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3 Sterile Needle and Syringe Access, and Outreach and Education For those who are unable to stop using or injecting drugs, sterile needle and syringe access aims to reduce HIV transmission by increasing access to sterile injecting equipment, removing contaminated needles from circulation, and preventing needles and syringes from being discarded in the community, where others might reuse them or suffer needle sticks. Access can be ensured through needle and syringe exchange, pharmacy and prescription-based sales, vending machines, supervised injecting facilities, and disinfection programs. Many sterile needle and syringe access programs also encourage the cessation of drug abuse through referrals to drug treatment, and the reduction of sex-related risk through the provision of condoms. All these interventions can be combined with outreach and education. This chapter starts with a discussion of needle and syringe exchange (NSE).1 In many regions of the world where it has been implemented and evaluated, needle and syringe exchange is usually part of a multi-component HIV prevention effort. To properly reflect this, the Committee refers to such programs as multi-component HIV prevention programs 1 Needle and syringe exchange refers broadly to supplying clean needles and syringes to IDUs and collecting used injecting equipment. While some programs require exchange of used needles for clean ones, need-based programs allow unlimited distribution of needles and syringes.
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that include needle and syringe exchange. These are defined as interventions that combine needle and syringe exchange with any one or more of the following services: outreach, health education in risk reduction, condom distribution, bleach distribution coupled with education on needle disinfection, and referrals to substance abuse treatment and other health and social services. In this report, the term multi-component HIV prevention programs does not include drug dependence treatment and other medical or social services (discussed in Chapter 2), but does include referrals to these services. While this separation may seem somewhat artificial, the Committee felt it was necessary to accurately describe the evidence related to needle and syringe exchange. The following two sections then examine alternatives to NSE for providing access to clean injecting equipment. One of these two sections focuses on pharmacy and prescription sales, vending machines, and supervised injecting facilities, while the other section focuses on disinfection distribution and education programs. The chapter then evaluates empirical evidence on the effectiveness of outreach and education in preventing HIV transmission among IDUs. Outreach and education are sometimes part of multi-component HIV prevention programs, as they are often used to direct drug users to services such as needle and syringe exchange. They can also stand alone as a means of educating IDUs on HIV prevention, and can also be used to refer drug users to drug treatment and other health and social services. The final section of the chapter discusses specific areas in need of further research in high-risk countries. NEEDLE AND SYRINGE EXCHANGE To evaluate the effectiveness of NSE, the Committee reviewed studies identified by a literature review (see Appendix B). As discussed in Chapter 2, the Committee then used a structured qualitative method based on an approach developed by the GRADE Working Group to evaluate the strength of the evidence (GRADE Working Group, 2004) (see Chapter 2 for further detail). The majority of evidence on the effectiveness of NSEs comes from observational studies, including numerous prospective cohort studies, supplemented by results from ecological and cross-sectional studies. (Appendix D provides a summary of these studies, grouped by study design.) The Committee did not identify any randomized controlled trials of NSE. This is not completely unexpected for such a public health intervention, particularly one with such immediacy and assumed efficacy and face validity. The Committee identified three case-control studies. Such studies enroll participants based on the presence or absence of a disease, and then com-
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pare the characteristics of a previous exposure to NSE. The Committee identified 26 prospective cohort studies, which enroll participants based on their risk characteristics, and follow them to compare related outcomes. The committee felt that 14 of these studies were especially strong in terms of study design and relevance (and noted those studies with an asterisk in a table in Appendix D). Case-control and prospective cohort studies were ranked as having the strongest available study design. The Committee also identified six ecological studies, which examine populations rather than individuals and cannot establish causal links. Finally, the Committee identified many cross-sectional and serial cross-sectional studies. Cross-sectional studies describe the associations between a disease and risk factors in a population at a specific point in time. The Committee considered such studies as having the weakest design because causal inferences cannot be drawn from them. Serial cross-sectional studies examine groups of people at multiple time points, and offer stronger evidence of shifts in associations over time. As opposed to prospective cohort studies which examine individual-level changes in risk behavior, well-designed serial cross-sectional studies can indicate patterns of behavior change at the community level. As supporting evidence, the Committee included six cross-sectional and four serial cross-sectional studies in Appendix D, based on their strong study design and relevance to the Committee’s statement of task. The Committee used caution in interpreting the results of studies reviewed in this chapter because of their generally weak designs and serious limitations. One limitation is that the studies identified do not randomly assign subjects to treatment and control groups—rather, participants deliberately choose whether to use NSEs and other services. This creates an unavoidable risk of selection bias, and means that differences in rates of risk behaviors and HIV infection may not be due to use of the service itself. Another limitation is that the study designs generally do not allow separate examination of program elements, so the independent contribution of improving access to sterile needles and syringes cannot be assessed. For example, NSE is often one component of a multi-component HIV prevention program, making it difficult to isolate the exact effects of NSE alone. Another concern is that studies of drug abuse, like most behavioral research, depend heavily on self-reported data on drug use, risk behavior, and precautions taken to reduce risk. Studies evaluating the effectiveness of NSEs are no exception. Self-reported data can introduce bias, as drug abuse is illegal in most settings, and drug users may underestimate risk behavior and overestimate protective behavior. Still, the self-reports of drug users on the incidence of drug abuse and drug-related risks have generally been shown to be valid (Darke, 1998) and remain the major type of outcome measures used in studies of NSE.
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Studies comparing audio computer-assisted self-interviews with interviewer-administered surveys show that IDUs tend to under-report risk behavior such as needle sharing (Metzger et al., 2000; Des Jarlais et al., 1999) and over-report protective behaviors such as condom use and syringe disinfection (Macalino, 2002) in face-to-face interviews. However, Safaeian et al. (2002) compared self-reports to NSE records and found that the majority of self-reports of NSE attendance in Baltimore were valid. This study also found that persons who over-reported NSE attendance were more likely to have injected frequently (adjusted odds ratio [AOR]=1.29; 95% confidence interval [CI]: 1.04–1.61), denied needle sharing (AOR=0.69; 95% CI: 0.52–0.89), and seroconverted to HIV (AOR=1.83; 95% CI: 1.11–.01). In the Baltimore study, model predictors of HIV infection based on self-reports compared with actual program data underestimated the protective effect of NSE participation by 18 percent (Safaeian et al., 2002). Evaluations of NSE often include a range of outcome measures (see Box 3.1). Desirable outcomes may include a reduction in high-risk behavior, more referrals to drug treatment, and declines in rates of HIV infection. Negative outcomes may include more frequent injection among participants, new initiates to injecting drug use, greater drug use in the community, and more needles discarded in public places. In the following sections, BOX 3-1 Potential Outcomes from Needle and Syringe Exchange Drug-related risk behavior Sex-related risk behavior Frequency of drug use Number of sexual partners Frequency of injection Frequency of unprotected sex Frequency of equipment sharing Sale of sex for drugs or money Use of disinfectant Number of injecting partners Unintended consequences Links to health and social services Recruitment of new IDUs Referral to services Increase in unsafe disposal of needles Extent of use of services Increase in prevalence or frequency of drug use Referral to drug treatment Incidence/prevalence HIV Hepatitis C Hepatitis B
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the Committee presents evidence categorized by outcome measure, including the impact of NSEs on drug-related and sex-related risk behavior, the impact of NSEs on HIV incidence and prevalence, any unintended consequences, and the impact of NSEs on links to health and social services. Drug-Related Risk Behavior The Committee did not identify any case-control studies that examined the impact of multi-component programs that include needle and syringe exchange on drug-related risk behavior. As noted, the Committee considered prospective cohort studies the strongest study design along with case-control studies. Of 26 prospective cohort studies identified, 18 examined the impact of these programs on drug-related risks. Thirteen found that participation in multi-component programs that include needle and syringe exchange reduced self-reported needle sharing. (Sharing is defined as lending or borrowing used needles or syringes.) Four studies found no increase in injection frequency among NSE participants, and one of these found a decrease (see Appendix D and Table 3.1). The sections below discuss studies selected by the Committee for their strong study design and relevance. Sharing drug preparation equipment such as cookers used to melt drugs, cotton used to filter out particles when drawing the drug into the syringe, and water used to rinse syringes, has been associated with hepatitis C (HCV) infection (Diaz et al., 2001; Hagan et al., 1999, 2001; Hahn et al., 2002; Thorpe et al., 2002). Few studies have examined whether NSEs reduce the sharing of other injection equipment such as cookers, cotton, or water—possibly because NSEs do not always provide such equipment. One prospective cohort study by Ouellet et al. (2004) shows that when NSEs do provide such drug paraphernalia, sharing declines. A cross-sectional study in Providence, Rhode Island, where an NSE provides alcohol swabs and cookers, supports this finding (Longshore et al., 2001). Two prospective cohort studies found no association between NSE use and the sharing of other injecting equipment (Hagan et al., 2000; Huo et al., 2005). In 2004 in Chicago, Ouellet et al. compared NSE users (n=558)—defined as those who obtained at least half their needles from an NSE—to non-users (n=175). Non-users were recruited from a neighborhood that did not have an NSE. Using multivariate analysis, the researchers found that regular NSE users were less likely to share needles (AOR=0.30; 95% CI: 0.19-0.46), lend used needles (AOR=0.47; 95% CI: 0.31–0.71), or use a needle for more than one injection (AOR=0.15; 95% CI: 0.08–0.27). Similarly, Bluthenthal and colleagues (2000) interviewed 340 street-recruited IDUs semi-annually to determine whether NSE use was associated with a decrease in syringe sharing. IDUs participating in the study also received HIV testing and counseling at the time of interview. The study
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found that 60 percent reported cessation of syringe sharing. Compared with non-NSE users, IDUs who began using an NSE were more likely to stop sharing syringes (AOR=2.68; 95% CI: 1.35–5.33), as were those who continued using the NSE (AOR=1.98; 95% CI: 1.05–3.75). Schoenbaum and colleagues (1996) studied the injection behavior of NSE users and non-users in the Bronx, New York City. The study found that male gender, HIV-seropositive status, and younger age were independently associated with NSE attendance, and that NSE users shared needles less often than non-users (p<0.05). A study by Gibson et al. (2002) examined whether NSE use is protective against high-risk behavior such as more frequent injection and syringe borrowing. The study sample included 338 untreated opiate-addicted IDUs, 77 percent of whom were included in follow-up (n=212). The study found that NSE users did not differ from non-users in injection frequency, but were less likely to report borrowing a used syringe. In univariate analysis, NSE use was protective against HIV risk (OR=0.45; 95% CI: 0.21–0.92). Multivariate analyses were used to correct for potential differences between IDUs who use NSE versus those who choose not to. These analyses found that NSE use had a more than six-fold protective effect against HIV risk behavior among IDUs using NSE as their sole source of syringes. In Baltimore, Vlahov et al. (1997) examined the drug-related behavior of 221 NSE participants at entry into the NSE, 2 weeks after entry, and 6 months after entry. At 6-month follow-up, reductions were reported in using a previously used syringe, lending syringes, backloading (drawing drug into a syringe and then transferring a portion into a second syringe by removing the plunger), and sharing cookers and cotton. A few studies have found that NSEs have no effect on drug-related risk behavior. For example, in a prospective cohort study in Amsterdam, Hartgers et al. (1992) found that NSE users did not borrow needles and syringes more or less often than non-NSE users. A cross-sectional study by Hagan et al. (1993) interviewed NSE users and asked about injection behavior during the month before first use of the NSE and the most recent month since starting to use the NSE. The study found no change in self-reported frequency of injection, but did find a decline in self-reported frequency of unsafe injection. Based on this evidence, the Committee concludes: Conclusion 3-1: Nearly all programs included in our literature search combine needle and syringe exchange with other components such as outreach, risk reduction education, condom distribution, bleach distribution and education on needle disinfection, and referrals to substance abuse treatment and other health and social services.
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TABLE 3-1 Studies with Drug-Related Risk Outcomes Study Result Bluthenthal et al., 2000, California (prospective cohort)+ NSE users decreased syringe sharing. Bruneau et al., 2004, Montreal (prospective cohort)+ NSE and pharmacy users less likely to stop injecting. Cox et al., 2000, Ireland (prospective cohort) NSE users decreased needle and syringe sharing and frequency of drug use. Des Jarlais et al., 2000, New York City (ecological) Injection risk behaviors declined significantly in presence of NSE. Gibson et al., 2002, California (prospective cohort)+ NSE users decreased syringe sharing; no change in injecting frequency. Hagan et al., 2000, Seattle, Washington (prospective cohort)+ NSE users less likely to inject with a used syringe; no association with sharing of other injection equipment. Hagan et al., 1993, Tacoma, Washington (cross-sectional) NSE users report no change in frequency of injection; the frequency of unsafe injection declined. Hammett et al., 2006, Vietnam and China (serial cross sectional) Drug-related risk behavior declined in frequency. Hart et al., 1989, London (prospective cohort) NSE users decreased syringe sharing; no increase in frequency of injection. Hartgers et al., 1992, Amsterdam (prospective cohort) No difference in sharing between NSE users and non-users. Huo et al., 2005, Chicago (prospective cohort + NSE users less likely to share syringes; no association with sharing of other injection equipment. Keene et al., 1993, Wales (cross-sectional)+ NSE users less likely to share syringes. Klee et al., 1991, UK (cross-sectional) NSE users more likely to lend syringes. Longshore et al., 2001, Providence, Rhode Island (cross-sectional) NSE users less likely to report syringe sharing; more likely to report cleaning their skin; less likely to report sharing cookers. Marmor et al., 2000, New York City (prospective cohort) NSE users decreased rates of drug injecting. Monterroso et al., 2000, multiple U.S. cities (prospective cohort) NSE users less likely to share needles and syringes. Ouellet et al., 2004, Chicago (prospective cohort)+ NSE users decreased sharing of needles, syringes, and other equipment. Schoenbaum et al., 1996, New York City (prospective cohort)+ NSE users shared less than non-NSE users. Van Ameijden and Coutinho, 1998, Amsterdam (prospective cohort) NSE users showed large initial reduction in sharing needles and frequency of injection. Van Ameijden et al., 1994, Amsterdam (serial cross sectional) NSE users are less likely to reuse needles/syringes.
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Study Result Van den Hoek et al., 1989, Amsterdam (prospective cohort) NSE users decreased needle and syringe sharing; no increase in frequency of drug use. Vazirian et al., 2005, Iran (cross-sectional) NSE users decreased needle/syringe sharing. Vertefeuille et al. 2000, Baltimore (prospective cohort) NSE users decreased syringe sharing; increased participation in drug treatment. Vlahov et al., 1997, Baltimore (prospective cohort) NSE users decreased syringe sharing. Watters et al., 1994, San Francisco (serial cross-sectional) NSE users reported decrease in frequency of injection; less likely to share needles/syringes. Wood et al., 2002, Vancouver (prospective cohort)+ NSE users less likely to share needles and syringes. Wood et al., 2003, Vancouver NSE users more likely to frequently inject (prospective cohort) cocaine; more likely to safely dispose of syringes. + Indicates that the study compared NSE users with non-users. Conclusion 3-2: Moderate evidence from a large number of studies and review papers—most from developed countries—shows that participation in multi-component HIV prevention programs that include needle and syringe exchange is associated with a reduction in drug-related HIV risk behavior. Such behavior includes self-reported sharing of needles and syringes, safer injecting and disposal practices, and frequency of injection. Sex-Related Risk Behavior Few studies have evaluated the effect of NSEs on sex-related HIV risk behavior (see Table 3-2). This is not surprising, because reduction in sexual risk (often evaluated by reports of condom use) is often not a primary goal of NSEs. However, two early prospective cohort studies associated use of an NSE with a decline in the number of sexual partners (Donoghoe et al., 1989; Hart et al., 1989). Donoghoe and colleagues measured the sexual behavior of 142 NSE clients in England and Scotland at baseline and 2 to 4 months later. Seventy-seven percent of clients reported having one or more sexual partner in the 3 months prior to the first interview. Forty-six percent of these sexually active clients had non-IDU partners. At follow-up, the number of NSE clients having no sexual partners increased from 23 to 31
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TABLE 3-2 Studies with Sex-Related Risk Outcomes Study Result Donoghoe et al., 1989, UK (prospective cohort) Number of NSE participants having no sexual partners increased; number having multiple sexual partners decreased. Hart et al., 1989, London (prospective cohort) Significant correlation between multiple sexual partners and condom use; and a reduction in the proportion of clients with multiple partners. Cox et al., 2000, Ireland (prospective cohort) NSE users reported no significant change in levels of condom use. percent, and the number having multiple partners decreased slightly from 26 to 21 percent. Hart et al. (1989) monitored an NSE in London and followed 121 NSE clients from November 1987 to October 1988. Clients were interviewed 1 month after entry into the NSE and again three months later. The study found a highly significant correlation between multiple sexual partners and condom use, and a reduction in the proportion of NSE clients with multiple partners. Based on this evidence, the Committee concludes: Conclusion 3-3: Needle and syringe exchange is not primarily designed to address sex-related risk behavior. In two early prospective cohort studies, NSE participants reported decreases in sex-related risk behavior. However, this issue has not been well studied, and the existing modest evidence is insufficient to determine the effectiveness of needle and syringe exchange in reducing sex-related risk. Effects of NSE on HIV Incidence/Prevalence Few site-specific studies have explored the relationship between NSE participation and HIV incidence, although several ecological studies have found positive associations between the introduction or presence of NSEs and reduced HIV prevalence and incidence (see Table 3-3). As mentioned, whether NSE alone is responsible for the impacts is unclear, given myriad design and methodological issues noted in the majority of studies. Two prospective cohort studies from Montreal and Vancouver in the 1990s associated NSE participation with higher risk of HIV seroconversion (Strathdee et al., 1997; Bruneau et al., 1997). In Montreal, Bruneau et al.
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TABLE 3-3 Studies with HIV Incidence or Prevalence Outcomes Study Result Bruneau et al., 1997, Montreal (prospective cohort) Increased HIV seroconversion among NSE users. Des Jarlais et al., 2005a, New York City (ecological) From 1990–2001, HIV prevalence declined. Des Jarlais et al., 2005b, New York City (serial cross-sectional) Strong negative relationship between the number of syringes exchanged and estimated HIV incidence. Hammett et al., 2006, Vietnam and China (serial cross-ectional) HIV prevalence among IDUs declined in Vietnam and remained stable in China. Hurley et al., 1997, worldwide (ecological) Increased HIV prevalence in cities without NSE. MacDonald et al., 2003, worldwide (ecological) Increased HIV prevalence in cities without NSE. Mansson et al., 2000, Sweden (prospective cohort) No new HIV cases during a median of 31 months among NSE participants. Patrick et al., 1997, Vancouver (case control) No association with frequency of NSE use and HIV seroconversion. Schechter et al., 1999, Vancouver (prospective cohort) Cumulative HIV incidence was significantly elevated in frequent NSE attenders. Strathdee et al., 1997, Vancouver (prospective cohort) Increased HIV and HCV prevalence in the presence of NSE. Van Ameijden et al., 1992, Amsterdam (case control) No association between NSE participation and HIV seroconversion. (1997) used three risk-assessment approaches to examine the association between NSE use and HIV infection. All three analytical approaches associated NSE attendance with a substantial and consistently higher risk of HIV infection. For example, in the cohort approach, in which there were 89 incident cases of HIV infection, the researchers found a 33 percent cumulative probability of HIV seroconversion for NSE users, compared with a 13 percent probability for non-users. In the nested case-control study, consistent NSE use was associated with HIV seroconversion during follow-up (OR=10.5; 95% CI: 2.7–41.0). The analyses employed methodologies to control for a range of confounders, including drug of choice and frequency of injecting drug use in the previous month. These findings persisted after controlling for confounders. The authors and commentators on this research pointed out that the Montreal NSE appeared to have attracted high-risk cocaine injectors, who injected much more often than heroin users. Also, as shown by the seroprevalence data at baseline, Montreal NSE users had high baseline rates of HIV and hepatitis B infection (Bruneau et al., 1997). The NSE also originally strictly limited the number of needles and syringes users could
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receive during any one visit. The authors further noted that the ready availability of clean injecting equipment through pharmacies might have meant that the NSE attracted marginalized, high-risk individuals (Bruneau et al., 1997). These early research results prompted the Montreal NSE to remove limits on the number of needles and syringes users could obtain, to provide access to other injection equipment, and to expand the number of distribution points to 25 (Personal communication, Carole Morissette and Pascale Leclerc, Health Protection Sector, Public Health Department, Agence de Santé et Des Services Sociaux de Montréal, June 6, 2006). In addition to syringes, NSEs began to provide alcohol swabs, individual disposal containers, sterile water vials, and “stericups” (kits containing a filter, cooker, and post-injection swab). Of 429 pharmacies in Montreal, injection equipment is available at roughly 40 percent, and some (n=70) sell kits containing four syringes, condoms, alcohol swabs, sterile water vials, stericups, and education material for $1. Following these changes, HIV incidence among participants in the Montreal SurvUDI study dropped from 6.1 per 100 person-years in 1995 to 4.7 per 100 person-years in 2004. The SurvUDI study is a surveillance network that began in 1995 and targets hard-to-reach, mostly out-of-treatment IDUs in Eastern Central Canada (Hankins et al., 2002). HCV incidence—reported retrospectively among Montreal SurvUDI participants between 1997 and 2003—remains high, at about 26 per 100 person-years. (Personal communication, Carole Morissette and Pascale Leclerc, Health Protection Sector, Public Health Department, Agence de santé et des services sociaux de Montréal, June 6, 2006). The SurvUDI network also provides data on trends in syringe sharing in Montreal, including the proportion of participants injecting with a syringe used by someone else (at first study participation). That proportion fell from 45 percent in 1995 to 28 percent in 2004. In Vancouver, Strathdee et al. (1997) also found that frequent NSE attendance was an independent predictor of HIV seroconversion. After adjusting for confounders, the authors found that the adjusted odds ratio for HIV infection status among NSE users compared with non-NSE users was 1.68. The authors noted that cocaine was the drug of choice among 72 percent of HIV-seropositive IDUs, and that cocaine puts IDUs at elevated risk because it is associated with more frequent injection (Anthony et al., 1991; Chaisson et al., 1989). A follow-up study by Schechter et al. (1999) in the same setting found no relationship between NSE use and HIV incidence, and a case-control study found borrowing of syringes to be the most significant behavior associated with seroconversion among IDUs (Patrick et al., 1997). After multivariate analysis controlling for confounders, the au-
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ing needles and syringes—and enhance legal access via pharmacy sales, voucher schemes, and physician prescription programs—have focused on assessing the acceptability of such programs by drug users, pharmacists, and physicians. A few studies have examined the impact on drug-related HIV risk, and found suggestive evidence of a reduction. The evidence regarding supervised injecting facilities and vending machines—while encouraging—is insufficient for drawing conclusions on the effectiveness of these interventions in reducing drug-related HIV risks among IDUs. As with drug treatment, a common concern is that sterile needle and syringe access may produce unintended results, including more new drug users, expanded networks of high-risk users, more frequent injection, and more discarded needles in the community. While few studies have specifically examined such outcomes, studies to date have not found evidence of negative effects. More research is needed on potential unintended consequences of HIV prevention programs that include needle and syringe access, and strategies to address such problems if they are found. Undiluted bleach can inactivate HIV on injecting equipment in the laboratory, and in the field if used according to guidelines. However, in practice, injecting drug users do not use bleach correctly, so programs that distribute bleach should also educate drug users on proper techniques. In some countries, bleach is not available or acceptable, and it may be necessary to use other disinfectants. Drug users should rely on such methods only when they cannot stop injecting, or do not have access to new equipment. More research is needed to identify the simplest and most acceptable effective disinfection techniques using bleach and the best methods for educating IDUs on these techniques as well as the effectiveness of alternative disinfectants in field settings, particularly in countries where bleach is not available or acceptable. Outreach-based efforts to prevent HIV transmission—which may direct drug users to needle and syringe exchange, for example—are associated with reductions in drug-related risk behavior, including injection frequency and sharing of injection equipment. Outreach is effective in linking hard-to-reach IDUs with drug treatment and other health and social services. The impact of outreach on sex-related HIV risk behavior is less clear and more research is needed to study this impact. More research is also needed to determine the best way to integrate effective strategies for reducing sexual risk behavior and sexual transmission of HIV among IDU into outreach and education programs. Although questions remain about the contribution of individual elements of multi-component programs that include sterile needle and syringe access and outreach and education on risk behavior and actual HIV incidence, the report recommends that high-risk countries act now to implement such programs. These programs should include multiple access points
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