Services Administration, and the Centers for Disease Control and Prevention, makes it clear that the use of bleach can play a role in reducing risk of HIV transmission, but it does not always sterilize the injection equipment. Specifically, the bulletin states that sterile, never-used needles and syringes are safer than bleach-disinfected,

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach previously used needles and syringes, which in turn are safer than used needles and syringes that have not been disinfected with bleach. The bulletin also emphasizes that those individuals who continue to inject drugs should be made aware of the limitations associated with using bleach and encouraged to always use sterile injection equipment and warned to never reuse or share needles, syringes, and other injection equipment. Given that disposable needles and syringes are not intended for reuse (their design does not easily allow for efficient disinfection), some have argued that preventive interventions should have as a goal to get every injection drug user to comply with the same standards that are upheld for patient care by the health care delivery system and the medical profession—that is, a new needle and syringe for every injection (Jones, 1994). THE PANEL'S REPORT Information Sources To carry out its charge, the panel undertook a variety of approaches to collect and analyze research data and other pertinent information. In addition to literature searches, panel assessments of evaluation studies, and briefings by technical experts at the panel's scheduled meetings, two informational workshops were convened. The first was designed to examine the impact of needle exchange and bleach distribution programs on drug-use behavior and the spread of HIV infection. The primary purpose of the workshop was to assist the panel in gathering and analyzing the relevant research regarding the effect of needle exchange and bleach distribution programs on rates of drug use, the behavior of drug users, and the spread of AIDS and other diseases, such as hepatitis, among intravenous drug users and their partners. A number of speakers, discussants, and participants were invited on the basis of their demonstrated expertise in the relevant research areas (National Research Council/Institute of Medicine, 1994). The second workshop brought together community leaders to present their communities' views on and reactions to needle exchange and bleach distribution programs. The intent was to provide panel members with this important input to consider in their deliberations and to encourage a useful discussion of the issues involved in program implementation and the delivery of prevention services. Approach This report examines a wide range of studies concerning the magnitude and severity of injection drug use, HIV infection among injection drug users and their partners, the effects of needle exchange and bleach distribution

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach programs on drug use, HIV risk behaviors, and the spread of HIV/AIDS. These include epidemiologic studies of injection drug use and HIV/AIDS, laboratory experiments and field studies on the efficacy and effectiveness of bleach in decontaminating injection equipment, and ethnographic accounts as well as empirical evaluations of needle exchange and bleach distribution programs. The studies that examine needle exchange and bleach distribution programs have a variety of limitations, including inadequate samples, sample attrition, improper controls, problematic measures, and incomplete analyses. Nevertheless, the limitations of individual studies do not necessarily preclude us from being able to reach scientifically valid conclusions based on the body of literature available on the issues of interest. The strategy adopted by the panel in reviewing the literature on this topic was to first distinguish between high-quality and lesser-quality studies and to weigh the credibility of the findings according to their completeness and soundness. Using this approach, the panel bases its conclusions on the pattern of evidence provided by a set of high-quality studies, rather than relying on the preponderance of evidence across less scientifically sound studies (see Chapter 7). Furthermore, the panel examined whether the results of a number of less rigorous studies conformed with the results of the most rigorous studies. In some areas, however, this was not possible, and consequently the panel's efforts to answer certain questions were hampered by the lack of research. Acknowledging the methodological limitations of certain individual studies, the panel also recognizes that most of them have been subject to a number of the mechanisms used by the scientific community to ensure the scientific adequacy of research—including the peer review process used in scientific and professional journals, scientific advisory panels and review groups, and external reviews of research—prior to their execution and/or publication. The majority of the studies reviewed in this report have satisfied these scientific criteria. Nonetheless, as is the case with many socially controversial programs (such as those involving sexual behavioral research, teenage pregnancy, contraception), the research findings we discuss have been the topic of heated debates among health policy decision makers who support or oppose such programs (Hartsock, 1993; Des Jarlais and Friedman, 1993; Office of National Drug Control Policy, 1992; Ginzburg, 1993; Kaplan, 1993). After examining the relevant research, one important conclusion the panel reached is that the body of evidence is sufficient to allow informed scientific judgments to be formulated about the impact of these programs on issues of public health. A point worth noting here is that, amidst the controversy, there are some issues on which both proponents and opponents seem to agree. Although the debate is heated, individuals on both sides of the issue would

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach concur that treatment is an efficient approach to dealing with injection drug use. Ultimately, both proponents and opponents would agree that, in dealing with current injection drug users, complete cessation of injection drug use would eliminate needles and syringes as a major route of transmission. Consequently, enrolling injection drug users in drug abuse treatment programs is viewed by both opponents and proponents as a highly desirable goal for countering the spread of HIV. The controversy emerges when attempting to determine the best strategy for achieving such a goal. Organization This report is organized into two parts. Part 1: Dimensions of the Problem begins with a summary of current information about the epidemiology of HIV/AIDS in Chapter 1. It is followed by the presentation of data on the epidemiology of injection drug use in Chapter 2. Chapter 3 describes the characteristics of needle exchange and bleach distribution programs, highlighting the many variations in organizational structure, context, and services, as well as the dynamic nature of the programs. Chapter 4 summarizes the views of various communities on needle exchange programs. We discuss input from diverse communities, including law enforcement, health professionals, and ethnic groups. In this chapter, the panel briefly addresses moral and ethical issues as they relate to the implementation of needle exchange and bleach distribution programs and their potential adverse effect on illicit drug use. The panel discusses concerns that arise as a consequence of implementing prevention programs that attempt to contain the propagation of a deadly disease linked to illicit drug-use behavior with a focus toward the preservation of human life. However, the panel elected not to elaborate on whether the illicit use of drugs is in itself moral or ethical. Part 2: Impact of Needle Exchange and Bleach Distribution Programs addresses the critical issues concerning the impact of needle exchange and bleach distribution programs. Chapter 5 examines the impact of paraphernalia and prescription laws on sharing behavior and HIV transmission. Chapter 6 reviews laboratory research on the efficacy of bleach as a disinfectant, and the limitations associated with that research literature are highlighted. This chapter also summarizes field studies that have assessed how effectively injection drug users in real-life settings comply with current recommended standards of bleach disinfection. Finally, this chapter summarizes the findings of evaluation studies that have assessed the impact of bleach distribution programs. Chapter 7 addresses the effectiveness of needle exchange programs in preventing the transmission of HIV and other diseases, as well as the impact of these HIV/AIDS prevention programs on drug-use behaviors. We note

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach that the conclusions and recommendations in this chapter are based not only on the findings presented in this chapter, but also on the findings and conclusions presented in the earlier chapters. This presentation reflects the cumulative development of the panel's understanding about the issues inherent in the establishment of needle exchange and bleach distribution programs and, ultimately, their anticipated effects, based on the pattern of evidence the panel discerned from its collection of descriptive and analytic materials, community views, and reviews of pertinent studies. Chapter 8 identifies issues that need to be studied further. The report includes three appendixes. Appendix A is a detailed description and review of some unpublished research findings, which came to the panel's attention as we were completing our review of the available evidence on needle exchange and bleach distribution programs (see the Preface). These studies are significant because their results appear to conflict with the findings of the body of literature reviewed in this report and have the potential of being misinterpreted. Appendix B presents a detailed summary of the views of various professional associations on needle exchange and bleach distribution programs. Appendix C gives biographical information about panel members and the study director. NOTES 1.   Prevalence denotes the proportion of a population that is currently (or at a specified point in time) infected. Incidence denotes the rate of occurrence of new cases of infection per unit of time. 2.   These statutes include the Comprehensive Alcohol Abuse, Drug Abuse, and Mental Health Amendments Act of 1988, the Health Omnibus Programs Extension of 1988, the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, and the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Acts of 1990 and 1991. REFERENCES Angarano, G., G. Pastore, L. Monno, T. Santantonio, N. Luchena, and O. Schiraldi 1985 Rapid spread of HTLV-III infection among drug addicts in Italy. Lancet 2(8467):1302. Berkelman, R.L., W.L. Heyward, J.K. Stehr-Green, and J.W. Curran 1989 Epidemiology of human immunodeficiency virus infection and acquired immunodeficiency syndrome. American Journal of Medicine 86:761-770. Centers for Disease Control 1982 Pneumocystis pneumonia. Morbidity and Mortality Weekly Report 30:250-252. Centers for Disease Control and Prevention, Centers for Substance Abuse Treatment, National Institute on Drug Abuse 1993 HIV/AIDS Prevention Bulletin April 19. Des Jarlais, D.C., S.R. Friedman, D. Novick, J.L. Sotheran, P. Thomas, et al. 1989 HIV-1 infection among intravenous drug users in Manhattan, from 1977 through 1987. Journal of the American Medical Association 261:1008-1012.

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach Des Jarlais, D.C., and S.R. Friedman 1993 Missing the point: Science and politics in the American debate on syringe exchanges. Pediatric AIDS and HIV Infection: Fetus to Adolescent 4(2):61-65. Friedland, G.H., and R.S. Klein 1987 Transmission of the human immunodeficiency virus. New England Journal of Medicine 347(18):1125-1135. Ginzburg, H.M. 1993 Federal response to needle-exchange programs: Part II: A. Science vs. politics. Pediatric AIDS and HIV Infection: Fetus to Adolescent 4(2):88-91. Hartsock, P.I. 1993 National Institute on Drug Abuse (NIDA) needle exchange research: Maintaining rigorous science . Pp. 414-420 in Epidemiologic Trends in Drug Abuse, Volume II: Proceedings. Rockville, MD: National Institute on Drug Abuse. Jones, T.S. 1994 Update on Upcoming Research Activities Pertaining to Needle Exchange and Bleach Distribution. Presentation at the September meeting of the Panel on Needle Exchange and Bleach Distribution Programs, Woods Hole, MA. Kaplan, E.H. 1993 Federal response to needle-exchange programs: Part II: B. Needle-exchange research: The New Haven experience. Pediatric AIDS and HIV Infection: Fetus to Adolescent 4(2):92-96. Lurie, P., A.L. Reingold, B. Bowser, D. Chen, J. Foley, J. Guydish, J.G. Kahn, S. Lane, and J. Sorensen 1993 The Public Health Impact of Needle Exchange Programs in the United States and Abroad, Volume 1. San Francisco: University of California. Masur, H., M. Michelis, J. Greene, et al. 1981 An outbreak of community-acquired Pneumocystis carinii pneumonia: Initial manifestation of cellular immune dysfunction. New England Journal of Medicine 305(24):1431-1438. National Institute on Drug Abuse 1991 National Household Survey on Drug Abuse: Population Estimates 1991. Rockville, MD: National Institute on Drug Abuse. National Research Council/Institute of Medicine 1994 Proceedings, Workshop on Needle Exchange and Bleach Distribution Programs. Panel on Needle Exchange and Bleach Distribution Programs. Washington, DC: National Academy Press. Office of National Drug Control Policy 1992 Needle exchange programs: Are they effective? ONDCP Bulletin No. 7. Washington, DC: Executive Office of the President. Office of Technology Assessment 1990 The Effectiveness of Drug Abuse Treatment: Implications for Controlling AIDS/HIV Infection. (Report Number 052-003-0120-3). Washington, DC: U.S. Government Printing Office. Research Triangle Institute 1989 Estimation of the Size of Population Groups at Increased Risk of HIV Infection and AIDS in the United States (derived from pre-existing data). Research Triangle Institute, Research Triangle Park, NC. Robertson, J.R., A.B.V. Bucknall, P.D. Welsby, J.J. Roberts, J.M. Inglis, J.F. Peutherer, and R.P. Brettle 1986 Epidemic of AIDS-related virus (HTLV-III/LAV) infection among intravenous drug users. British Medical Journal 292(6519):527-529.

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Preventing HIV Transmission: The Role of Sterile Needles and Bleach Titti, F., A. Lazzarin, P. Costigliola, C. Oliva, L. Nicoletti, C. Negri, E. Ricchi, G. Donati, C. Uberti-Foppa, M.C. Re, et al. 1987 Human immunodeficiency virus (HIV) seropositivity in intravenous (i.v.) drug abusers in three cities of Italy: Possible natural history of HIV infection in i.v. drug addicts in Italy . Journal of Medicine and Virology 23(3):241-248. Turner, C.F., H.G. Miller, and L.E. Moses, eds. 1989 AIDS, Sexual Behavior, and Intravenous Drug Use. Committee on AIDS Research and the Behavioral, Social, and Statistical Sciences. Washington, DC: National Academy Press. U.S. Congress 1992a Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993, October 6. Public Law 102-394, 106 Stat. 1827, Section 514. 1992b ADAMHA Reorganization Act, July 10. Public Law 102-321, 106 Stat. 439, Section 706. U.S. General Accounting Office 1993 Needle Exchange Programs: Research Suggests Promise as an AIDS Prevention Strategy. Report Number GAO/HRD-93-60. Washington, DC: U.S. Government Printing Office. Valdiserri, R.O., T.S. Jones, G.R. West, C.H. Campbell, and P.I. Thompson 1993 Where injecting drug users receive HIV counseling and testing. Public Health Reports 108:294-298.

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