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Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence (2007)

Chapter: 3 Sterile Needle and Syringe Access and Outreach and Education

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Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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-

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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

 

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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-

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

thors found no association between frequency of NSE use and seroconversion.

As in Montreal, the Vancouver NSE originally operated with strict limits on the number of needles and syringes that users could exchange at any one time, and the program operated in only one location. The Vancouver program also made dramatic changes in response to early results. Specifically, the NSE switched from a limited exchange approach to a need-based approach—allowing unlimited distribution of needles/syringes—and greatly increased the number of access points. The program also began offering a variety of distribution methods, including fixed, mobile, and home delivery. HIV incidence among IDUs has since fallen by 30 percent (Personal communication, Chris Buchner, Vancouver Coastal Health Authority, May 5, 2006).

Several studies in Amsterdam found no significant relationship in either direction between NSE participation and HIV incidence (van Ameijden et al., 1992; Coutinho, 2005). Several other papers by these authors (van Ameijden and Coutinho, 1998, 2001) found initial reductions in risk behavior after NSE and other interventions began, but no further reductions over time. These studies also found that NSE was not associated with an increase in injecting drug use, and attributed declines in injecting to cultural and ecological factors. Krol (2006) reached the same conclusion.

Several ecological studies from the developed world found that early, comprehensive programs of outreach, prevention, education, and access to sterile injecting equipment may prevent the expansion of IDU-driven epidemics. Ecological studies, as well as serial cross-sectional studies, reflect community-level patterns of prevalence and risk behaviors rather than patterns or changes at the individual level. For example, Des Jarlais et al. (1995) examined five cities (Glasgow, Scotland; Lund, Sweden; Sydney, Australia; Tacoma, U.S.; and Toronto, Canada) where HIV was introduced into the IDU population but infection rates remained below 5 percent for at least 5 years. The authors found that all five cities had pursued early prevention activities, such as offering sterile injection equipment and community-based outreach. Such interventions may also help reduce HIV prevalence and incidence among IDUs in more mature HIV epidemics, such as in New York City (Des Jarlais et al., 2005a).

In a study of 81 cities, Hurley and colleagues (1997) found that annual HIV seroprevalence between 1988 and 1993 rose by 5.9 percent in 52 cities without NSEs, and fell by 5.8 percent in 29 cities with NSEs. In a similar analysis of 99 cities, MacDonald and colleagues (2003) found that annual HIV prevalence fell by 18.6 percent in cities that introduced NSEs, and rose by 8.1 percent in cities without NSEs. Critics objected that this study did not account for the stage of the epidemic in these cities, and that the researchers used different protocols to collect data on seroprevalence in

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

different populations (Käll, 2005). To address the possibility that the effect of NSEs can vary with the stage of epidemic, both Hurley et al. and MacDonald et al. analyzed cities where the initial measured seroprevalence among IDUs was less than 10 percent. In the Hurley et al. study, the authors did not find a significant association between NSE presence and the trajectory of the epidemic. However, MacDonald and colleagues did find a significant relationship: the mean annual weighted increase in HIV prevalence was 32.1 percent in cities that did not introduce NSEs, compared with a mean annual decrease of 7.8 percent in cities with NSEs (p=0.03).

Multiple studies show that NSEs do not reduce transmission of HCV, which has been attributed to the apparent failure of NSEs to provide enough ancillary injecting equipment such as sterile cotton, water, and alcohol wipes. While NSEs do reduce the frequency of reported needle and syringe sharing, they do not appear to reduce the sharing of other injecting equipment, such as cookers, cotton, rinse water, and drug solution (Hagan and Thiede, 2000; Sarkar et al., 2003; Taylor et al., 2000; Mansson et al., 2000). In contrast, a case-control study by Hagan et al. (1995) in Seattle found that NSE attendance was associated with a six-fold decrease in acquisition of hepatitis B virus (HBV), and a seven-fold decline in HCV acquisition. Given the high prevalence of HCV among IDUs, this represents an important area for future research.

Based on this evidence, the Committee concludes:

Conclusion 3-4: Four ecological studies have associated implementation or expansion of HIV prevention programs that include needle and syringe exchange with reduced prevalence of HIV in cities over time and after considering the local prevalence of HIV at the time of program implementation or expansion—although a causal link cannot be made based on these studies. The evidence of the effectiveness of NSE in reducing HIV prevalence is considered modest, based on the weakness of these study designs.


Conclusion 3-5: Moderate evidence indicates that multi-component HIV prevention programs that include needle and syringe exchange reduce intermediate HIV risk behavior. However, evidence regarding the effect of needle and syringe exchange on HIV incidence is limited and inconclusive.


Conclusion 3-6: Five studies provide moderate evidence that HIV prevention programs that include needle and syringe exchange have significantly less impact on transmission and acquisition of hepatitis C virus than on HIV, although one case-control study shows a dramatic decrease in HCV and HBV acquisition.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×
Mathematical Models

A previous National Research Council and Institute of Medicine (IOM) report (NRC and IOM, 1995) and a University of California review (Lurie et al., 1993) reviewed mathematical models and their conclusions regarding the impact of NSE on HIV incidence. Thus this section will examine such models only briefly, and the evidence presented is considered supplementary to the empirical studies described above.

Mathematical models used by Kaplan and colleagues (Kaplan and Heimer, 1992; Kaplan and O’Keefe, 1993) used a set of two dynamic equations and their associated steady states to link the size of NSE programs to HIV incidence in injecting equipment and IDUs (Kaplan and O’Keefe, 1993). A syringe tracking system developed for this purpose allowed the researchers to assess infection rates in injecting equipment directly from an existing NSE in New Haven, Connecticut. The researchers used those rates to infer the impact of New Haven’s needle and syringe exchange on HIV incidence among IDUs. A key finding was that the NSE reduced steady state prevalence in injecting needles by one-third. From this, the researchers deduced that HIV incidence also fell by one-third in steady state. A separate modeling exercise showed that annual HIV incidence fell by 1–3 per 100 participant-years.

More recently, a variant of this mathematical framework has been used to assess the impact of extending coverage of needle distribution programs on HIV transmission among injecting drug user populations of Belarus and the United Kingdom when injectors share needles in the confines of small sub-groups of the population (Vickerman et al., 2006). Its main finding, based on simulations, is that the biggest reductions in steady-state HIV prevalence usually occur only after certain threshold levels of service coverage have been achieved.

Questions have been raised about the underlying technical assumptions of mathematical models in general and specifically the New Haven studies. One concern is whether the law of conservation of needles—a key element of the Kaplan model—is valid in practice. This law requires that the number of new needles handed out and the number handed in be roughly the same. This was the case with the New Haven NSE, and the weight of evidence for other NSE programs supports this assumption (Guydish et al., 1991; Ksobiech, 2004).

A second issue is whether the composition of program participants changed over time—for instance, whether persons more likely to be HIV-seropositive dropped out of the program and were replaced by persons less likely to be HIV-seropositive. Under this scenario, the model would tend to overestimate the effectiveness of NSE. Kaplan et al. (1994) argue that little evidence suggests that such a shift occurred in the New Haven NSE.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
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A third area of concern is the model’s relative lack of attention to behavioral aspects of HIV transmission. For instance, Bloom et al. (2006) argue that needles turned in to the needle exchange program are likely to be older and to have been used more frequently—not a random selection of circulating needles. Thus infection rates among these old needles are likely to be “terminal” rather than “average.” These two rates can sometimes move in opposite directions, so the data for New Haven may not offer ready insight into the impact of NSE on HIV incidence among humans. Additionally, in the case of the model used for the Belarus and United Kingdom study (Vickerman et al., 2006), we do not know how the size and composition of injecting drug user sharing groups respond to needle distribution programs and hence their efficacy in reducing HIV transmission.

After evaluating these concerns, the IOM review (NRC and IOM, 1995) concluded: “The model-based evaluation of the New Haven needle exchange program provides important insights into the dynamics of such programs and useful preliminary estimates of their efficacy. We cannot attach the same level of confidence to these model-based estimates as we could to evaluation programs that included a suitable control group in which individuals were tested (directly) for HIV infection” (p. 231).

While there are questions about specific numerical estimates of the efficacy of needle exchange programs derived from mathematical models of HIV transmission among IDU, such models do have the advantage of illustrating the relationships among the major parameters such as the probability of transmission, the size of needle sharing groups and the frequency of shared needle use that influence the transmission of HIV among IDU. Moreover, models can highlight some common areas of concern such as how the relatively high probability of transmission of HCV from a single unsafe injection means that even if needle exchanges achieved high coverage rates, they would be much less efficacious in preventing HCV than HIV.

Unintended Consequences of Needle and Syringe Exchange

This section reviews evidence regarding the effect of NSE on the frequency of drug use, the recruitment of new injecting drug users, unsafe disposal of needles, and trends in crime. The Committee did not identify any studies that focus on these outcomes as their main objective, but some studies report them as secondary outcomes.

Of the prospective cohort studies (see Appendix D), five found no increase in frequency of injecting among NSE attenders (Hart et al., 1989; van Den Hoek et al., 1989; Cox et al., 2000; Gibson et al., 2002; Marmor et al., 2000). Hart et al. (1989) found that the frequency of injecting did not increase among NSE clients in London, and that the incidence of drug use-related abscesses fell among this group. van Den Hoek et al. (1989) found

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
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no increase in the proportion of participants injecting drugs or the frequency of drug use among 263 IDUs in Amsterdam. A serial cross-sectional study in San Francisco found that NSE users reported a drop in injections from 1.9 to 0.7 per day (Watters et al., 1994).

Other studies suggest that programs that include NSE do not increase the number of new IDUs. During a 5.5-year study period, Watters et al. (1994) found that the proportion of persons who reported first injecting drugs in the previous year decreased from 3 to 1 percent. In Tacoma, Washington, Hagan et al. (1993) found no increase in drug use. The study measured initiation into drug use by collecting injection histories of NSE users. Only 1 of 204 users began using drugs after the NSE opened, and only 13 users had started injecting in the previous 2 years. In Vancouver, when NSE users were asked where they had met their new sharing partners, only 1 of 498 cited the NSE (Schechter et al., 1999).

Studies have not linked NSEs to a higher number of discarded used needles (Oliver et al., 1992; Broadhead et al., 1999; Doherty et al., 2000). A prospective study in Ireland by Cox et al. (2000) found that at 6-month follow-up, the proportion of NSE users discarding needles in the street, alley, sewer, or gutter declined from 28.2 percent to 15.6 percent (p<0.001), and the proportion discarding needles in the garbage or a dumpster fell from 42.4 percent to 29.1 percent (p<0.001). Similarly, a prospective study in Vancouver by Wood et al. (2003) found that NSE use was independently associated with safer syringe disposal (AOR=2.69; 95% CI: 1.38–5.21).

A study in Baltimore examined whether the introduction of a needle and syringe exchange was associated with increased crime rates (Marx et al., 2000). Using arrest records, the study compared trends in arrests in NSE areas and non-NSE areas of the city before and after introduction of the NSE. Arrest trends were modeled and NSE areas were compared to non-NSE areas. No significant differences were found (Marx et al., 2000). A cross-sectional study in an inner-city neighborhood of New York City assessed the association between proximity to an NSE and violence (Galea et al., 2001). Results showed no significant association between distance from the nearest NSE and reporting a fight (OR=1.05; p=0.89); robbery in the neighborhood in the previous 6 months (OR=1.13; p=0.71); having ever experienced violence (OR=0.72; p=0.52); or having ever been robbed by drug users (OR=1.05; p=0.91) (Galea et al., 2001).

Based on this evidence, the Committee concludes:

Conclusion 3-7: Few studies have specifically evaluated whether HIV prevention programs that include needle and syringe exchange lead to unintended consequences, such as increases in new drug users, more frequent injection among established users, ex-

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

panded networks of high-risk users, more discarded needles in the community, and changes in crime trends. Modest evidence shows that NSE does not increase the number of discarded needles in the community, and that injection frequency does not increase among NSE participants. Weak evidence and limited data suggest that programs that include NSEs do not lead to new users, expanded drug networks, or increases in crime.

Links to Health and Social Services

NSEs can serve as important links to health and social services for drug users who otherwise might not have access to treatment and care. Examples of such services include referrals to drug treatment, voluntary HIV counseling and testing, and medical care such as vaccinations and diagnosis of infections.

To assess the role of NSEs as a bridge to treatment, Strathdee et al. (1999) conducted a prospective cohort study in Baltimore. The study found that NSE attendance and health care use were each independently associated with entry into detoxification. HIV-seropositive NSE attenders were more than three times as likely to enter a detoxification program in the first year after the NSE began, but this result diminished over time. One explanation is that IDUs seeking treatment visited the NSE in large numbers when it first opened. A study at a New Haven NSE found that known syringe exchangers accounted for only 27 percent of requests for drug treatment (Heimer, 1998). Among the requesters, there was a strong association between heroin use and use of the NSE, and between alcohol use and non-users. This reveals that many people seeking drug treatment are not NSE clients, and that a treatment referral program could reach a larger target audience.

IDUs are likely to use services offered through an NSE beyond referrals for drug treatment. Porter et al. (2002) conducted a cross-sectional study at a needle and syringe exchange in Philadelphia offering four types of services: HIV voluntary counseling and testing, medical care, drug treatment referrals, and referrals to other services. The sample (n=43) included needle and syringe exchange users and non-users. Thirty-nine percent of the sample used at least one service besides needle exchange, with most of these participants using services that did not require outside follow-up. Twenty-eight percent had heard of at least one service beyond needle and syringe exchange, but had not used the additional service. Reasons for not using available services included access to these services through other means, and unwillingness to spend time waiting for them. The remaining study participants were either not aware that additional services existed or were aware that other services were available but had no knowledge of the

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
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specifics types. All the respondents who used the needle exchange fell into the first two categories, while non-users fell into the latter two.

Examining the characteristics of NSE participants associated with health care and drug treatment (n=269) in Baltimore, Riley et al. (2002) found that 58 percent reported using primary health care in the previous 3 years. Being age 40 years or older, having health insurance, and exchanging more than seven syringes per visit were positively associated with use of primary health care.

Some studies have illustrated the range of unique health services provided with NSEs. For example, a study by Grau et al. (2002) described a wound and abscess clinic incorporated into an NSE in Oakland, California. In New York City, an NSE administered influenza and pneumococcal vaccines to IDUs (Stancliff et al., 2000); while in Baltimore an NSE provided tuberculosis services (Riley et al., 2002).

Pollack et al. (2002) examined whether a mobile NSE-based health care delivery system reduced the use of hospital emergency rooms by out-of-treatment IDUs in New Haven. Of 373 IDUs, 117 were NSE clients and 256 were not. After the system was implemented, use of the emergency room fell among clients and rose among non-clients.

Based on this evidence, the Committee concludes:

Conclusion 3-8: Few empirical studies have evaluated whether HIV prevention programs that include needle and syringe exchange effectively link IDUs to ancillary health and social services. The few studies examining this issue show moderate uptake of these services among NSE attendees. However, none of the studies had comparison or control groups, so the overall use of such services among drug users who do not use NSE is unknown.

Summary Conclusion and Finding on Multi-Component HIV Prevention Programs that Include NSE

Summary Conclusion: Moderate evidence from developed countries points to a beneficial effect of multi-component HIV prevention programs that include needle and syringe exchange on injection-related HIV risk behavior, such as self-reported needle sharing and frequency of injection. Modest evidence also points to decreasing trends in HIV prevalence in selected cities studied over time. Although many of the studies have design limitations, the consistency of these results across a large number of studies supports these conclusions.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
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Finding 3-1: The Committee finds that almost all published studies of multi-component HIV prevention programs that include needle and syringe exchange originate in North America, Western Europe, and Australia.

ALTERNATIVE ACCESS TO STERILE NEEDLES AND SYRINGES

Pharmacy Access

Pharmacists can play a key role in preventing HIV infection among IDUs. They can provide advice, including information on safe needle use and substance abuse treatment, and also sell condoms and sterile needles and syringes (Jones and Coffin, 2002). In the United States, many states have “deregulated” or removed laws to allow increased access to sterile needles and syringes through pharmacy sales or physician prescription (Burris et al., 2003). As noted in Chapter 1, syringe prescription laws prohibit the sale of needles and syringes without a prescription and pharmacy regulations may limit the number of syringes a person can purchase at one time (Burris et al., 2003). Relaxation of such laws and regulations governing pharmacy sales of syringes has improved attitudes toward selling to injecting drug users, and increased the number of IDUs who turn to pharmacies for clean injecting equipment (Coffin et al., 2002; Deren et al., 2006).

A well-studied example of the effects of deregulating the availability of syringes through pharmacies is the New York Expanded Syringe Access Demonstration Program (ESAP). This program began in 2001 by allowing pharmacies, health care facilities and practitioners to register and provide up to 10 syringes without a prescription to persons at least 18 years old (Klein et al., 2002). Studies show that IDUs began using pharmacies as a result of this legislation (Deren et al., 2003; Des Jarlais et al., 2002; Fuller et al., 2004).

A serial cross-sectional study by Pouget et al. (2005) found that self-reports of receptive sharing fell significantly—from 13.4 percent in 2001 to 3.6 percent in June 2003 following the legislative change. The number of IDUs obtaining syringes from an ESAP source, mostly pharmacies, rose from 7.5 percent to 25 percent. Deren et al. (2006) examined syringe sources pre- and post-ESAP (n=130). Most drug users who reported obtaining syringes at an NSE before ESAP began continued using that source, although 10 percent reported some use of ESAP. Of drug users who originally relied on unsafe sources, 19 percent reported some ESAP use. Overall, 14 percent of the sample reported some ESAP use.

Other regions of the United States have also experimented with this form of alternative access. Groseclose et al. (1995) examined syringe-

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

sharing practices before and after Connecticut partially repealed laws requiring prescriptions for needles and drug paraphernalia. Syringe sharing fell from 52 percent to 31 percent (p=0.02) after the change in laws, and 78 percent of IDUs purchased syringes from a pharmacy, compared with 19 percent before.

Singer et al. (1997) surveyed pharmacists in Hartford and its peripheral neighborhoods to study access to over-the-counter syringes. Results showed that 72.2 percent of inner-city pharmacies and 55.6 percent of periphery pharmacies sold syringes without prescription. Some pharmacists cited negative incidents as their reason for requiring a prescription for syringes. Examples of such incidents included improper disposal of used syringes in or near the pharmacy, drug use on pharmacy property, and increased shoplifting.

In a cross-border HIV prevention project for IDUs in China and Vietnam, peer educators distribute sterile needles and syringes directly, as well as vouchers for sterile needles and syringes and other prevention supplies that drug users may redeem at participating pharmacies (Hammett et al., 2005). In Vietnam, the voucher scheme has proved very popular among IDUs: about two-thirds of all needles and syringes provided by the project over 3 years occur through vouchers, with about 8,000 redeemed per month. In China, the vouchers were initially popular, but the novelty appears to have worn off quickly, and most IDUs now prefer to receive needles and syringes directly. This difference between the two countries may reflect differences in concerns about police, the convenience of pharmacy locations, and pharmacists’ attitudes toward IDUs (Hammett et al., 2005).

Attitudes of Pharmacists Toward Selling or Providing Syringes

Individual pharmacists can often decide whether to sell syringes without a prescription in areas where it is legal to do so. Many studies have examined the willingness of pharmacists to sell or provide syringes to IDUs, and the factors surrounding their decision. A study in Atlanta found that the personal attitudes and beliefs of individual pharmacists are the most influential factor (Taussig et al., 2002). Some pharmacists fear that IDUs will discard syringes unsafely, and that the presence of IDUs in their pharmacy will be bad for business, while others view syringe access as an HIV prevention method, and see drug dependence as a disease. In Denver, pharmacists viewing syringe sales as a method for preventing disease were more likely to sell syringes to IDUs (Lewis et al., 2002). Concerns also arose in that city, with pharmacists worrying about the effect of IDUs on business and the possibility of discarded syringes near the store.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
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In Rhode Island, most pharmacists who work in stores that sell non-prescription syringes (n=101) were willing to sell syringes to IDUs (65 percent), were in favor of providing syringe disposal containers (68 percent), and supported providing pamphlets on safe injecting practices (88 percent) (Rich et al., 2002).

Characteristics of IDUs Using Pharmacies for Sterile Needle and Syringe Access

Studies show that IDUs who use pharmacies tend to have lower risk profiles. Miller et al. (2002) compared risk behavior in Vancouver among IDUs who cited pharmacies, fixed NSE, and mobile exchange vans as their primary source of needles and syringes. Pharmacy users had the lowest risk profiles, although they continued to report needle sharing. Studies in Marseille, France (Obadia et al., 1999), and Baltimore, Maryland (Riley et al., 2000), suggest that drug users who rely on pharmacies for equipment are more socially integrated than those who rely on NSEs. As Vlahov (2000) noted, the availability of clean injecting equipment through pharmacies might result in the NSE attracting higher-risk IDUs. Therefore access to pharmacy syringes may influence the findings of studies that compare NSE users with non-users (Ouellet et al., 2004; Gibson et al., 2002; Bruneau et al., 1997).

Physician Prescription Access

The Committee identified one program that offered access to needles and syringes though physician-provided prescriptions. In 1999, a pilot project in Rhode Island aimed to offer medical services, access to syringes, risk reduction counseling, and referrals to other services through syringe prescriptions from physicians (Rich et al., 2004). On the first visit, the physician encouraged an IDU to undergo HIV testing and assessed the need for drug treatment and other services. For IDUs who said they would continue to inject despite advice not to, physicians prescribed up to 100 syringes, providing instructions for proper use and disposal. Participants could then request refills over the phone, and the health clinic made other injecting supplies available. The study found that the syringe prescription program was feasible, and that it attracted a high-risk, underserved IDU population. This type of program served as a link to care, and a basis for substance abuse treatment and other medical and social services. However, the evidence from this pilot study must be considered in light of the limitations associated with a case study.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
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Supervised Injecting Facilities

Supervised injecting facilities (SIFs)2 are legally sanctioned and supervised areas where drug users can use pre-obtained drugs in a safe atmosphere under hygienic conditions (Dolan et al., 2000). SIFs are designed to reduce the inappropriate disposal of injecting equipment, keep drug users off the street, reduce fatal and non-fatal overdoses, reduce the transmission of HIV and other bloodborne diseases, and improve access to health and social services. SIFs prohibit drug dealing and provide sterile injecting equipment, referrals to health care and drug treatment, and other services such as meals and showers.

SIFs have long existed in Europe, particularly in the Netherlands, Germany, Switzerland, and Spain (Dolan et al., 2000). In 2003, a pilot SIF opened in Vancouver, with the stipulation that it be vigorously evaluated. The SIF provides injecting equipment and emergency care in the event of an overdose, and an onsite addiction counselor provides referrals to treatment programs. The evaluation examined risk behavior, blood-borne infection transmission, overdoses, and the use of health services among a cohort of SIF users (Wood et al., 2004a).

In the first 18 months of the program, 4,764 individuals registered with the SIF (Tyndall et al., 2006). Heroin was injected 46 percent of the time. Although cocaine use is generally characterized by repeated injections, and only one injection is allowed per SIF visit, cocaine was injected 37 percent of the time. In a 12-month period, the SIF made 2,171 referrals—37 percent to addiction counseling (Tyndall et al., 2006).

A cross-sectional study based on the Vancouver SIF examined factors associated with syringe sharing (Kerr et al., 2005). Logistic regression analyses found that use of the SIF was independently associated with a three-fold reduction in syringe sharing (AOR=0.30; 95% CI: 0.11–0.82; p=0.02).

In terms of unintended consequences, a study by Wood et al. (2004b) examined injecting-related public disorder problems before and after the opening of the Vancouver SIF. The 12-week period after the SIF opened was independently associated with reductions in the number of IDUs injecting in public, and the number of discarded syringes and other paraphernalia. Wood et al. (2006a) examined crime rates in the surrounding area during the year before and the year after the SIF opened. The study relied on police records of drug trafficking, assaults and robberies, and vehicle break-ins and thefts. The study found no differences between the 2 years

2

Supervised injecting facilities are also known as drug consumption facilities, safer injecting facilities, supervised injecting centers, and medically supervised injecting centers.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
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with respect to these crimes. Similarly, a study by Wood and colleagues (2006b) showed that SIFs were unlikely to result in reduced use of addiction treatment services. In multivariate analyses, an average of at least weekly use of the SIF (relative hazards=1.72; 95% CI: 1.25–2.38) and contact with the SIF’s addiction counselor (relative hazards=1.98; 95% CI: 1.26–3.10) were both independently associated with faster entry into a detoxification program.

SIFs are known as medically supervised injecting centers (MSIC) in Australia. In 2003, a report evaluating the MSIC in Kings Cross (MSIC Evaluation Committee, 2003) concluded that:

  • There were no changes in the number of heroin overdoses in the community.

  • The MSIC made referrals for drug treatment.

  • There was no increase in risk of blood-borne virus transmission.

  • There was no increase in crime.

  • The majority of the community accepted the presence of the MSIC.

A review study by Dolan et al. (2000) summarized the literature on SIFs in the Netherlands, Germany, and Switzerland. This review referenced studies showing a shift in public drug use and a general reduction in the visibility of the drug scene, as well as improved health of clients owing to contact with health and social services onsite and through referrals. Less evidence exists related to overdoses, although SIFs have reported no overdose deaths. Similarly, no studies have linked SIFs to HIV transmission, but reductions in risk behavior such as needle sharing and condom use have occurred among SIF clients.

Vending Machines

Syringe vending machines work like other types of vending machines, except that they accept contaminated syringes and dispense sterile syringes in exchange (Obadia et al., 1999). The Committee identified two studies from France and one study from Germany that examined the characteristics of users of such vending machines, and the machines’ usefulness in providing access to sterile syringes (Obadia et al., 1999; Moatti et al., 2001; Stark et al., 1994). One other study examined the feasibility of a pilot syringe vending machine project in a prison in Germany (Heinemann and Gross, 2001). All these studies showed that IDUs will use vending machines as a source of sterile needles and syringes, when available. None of these studies examine the effect of syringe vending machines on HIV-related risk behavior.

Obadia et al. (1999) collected questionnaires from 343 IDUs who ob-

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

tained their syringes from 32 pharmacies, 4 NSEs, and 3 vending machines in Marseille, France. Two-thirds (n=222) of respondents reporting the use of vending machines said that their main reasons were that syringes were free of charge and that the machines were available at all times. Primary users of vending machines (21.3 percent of the total sample) were younger and less likely to have been in drug treatment or to have engaged in HIV-related risk behavior in the past 6 months. This study concluded that despite the presence of other means of sterile needle and syringe access, vending machines attracted a regular portion of the IDU population that tended not to use the other services. There was no evidence that the vending machines were being abused. As compared to IDUs reporting predominant use of NSE or pharmacies for sterile needle and syringe access, duration of drug use did not last longer among IDUs reporting predominant use of vending machines (Obadia et al., 1999).

Based on the above evidence regarding pharmacy sales, physician-based prescriptions, supervised injecting facilities, and vending machines, the Committee concludes:

Conclusion 3-9: There is moderate evidence that the elimination of criminal penalties for possessing needles and syringes—and the enhancement of legal access via pharmacy sales, voucher schemes, and physician prescription programs—are alternative avenues for making sterile needles and syringes available to IDUs. Evaluations of these strategies have been conducted in the United States, and 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.


Conclusion 3-10: 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.

Recommendations for Sterile Needle and Syringe Access Programs

Recommendation 3-1: Given consistent evidence that multi-component HIV prevention programs that include sterile needle and syringe access reduce drug-related HIV risks, such programs should be implemented where feasible. Sterile needle and syringe access may include needle and syringe exchange or the legal, accessible, and economical sale of needles and syringes through pharma-

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

cies, voucher schemes, and physician prescription programs. Other components of multi-component HIV prevention programs may include outreach, education in risk reduction, HIV voluntary counseling and testing, condom distribution, bleach distribution and education on needle disinfection, and referrals to substance-abuse treatment and other health and social services.


Recommendation 3-2: Multi-component HIV prevention programs that include sterile needle and syringe access should:

  • Maximize their accessibility to the largest number of IDUs by using multiple access points and methods of delivery.

  • Focus on reducing sex-related HIV risk behavior.

  • Actively refer IDUs to other services, such as substance abuse treatment, HIV voluntary counseling and testing and, if appropriate, antiretroviral treatment for HIV.

  • Focus additional efforts on preventing hepatitis C infection, such as by providing sterile cotton swabs, alcohol wipes for cleaning injection sites, sterile water, cookers, and other disinfection supplies.

  • Incorporate strong program and component evaluations, and where feasible, include comparison populations or regions.

DISINFECTION PROGRAMS

Research on disinfection of injecting equipment may entail either laboratory (efficacy) studies or field (effectiveness) studies. A previous review by the National Research Council and the Institute of Medicine, Preventing HIV Transmission: The Role of Sterile Needles and Bleach (NRC and IOM, 1995) discussed laboratory studies extensively. Several laboratory studies published since that report support the panel’s findings (Abdala et al., 1999, 2001; 2004; Contoreggi et al., 2000; Druce et al., 1995; Van Bueren et al., 1995; Weber et al., 1999). The next section briefly summarizes the report and the more recent lab studies, although these types of studies are difficult to compare because of differences in their protocols and experimental conditions. Because field studies of disinfection programs are more relevant to the charge of this Committee, the ensuing section discusses those studies more completely.

Laboratory Studies

A study by Newmeyer (1988) identified five essential features of disinfection techniques for IDUs. According to the author, the technique should: (1) be quick, preferably less than 60 seconds; (2) be inexpensive; (3) use

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
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materials conveniently available; (4) be safe for the user and the injection equipment; and (5) be effective in neutralizing viruses.

Several early studies examined different disinfectants, such as bleach, hydrogen peroxide, isopropyl alcohol, and common household products (Spire et al., 1984; Martin et al., 1985; Resnick et al., 1986). These studies found that bleach was the most feasible disinfectant because of its wide availability and low cost, and because accidental injection would not greatly harm drug users (Froner et al., 1987). A bleach solution loses potency over time, and more quickly when exposed to sunlight, oxygen, and heat (NRC and IOM, 1995). Contact time, volume of blood, and the presence of other matter, such as clotted blood in syringes, also affect efficacy. Although the optimal exposure time for inactivating HIV is 30 seconds, laboratory studies have found that variations on this amount of time are acceptable.

Shapshak and colleagues (1994) obtained blood from HIV-1 infected IDUs, to test the effectiveness of bleach as a disinfectant for needles and syringes. Results showed that undiluted household bleach can inactivate HIV-1 in both clotted and unclotted blood—allowed to stand at room temperature for different periods, including 3, 6, 18, and 24 hours—after an exposure time of 30 seconds. Ten percent bleach did not inactivate HIV-1 in clotted blood after an exposure time of 30 seconds, and undiluted bleach was not effective at an exposure time of 15 seconds. However, critics assert that the volume of blood in the syringes was greater than would normally occur.

Druce et al. (1995) similarly found that when contaminated syringes were allowed to stand at room temperature for 3 hours, undiluted bleach inactivated or removed cell-associated HIV after 30 seconds. Another study by Newmeyer et al. (1990) found that undiluted bleach eradicated cell-free HIV after an exposure time of 60 seconds.

More recently, in 2001, Abdala and colleagues simulated common drug injection practices, to prepare syringes for a study. Of unrinsed syringes stored for about 1 day, 86 percent yielded viable HIV-1, with the volume of blood in the syringe affecting the outcomes. Rinsing the syringes once with water significantly lowered recovery of HIV-1, and rinsing them more often decreased recovery even more. Rinsing the syringes once with 10 percent diluted bleach also significantly reduced recovery—equivalent to a single rinse with water. Of 153 syringes rinsed with undiluted bleach, in contrast, HIV-1 was recovered from only 1. (Contact time for all rinses was about 5 seconds.)

Contoreggi et al. (2000) showed that high concentrations of bleach inhibit in-vitro replication of HIV-1 and reduce the viability of target cells. Lower concentrations of bleach in the cell-culture medium did not reduce the viability of target cells, and appeared to allow HIV-1 infection and replication.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

Studies have also examined the efficacy of other common disinfectants. Flynn et al. (1994) found that liquid dish detergent and rubbing alcohol may be viable alternatives when bleach is not available. However, the study performed only a small number of repetitions, and Abdala et al. (2004) found that dish detergent does not fully disinfect syringes. Improperly stored bleach—stored at 37°C and exposed to light—and rubbing alcohol performed better than water and other liquids but worse than properly stored 10 percent bleach.

Bleach does fade the numbers on the syringe barrel that indicate dose levels, and could corrode rubber inside the syringe (Newmeyer, 1988). Flynn et al. (1994) found that relatively few rinses of undiluted bleach can damage syringes. Morgan (1992) reported a case of a 31-year-old man who injected less than 1 milliliter of bleach and then experienced transient left-sided chest pain and vomiting, but no serious complications.

Based on this evidence, the Committee concludes:

Conclusion 3-11: Strong evidence from laboratory studies shows that undiluted bleach can inactivate HIV in injecting equipment, and is more efficacious than other tested disinfectants. Storage conditions, contact time, volume of blood, and the presence of other matter influence the efficacy of bleach as a disinfectant.

Field Studies

Although laboratory studies show that undiluted bleach inactivates HIV after an exposure time of 30 seconds, the evidence supporting the effectiveness of bleach disinfection in the field is weak. The Centers for Disease Control and Prevention endorses a procedure for using bleach to cleanse injecting equipment (see Box 3.2). Despite wide agreement on this technique, it is unclear what research, if any, has been performed to examine alternative options for effective bleach disinfection that would be simpler or more acceptable to IDUs. Later in this chapter, the Committee calls for more research on developing simple and effective disinfection techniques as well as strategies for increasing the uptake of these techniques. The Committee did not identify any studies examining the effectiveness of alternative disinfectants, despite the fact that bleach is not available or acceptable in certain settings.

Four studies have shown that IDUs fail to comply with the recommended procedures. McCoy and colleagues (1994) evaluated the recall and performance of a common bleach disinfection procedure. This entails completely filling the syringe with bleach twice, and then filling the syringe completely with water twice, without returning the used bleach or water to the source containers. During follow-up 6 to 12 months after IDUs (n=450)

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

BOX 3-2

Instructions for Disinfecting Syringes

  • Fill the syringe with clean water and shake or tap.

  • Squirt out the water and throw it away. Repeat until there is no visible blood in the syringe.

  • Completely fill the syringe with fresh, full-strength household bleach.

  • Keep it in the syringe for 30 seconds or more.

  • Squirt it out and throw the bleach away.

  • Fill the syringe with clean water and shake or tap.

  • Squirt out the water and throw it away.

SOURCE: CDC (2004).

were taught the procedure, more than 90 percent performed the basic steps. However, only 43.1 percent completely filled the syringe with bleach, and only 35.8 percent did so at least twice.

Gleghorn and colleagues (1994) measured syringe-cleaning strategies among IDUs in Baltimore by interviewing them and videotaping a demonstration of their most recent injection. Of the 146 IDUs who reported cleaning their needles, 85 (58 percent) used full-strength household bleach. Of the IDUs who did not use full-strength bleach, 90 percent used water alone. Eighty percent of the 85 bleach users recorded a total contact time of less than 30 seconds, and only 30.6 percent filled the syringe at least half-way. The authors noted that the median contact time per flush was approximately 10 seconds, indicating that drug users might achieve the minimum contact time of 30 seconds if they were encouraged to perform at least three flushes.

Carlson et al. (1998) compared baseline needle-cleaning practices with those after an intervention, with follow-up occurring 2 to 4 weeks and 6 months later. Mean exposure time rose from 13.8 seconds at baseline (n=541) to 21.1 seconds at 6-month follow-up (t=2.98; p<0.05). Only 30.3 percent of IDUs kept bleach in the syringe for at least 30 seconds at the 6-month follow-up.

In 1987, Chaisson et al. evaluated a program in San Francisco in which outreach workers distributed vials of 5.25 percent sodium hypochlorite (bleach) and instructions on sterilizing equipment. The study compared rates of needle and syringe disinfection in 1985 with those in 1987, one year after the program began. In both years, 71 percent of subjects reported sharing needles. In 1987, (n=172), 47 percent of sharers reported that they usually or always used bleach to clean their equipment, compared with only 6 percent who reported doing so in 1985 (n=152). The prevalence of HIV

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

among IDUs in treatment also rose, from 10 percent in 1985 to 15 percent in 1987.

Effect on HIV Seroconversion

Three nested case-control studies have examined the impact of reported bleach use on HIV seroconversion among IDUs. These studies found that bleach use offered little protection against HIV infection. In Baltimore, Vlahov et al. (1991) compared 22 black heterosexual HIV seroconverters with 95 persistent HIV-seronegatives matched on gender, use of cocaine, date of entry into the study, and duration of follow-up. The study found that bleach use had a limited protective effect on HIV seroconversion. The odds ratio for seroconversion among IDUs reporting disinfection all the time was 0.77, compared with an odds ratio of 0.91 among those reporting disinfection some of the time. Shooting gallery users reporting frequent use of disinfectant had an odds ratio of seroconversion of 0.63. In a similar study, Vlahov et al. (1994) found that IDUs reporting the use of disinfectant all the time had an odds ratio of seroconversion of 0.87 (95% CI: 0.32–2.37), compared with those reporting no use of disinfectants.

A nested case-control study by Titus et al. (1994) evaluated the efficacy of bleach disinfection of needles and syringes among IDUs in preventing HIV infection. Cases included 16 HIV seroconverters who reported injecting with shared or used equipment in the 6 months before their first HIV-seropositive visit. Controls included 89 HIV-negative IDUs who reported injecting with shared or used equipment, and who were seen within 6 months of the seroconversion of the index case. Risk factors (based on univariate analyses) included a history of sexual intercourse with an HIV-seropositive partner, and frequency of speedball injection (mixed heroin and cocaine). Bleach use was not associated with a decreasing odds for HIV seroconversion. In multiple logistic regression analysis, the frequency of bleach use was not significant (likelihood ration p-value=0.07) after adjusting for sex with an HIV-seropositive partner, speedball injection frequency, frequent recall, and gender.

Because HCV is more easily transmitted than HIV, strict compliance with disinfection procedures is even more important. In a nested case-control study, Kapadia et al. 2002 examined whether disinfection with bleach protects people from hepatitis C virus seroconversion. Participants who reported using bleach all the time had an odds ratio for HCV seroconversion of 0.35 (95% CI: 0.08–1.62), while those reporting bleach use some of the time had an odds ratio of 0.76 (95% CI: 0.21–2.70), compared with those reporting no bleach use.

These studies suggest that while bleach and other disinfectants are

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

efficacious in eradicating HIV in injecting equipment in controlled laboratory settings, the effectiveness of disinfection programs is not convincing in uncontrolled field settings. This may be due partly to inadequate education on proper cleaning techniques or their inherent complexity and time-consuming nature. As discussed in Chapter 1, injecting drug users can follow a hierarchy of steps to reduce their HIV risk. The best approach is to stop using drugs. If a drug user is unable to stop using or injecting drugs, the use of new injecting equipment for each injection will help prevent HIV transmission. Disinfecting used equipment with bleach is an option when new equipment is not available, because that procedure can decontaminate needles and syringes if done properly.

Conclusions and Recommendation for Disinfection Programs

Conclusion 3-12: If used according to the guidelines of the Centers for Disease Control and Prevention, the National Institute on Drug Abuse, and the Center for Substance Abuse Treatment, there is strong evidence that undiluted bleach can be an effective HIV prevention strategy for injecting drug users who share needles and syringes.


Conclusion 3-13: Strong evidence from field studies shows that, in practice, IDUs do not correctly use bleach, and that they fail to properly disinfect syringes.


Recommendation 3-3: Because field studies have shown that drug users often fail to properly disinfect injecting equipment, concerted effort should be made to increase the uptake of effective procedures for disinfecting shared equipment. IDUs should rely on disinfection to prevent HIV and HCV infection only when they cannot stop injecting or do not have access to new, sterile injecting equipment. Undiluted bleach is the most effective disinfectant. However, in some settings, bleach may not be available or acceptable for disinfecting injection equipment, and IDUs may use or need alternative disinfectants.

OUTREACH AND EDUCATION

To evaluate the effectiveness of outreach programs in preventing HIV infection, the Committee considered studies identified by its literature review (see Appendix B). This analysis focused on the effect of outreach on (1) drug-related risk behavior; (2) sex-related risk behavior; (3) HIV incidence; and (4) links with care.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

Drug-Related Risk Behavior

Evidence associates outreach with reductions in drug-related risk. In 1998, a review of published outcome data regarding outreach-based HIV prevention efforts concluded that they have been effective in reaching out-of-treatment IDUs and spurring behavioral change (Coyle et al., 1998). That review examined 36 studies, most of which were observational or quasi-experimental and were derived from research supported by the National Institute of Drug Abuse (NIDA) of the United States. Nineteen of the 36 studies were evaluations of interventions from the National AIDS Demonstration Research Program (NADR), which began at NIDA in 1987 and was designed to facilitate the implementation of HIV prevention outreach and intervention initiatives throughout the United States (Coyle et al., 1998). Projects were focused on reaching out-of-treatment drug users and their sexual partners, and employed former drug users and other community members to recruit and retain people in the intervention programs (Coyle et al., 1998). Twelve of the 36 studies were evaluations from interventions of the successor of NADR, the Cooperative Agreement for AIDS Community-Based Outreach/Intervention Research (Coyle et al., 1998).

Outreach activities through NADR included basic risk reduction activities such as literature on HIV prevention and services, distribution of condoms and bleach kits, and referrals to services including drug treatment (Coyle et al., 1998). Enhanced outreach interventions also included HIV testing and counseling and bleach and condom demonstrations. Study participants were often randomly assigned to either basic outreach services or basic outreach plus enhanced outreach services. In the Cooperative Agreement studies, interventions were standard across all sites. Outreach was conducted a maximum of five times and provided HIV education and service referrals, and condom and bleach distribution. HIV testing and counseling was a standard follow-up activity that included demonstrations of condom and bleach use. The education sessions promoted messages that covered the hierarchy of risk reduction (stop using drugs; stop reusing injecting equipment; disinfect reused injecting equipment) (Coyle et al., 1998).

The studies consistently reported that after an outreach intervention, significant declines occurred in self-reported injection drug use (10 of 11 studies), injection frequency (17 of 18 studies), reuse of needles and syringes (16 of 20 studies), and reuse of other equipment such as cookers, cotton, and rinse water (8 of 12 studies) (Coyle et al., 1998). The studies also showed significant effects in protective behaviors such as more frequent disinfection of needles, entry into drug treatment, and increases in condom use. Although the studies in this review did not have control groups, most studies of NADR and Cooperative Agreement interventions were

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

based on pre-test and post-test designs of a specific group. The comparison of behaviors at baseline to those at follow-up established a time sequence between intervention and outcome. In addition, the observed effects of the interventions were similar across evaluations more often than not (Coyle et al., 1998). To corroborate the self-reports of drug-related risk behavior, NADR and Cooperative Agreement investigators used urinalysis and visual examination of recent needle injection. There were no tools available to corroborate reports of sex-related risks (Coyle et al., 1998).

A later review article by Needle and colleagues (2005) updated the 1998 review and confirmed findings that outreach results in self-reported reduction in HIV-related risk behavior. This review lays out the origins and evolution of community-based outreach models starting from the early 1980s when outreach was characterized by repeated and time-intensive contact with IDUs by “insiders” to the IDU population. In the 1990s, peer-driven models were designed to focus on IDU networks as a method to reduce individual IDU risk. Many recent outreach models rely on recruiting people from IDU concentrated areas and encouraging them to use their residences for services and to provide the means for behavior change. Outreach services are also linked to voluntary testing and counseling and HIV treatment services. This review reported its findings in relations to three questions: (1) Is outreach an effective strategy for reaching hard to reach, hidden IDU populations and providing the means for changing behavior? (2) Do a significant proportion of IDUs receiving outreach-based interventions reduce their HIV risk behaviors—drug using, injecting equipment use, and sexual—and adopt safer behaviors? (3) Are changes in behaviors associated with lower rates of HIV infection among IDUs? The review concluded that evidence from more than 40 studies indicate that community-based outreach reaches hidden populations and provides the means for behavior change among IDUs, including reduction of drug use, reduction of syringe and other equipment sharing, and if referrals are available, increased use of drug dependence treatment and voluntary counseling and testing.

Discerning which intervention component is responsible for which outcome is often difficult, especially when individual programs include numerous interventions that occur simultaneously. A study by Colon (1995) in Puerto Rico showed that secular trends unrelated to the direct effects of outreach accounted for a significant reduction in reported risk. However, later trends in sharing of cookers and bleaching of needles showed shifts that the secular trends could not account for. The authors concluded that the outreach exerted a significant but partial effect on behavioral risk associated with drug injection, and had no effect on sexual risk behavior. A study by Neaigus et al. (1990) of the AIDS Outreach Project in New York

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

City—which provided information and anonymous HIV testing to street-recruited IDUs—also found that external trends could not account for reductions in risk.

Sex-Related Risk Behavior

Evidence that outreach exerts a positive impact on sex-related HIV risk behavior among IDUs is less substantial. Most outreach focuses on limiting drug-related risk, despite the fact that sexual risk behavior among IDUs raises the odds that they will transmit HIV to the general population (Semaan et al., 2002). A review by Coyle et al. (1998) found that 16 of 17 studies showed an increase in self-reported condom use or a decrease in self-reported unprotected sex after outreach. The authors note, however, that a large percentage of IDUs continued to practice high-risk sexual behavior. The review by Needle et al. (2005) showed that outreach can increase condom use, but that as compared to drug-related risk, smaller changes were seen in sexual risk reduction.

Another review by Empelen et al. (2003) focused mostly on psychosocial interventions, but did examine three studies of outreach and community-level interventions. Two (Jamner et al., 1997; Rietmeijer et al., 1996) of these three studies found changes in sexual behavior—such as self-reported condom use and number of sex partners—among participants in an intervention, compared with control groups, while one study did not find any risk reduction (Collins et al., 1999).

A meta-analysis by Semaan et al. (2002) showed that some interventions have lowered sexual risk among IDUs, including outreach based on multiple theories and strategies, peer interventions, and skills training. A study of network-oriented peer outreach suggests that interventions with an emphasis on social roles and identity can reduce injection risk behavior and increase condom use with casual sex partners (Latkin et al., 2003).

Effects on HIV Incidence

The Committee found one study that directly examined the impact of outreach on HIV incidence. In a prospective cohort study, Wiebel (1996) monitored trends in HIV risk behavior and seroconversion among IDUs receiving street-based outreach in Chicago from 1988 to 1992. The study found that HIV seroconversion fell from 8.4 to 2.4 per 100 person-years. Drug-related risk behavior also declined from 54 percent at baseline to 14 percent in the final year of follow-up. Seroconversion was associated with injection risk behavior (RR=9.8).

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

Outreach and Education in High-Risk Countries

While there are many studies that provide descriptions of outreach and education activities in high-risk countries (see Box 3.3 for an example), the Committee identified only three studies examining the effectiveness of outreach and education as HIV prevention for IDUs. A study by Peak et al. (1995) in Kathmandu, Nepal, measured changes in self-reported HIV risk behavior and HIV seroprevalence among IDU clients of a comprehensive outreach program from 1991 to 1994. The program distributed clean injecting equipment, condoms, and bleach, and provided education, counseling, and primary health care. Results showed that indictors of unsafe injecting fell and knowledge of HIV rose, while indicators of unsafe sex did not change. HIV seroprevalence remained low, at 1.6 percent in 1991 and 0

BOX 3-3

An Example of Outreach in India

Churachandpur is a small town in the northeastern state of Manipur that is currently home to about 600 to 800 IDUs. The town’s six drug treatment centers offer abstinence-based spiritual and 12-step programs.

Leaders of an outreach project believed that before it could begin, they needed buy-in from the community, including law enforcement and religious leaders. Toward that end, project leaders created an advisory committee chaired by the local police commissioner. Police support for the program increased, and outreach workers were not harassed once the project began. Project leaders also met with religious leaders and gave them factual information on HIV/AIDS. Although the attitude of the religious leaders toward drug users did not change, they did appreciate the importance of the outreach intervention in preventing HIV and supported it. Project leaders also built awareness of HIV/AIDS among families and friends of IDUs, local nongovernmental organizations, and health professionals.

Outreach workers were chosen to represent the town’s many ethnic groups, and the majority had a history of injecting drug use. These workers were trained in the basic facts of HIV, the importance of preventing transmission among IDUs and their partners, how to deliver prevention messages, when and where to refer IDUs for drug treatment, and safety and security.

Outreach workers were assigned to areas identified as gathering places for IDUs. On first contact with IDUs, workers explained the project, while at later meetings they presented prevention messages and distributed kits, including bleach (and instructions for use), cookers, clean water, cotton, and condoms. Within a year, the project had distributed about 4,000 kits and reached some 750 IDUs. Outreach workers also provided referrals for medical services and drug treatment, although the area lacked health care services generally, and the closest HIV voluntary counseling and treatment center was 60 kilometers away.


SOURCE: Hangzo et al. (1997).

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

percent in 1994. Later studies found that HIV prevalence among IDUs in Kathmandu grew rapidly, from 0 percent in 1995 to 40 percent in 1997, and to 68 percent in 2002 (Oelrichs, 2000; UN Nepal Information Platform, 2005).

Chen and Liao (2005) considered a culture-based model that places health education in the context of Chinese ethics. Pre- and post-test data from a pilot study showed that such a program among female IDUs (n=100) increased knowledge of HIV/AIDS, increased condom use, and decreased needle and syringe sharing. Kumar et al. (1998) examined the effectiveness of community-based outreach in reducing risk behavior for HIV transmission in two locations in Madras, India. Frequency of needle use and sharing declined significantly (p=0.01) among IDUs at outreach locations, compared with IDUs at control locations with no outreach services. Approximately 30 percent of IDUs from outreach locations always cleaned syringes and needles before use, compared with 10.3 percent of control IDUs. The two groups did not differ significantly in their sexual risk behavior.

Links to Health and Social Services

One study showed that outreach increases drug users’ entry into treatment programs (Rowden, 1999). Participants were recruited from 1 of 12 HIV Outreach Demonstration Projects funded by the U.S. Center for Substance Abuse Treatment. Clients from hard-to-reach groups were more likely to enter treatment for substance abuse through outreach programs than through treatment-specific recruiting. Outreach was particularly effective in reaching drug users earlier in the cycle of abuse. A review by Coyle et al. (1998) reported that six of seven studies found that outreach participants entered drug treatment. The review by Needle et al. (2005) points out that recent data from a multi-site (12 cities) study from 1995–2000 in the United States shows that of IDUs reached by the outreach intervention, 68 percent were referred to drug treatment of whom 41 percent entered treatment.

Conclusions and Recommendations on Outreach

Conclusion 3-14: Modest evidence from several studies and reviews from developed countries—most with weak study designs—shows a degree of consistency in finding that outreach and education reduces self-reported drug-related risk behavior. There is limited evidence that outreach can reduce self-reported sex-related HIV risk behavior.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

Conclusion 3-15: There is moderate evidence that outreach is an effective strategy for providing education on preventing HIV transmission, and referrals to services, for hard-to-reach populations of IDUs.


Recommendation 3-4: Outreach services should be made available to provide education on risk reduction and links to sterile needle and syringe access programs, drug treatment, and medical and social services for hard-to-reach IDUs.

FUTURE RESEARCH

The Committee identified several gaps in the evidence base for policymaking and program building. First, there is limited evidence on the impact of sterile needle and syringe access and outreach and education on reducing sexual risk. Additional research is needed to identify the most effective sexual risk reduction strategies for IDUs, and to determine how to successfully integrate these strategies into multi-component programs and outreach and education.

Second, few studies have specifically evaluated whether HIV prevention programs that include needle and syringe exchange lead to unintended consequences such as increases in new drug users, expanded networks of high-risk users, more discarded needles in the community, and changes in crime trends. Future research should specifically evaluate these unintended outcomes, and—if found—develop strategies for addressing them.

In addition, while laboratory studies have shown that undiluted bleach is an effective disinfection agent, field studies show that IDUs often fail to properly use bleach to disinfect equipment, thereby putting them at risk for acquiring HIV. More research is needed on alternative bleach disinfection techniques that are both simple and acceptable, and on the best methods for educating IDUs on those techniques. The Committee is also aware that in some countries, bleach is not available or acceptable for use. While alternative disinfectants have been examined in laboratory settings, the Committee did not identify any studies that examine the effectiveness of alternative disinfectants (e.g., water, alcohol, hydrogen peroxide, detergent) in field settings, and calls for more research in this area.

Furthermore, in light of the persistently high incidence of HCV among NSE participants, more research is also needed on the impact of NSE and related prevention services on the incidence of hepatitis C among IDUs. Such research should particularly focus on new injectors, and assess whether enhanced programs that provide specific information on reducing HCV risk—and that provide other clean materials such as alcohol swabs, sterile cotton, and water—reduce the incidence of HCV.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

Finally, studies show that multi-component prevention programs that include needle and syringe exchange are associated with reductions in drug-related HIV risk behavior. The Committee believes that multi-component programs that include NSE are likely to add value to a national HIV prevention program, but that existing research does not allow us to disentangle the specific contribution of each component. The individual components probably have different levels of effectiveness, and they may interact in ways that are not fully understood. A full understanding of each intervention component may highlight those that do not add substantial value in the presence of other interventions, and that are associated with unanticipated effects. In some cases the effects may be synergistic. This issue is important from a policy perspective because elements of these multi-component prevention programs can be resource intensive.

Further research is needed to help identify the most effective and cost-effective combination of programs that is feasible for high-risk countries. While these questions could be addressed in several ways, a community randomized trial would be the most rigorous approach (see Box 3.4 for an explanation of community randomized trials). Because of the complex nature of community randomized trials, the Committee provides an overview of potential trial design and implementation challenges in Appendix E. While the call for further research may seem to contradict the advice to launch multi-component programs that include NSE now, that call reflects a balance between the urgent need to prevent HIV infection and the responsibility to do so in the most ethical, effective, and cost-effective manner possible. Imperfect knowledge is not a defense against inaction in this case, and the wait for the results of further research should not hinder the implementation of multi-component approaches, however incompletely understood.

Recommendation 3-5: The Committee recommends that additional research focus on:

  • The impact of outreach and education and multi-component programs that include sterile needle and syringe access on sexual risk reduction.

  • Integration of effective strategies for reducing sexual risk behavior and sexual transmission of HIV into multi-component programs that include sterile needle and syringe exchange and outreach and education.

  • The potential unintended consequences of HIV prevention programs that include needle and syringe exchange, such as increases in new drug users or in discarded needles in the community, and strategies to address such problems, if they are found.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

BOX 3-4

Community Randomized Trials

In a community randomized trial, some communities receive certain added interventions while other communities awaiting such interventions serve as comparison sites (often called “controls”). A stepped-wedge design would be most appropriate for a community randomized trial of multi-component HIV prevention programs. This design involves sequential rollout of an intervention (whereby intervention components are added to a standard package) in participating communities over time. Areas that are yet to receive a specific intervention serve as controls for the intervention area(s). This design is particularly relevant where an intervention may do more good than harm (making a factorial design, in which certain participants do not receive the intervention, unethical). Such a design is also appropriate where, for logistical, practical, or financial reasons, a program cannot simultaneously deliver an intervention to all participants (Gambia Hepatitis Study Group, 1987).

A “no treatment” or “minimal treatment” control arm would be inappropriate. Instead, control communities should have a substantial prevention program equaling or exceeding that already available. For example, in evaluating the effectiveness of a needle and syringe exchange component, investigators might provide a basic package of services, such as voluntary HIV counseling and testing to promote behavioral change, education on needle disinfection, and referrals to health services and drug treatment in both the control and experimental communities. Needle and syringe exchange could then be added in the experimental communities as part of a sequential rollout across all trial sites.

A community randomized trial makes particular sense for injecting drug users because they may share the same drug-using network and compare their treatment experiences. Thus randomizing participants on an individual basis could create situations where the control group could not be insulated from the intervention group, potentially contaminating the control regimen and blunting the study’s ability to detect important differences.

A community randomized trial could measure actual HIV incidence as a primary outcome. The trial would also represent an opportunity to evaluate the impact of multi-component prevention programs on HCV transmission. Secondary outcomes might include subjective and objective measures of risk behavior, including drug-related behavior (such as self-reports of needle sharing and needle disinfection) and sexual behavior (such as self-reports of condom use). Secondary outcomes might also include potential harm at the individual and community level (such as an increase in discarded needles or recruitment of new users). The study could also collect data on program costs and cost-effectiveness, to inform decisions on how best to allocate resources. A formative evaluation component could shed light on the best strategies for implementing the prevention program. See Appendix E for more detail on design and implementation issues related to community randomized trials.

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×
  • Identifying the simplest, most acceptable effective disinfection techniques using bleach, and the best methods for educating IDUs on these techniques.

  • The effectiveness of alternative disinfectants in field settings, particularly in countries where bleach is not available or acceptable.

  • Identifying effective strategies for preventing HCV among IDUs.

  • The costs and contributions of individual elements of multi-component programs that include needle and syringe exchange on HIV-related risk behavior and HIV incidence (see Box 3.4 and Appendix E).

CONCLUSION

For injecting drug users who cannot gain access to treatment or are not ready to consider it, multi-component HIV prevention programs that include sterile needle and syringe access reduce drug-related HIV risk behavior such as self-reported sharing of needles and syringes, unsafe injecting and disposal practices, and frequency of injection. Avenues of sterile needle and syringe access may include needle and syringe exchange; the legal sale of needles and syringes through pharmacies, voucher schemes, physician prescription programs, and vending machines; or supervised injecting facilities. Needle and syringe access is often part of a multi-component HIV prevention program. Other elements of multi-component programs may include outreach, education in risk reduction, HIV voluntary counseling and testing, condom distribution, bleach distribution and education on needle disinfection, and referrals to substance abuse treatment and other health and social services.

Participation in multi-component HIV prevention programs that include needle and syringe exchange is associated with a reduction in self-reported drug-related HIV risk behavior among IDUs. Such behavior includes self-reported sharing of needles and syringes, safer injecting and disposal practices, and frequency of injection. Sterile needle and syringe access is not primarily designed to address sex-related risk behavior, and this issue has not been well studied. The existing evidence is insufficient to determine the effectiveness of programs that include needle and syringe access in reducing sex-related risk. The Committee calls for more research to determine the impact of such programs on sex-related risk, and on integrating effective strategies for reducing sexual risk behavior and sexual transmission of HIV into multi-component programs that include sterile needle and syringe access.

The evaluation of strategies to eliminate criminal penalties for possess-

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

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

Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
×

and methods of delivery, focus on reducing sexual risks, actively refer drug users to other services, focus additional efforts on preventing hepatitis C, and incorporate strong program and component evaluations.

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Suggested Citation:"3 Sterile Needle and Syringe Access and Outreach and Education." Institute of Medicine. 2007. Preventing HIV Infection Among Injecting Drug Users in High-Risk Countries: An Assessment of the Evidence. Washington, DC: The National Academies Press. doi: 10.17226/11731.
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Drug dependence is a complex, chronic, relapsing condition that is often accompanied by severe health, psychological, economic, legal, and social consequences. Injecting drug users are particularly vulnerable to HIV and other bloodborne infections (such as hepatitis C) as a result of sharing contaminated injecting equipment. All drug-dependent individuals, including injecting drug users (IDUs), may be at increased risk of HIV infection because of high-risk sexual behaviors. There are an estimated 13.2 million injecting drug users (IDUs) world-wide—78 percent of whom live in developing or transitional countries. The sharing of contaminated injecting equipment has become a major driving force of the global AIDS epidemic and is the primary mode of HIV transmission in many countries. In some cases, epidemics initially fueled by the sharing of contaminated injecting equipment are spreading through sexual transmission from IDUs to non-injecting populations, and through perinatal transmission to newborns. Reversing the rise of HIV infections among IDUs has thus become an urgent global public health challenge—one that remains largely unmet.

In response to this challenge, the Institute of Medicine convened a public workshop in Geneva in December 2005 to gather information from experts on IDU-driven HIV epidemics in the most affected regions of the world with an emphasis on countries throughout Eastern Europe, the Commonwealth of Independent States, and significant parts of Asia. Experts from other regions also provided information on their experiences in preventing HIV infection among IDUs. This report provides a summary of the workshop discussions.

Preventing HIV Infection among Injecting Drug Users in High Risk Countries describes the evidence on the intermediate outcomes of drug-related risk and sex-related risk prior to examining the impact on HIV transmission. This report focuses on programs that are designed to prevent the transmission of HIV among injecting drug users. These programs range from efforts to curtail non-medical drug use to those that encourage reduction in high-risk behavior among drug users. Although the report focuses on HIV prevention for IDUs in high-risk countries, the Committee considered evidence from countries around the world. The findings and recommendations of this report are also applicable to countries where injecting drug use is not the primary driver, but in which injection drug use is nevertheless associated with significant HIV transmission.

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