FACTORS ASSOCIATED WITH METHOD OF SYRINGE ACQUISTION AMONG INJECTION DRUG USERS IN SAN DIEGO. A Thesis. Presented to the.

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1 FACTORS ASSOCIATED WITH METHOD OF SYRINGE ACQUISTION AMONG INJECTION DRUG USERS IN SAN DIEGO A Thesis Presented to the Faculty of San Diego State University In Partial Fulfillment of the Requirements for the Degree Master of Public Health by Katherine A. Banares Spring 2011

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3 iii Copyright 2011 by Katherine A. Banares All Rights Reserved

4 iv ABSTRACT OF THE THESIS Factors Associated with Method of Syringe Acquisition among Injection Drug Users in San Diego by Katherine A. Banares Master of Public Health San Diego State University, 2011 Procurement of sterile needles is an important intervention for reducing the transmission of blood-borne pathogens among injection drug users (IDUs). In San Diego, a syringe exchange program (SEP) is available; however accessibility to other safe syringe sources is limited because nonprescription sales of sterile syringes remains illegal. The aims of this study were to (1) estimate the proportion of IDUs in San Diego who are accessing SEP, other safe sources, or unsafe sources as their primary source for needles and (2) identify sociodemographic characteristics, injection practices, and other behaviors correlated with each of these primary syringe sources. From 2009 to 2010, a cross-sectional survey was administered to current drug injectors recruited through the SEP, street outreach, and recruitment driven sampling in San Diego, California. Data were collected with audio-computer assisted interview (ACASI) technology. Polychotomous logistic regression was performed to identify differences in characteristics of IDUs in San Diego primarily accessing the SEP, other safe, and unsafe syringe sources. Of 566 eligible individuals who completed the participant questionnaire, 529 provided information on their primary syringe source in the last three months; 58% reported unsafe sources, 29% reported SEP, and 13% reported other safe sources. After adjusting for recruitment method and other variables in the model, SEP users were more likely to inject everyday, use heroin (alone or with other drugs) as the drug they injected most frequently, inject with a new syringe at least half the time, report ease with obtaining new syringes, and ever been in drug treatment compared to IDUs who primarily used unsafe syringe sources. SEP users were also more likely to inject everyday compared to users of other safe syringe sources. The majority of IDUs in this study are still using unsafe sources to obtain syringes, suggesting the importance of improving sterile syringe access. Differences in injection practices by primary syringe source exist in IDU populations in San Diego. Interventions must tailor their programs and local policies must change to reflect these differences and to increase access to sterile syringes.

5 v TABLE OF CONTENTS PAGE ABSTRACT... iv LIST OF TABLES... vii LIST OF FIGURES... viii ACKNOWLEDGEMENTS... ix CHAPTER 1 INTRODUCTION...1 Background...1 Statement of the Problem...3 Purpose of the Study...3 Hypothesis...3 Definitions of Terms LITERATURE REVIEW...5 Epidemiology of the Injection drug Use...5 Infectious Diseases Related to Drug Abuse...7 Interventions and Prevention for IDUS: An Overview...9 Syringe Exchange Programs...11 SEP In San Diego, California...13 Pharmacies and Other Safe Syringe Sources...14 Unsafe Syringe Sources...17 Sociodemographics Associated with Syringe Sources...19 Injection Practices Associated with Syringe Sources...20 Other Behaviors Associated with Syringe Sources...21 Study Setting...22 Summary METHODS...24 Study Design...24 Data Collection...25

6 vi Study Population...25 Survey Variables...26 Data Analysis RESULTS DISCUSSION...44 REFERENCES...51

7 vii LIST OF TABLES PAGE Table 1. Sociodemographic Characteristics and Self-Reported Primary Syringe Source of STAHR Participants by Recruitment Method (N=566)...32 Table 2. Comparison of Sociodemographics of SEP Participants at Intake and by Recruitment and Self-Reported Use in STAHR...33 Table 3. Characteristics of Participants by Primary Syringe Source in the STAHR Study, (N=529)...34 Table 4.Univariate Analysis of Factors Associated with Primary Syringe Source in STAHR Study, (N=529)...39 Table 5. Polychotomous Logistic Regression Results Comparing 3 Primary Syringe Sources in STAHR Study, (N=483)...42 Table 6. Drug Injected Most Frequently by Primary Syringe Source in STAHR Study, (N=524)...43

8 viii LIST OF FIGURES PAGE Figure 1. Study population of STAHR by recruitment method....26

9 ix ACKNOWLEDGEMENTS I thank my committee members - Dr. Brodine, Dr. Alcaraz, Dr. Reed, and Dr. Garfein - for their guidance and support during the thesis process. I thank my friends for their encouragement. Finally, I thank my family for their love and support.

10 1 CHAPTER 1 INTRODUCTION BACKGROUND Injection drug use is a major risk factor for transmitting or acquiring blood-borne infectious diseases, accounting for the majority of Hepatitis C infections, and directly and indirectly accounting for 12% of estimated new HIV infections in 2009 in the U.S. (Centers for Disease Control and Prevention [CDC], 2009b; Williams, Bell, Kuhnert, & Alter, 2011). The most common way that blood-borne pathogens are passed among injection drug users (IDUs) is through multi-person syringe use (Des Jarlais, Friedman, & Stoneburner, 1988). Infected IDUs can then pass the virus by sexual transmission to their partner or by perinatal transmission to their children, with HIV being transmitted more efficiently by these nonparenteral routes than HCV (Nicolosi, Leite, Musicco, Molinari, & Lazzarin, 1992; Tibbs, 1995). For IDUs who cannot or will not stop injecting, the one-time use of sterile syringes for each injection is recommended (U.S. Public Health Service, 1997). For these reasons, procurement of adequate sterile needles is critical to curbing the spread of diseases among the IDU community and beyond. Since their use is for illicit purposes, IDUs access to sterile syringes is limited forcing them to rely on a variety of sources for new syringes. Syringe exchange programs (SEPs), pharmacies, and hospitals are some sources that are considered safe in the fields of medicine and public health (Bluthenthal et al., 2004). Other sources of syringes including friends, sex partners, drug dealers, and shooting galleries are considered unsafe because these are secondary distributions that do not ensure that the syringe is sterile (Gleghorn, Jones, Doherty, Celentano, & Vlahov, 1995; Golub et al., 2005). Because there is no uniform, national policy in the U.S. regarding access and provision of sterile syringes to IDUs, state and local governments are relied upon to establish health policies. This has led to variation in the accessibility and availability of sterile syringes which is evident in different laws and policies regarding drug paraphernalia possession, operating mechanisms of SEPs, and the provision for nonprescription sales of

11 2 syringes (NPSS) in pharmacies across cities. In California, Assembly Bill (AB) 136 was implemented in January 2000 which decriminalized needle exchange programs if the City or County Councils declared a local health emergency to address increases in infectious diseases due to syringe sharing. In 2005, California Senate Bill (SB) 1159 was also passed which allowed syringes to be sold without a prescription in pharmacies according to a twostep process: the County or City local health jurisdiction (LHJ) must first authorize a Disease Prevention Demonstration Project (DPDP), and pharmacies within that jurisdiction must then also opt in to register and participate in the program (CDPH, 2008b). Some cities in California now offer both a SEP and NPSS, such as in San Francisco and Los Angeles. San Diego has a SEP, although this has very limited distribution due to lack of adequate resources. The pharmacy sale of syringes in San Diego remains illegal, nevertheless pharmacists have some discretion in choosing whom to sell syringes, which may vary according to personal attitudes about drug use behavior and harm reduction programs (Reich et al., 2002b; Taussig, Junge, Burris, Jones, & Sterk, 2002). In light of these differences, understanding sociodemographic chracteristics and injection behaviors of the target population for both safe and unsafe syringe sources is important because it can help tailor intervention efforts and potentially provide support for the expansion of legal syringe access. Prior studies have characterized and compared the demographics and risk profiles of IDUs who primarily use pharmacies, SEPs, and unsafe sources.many of these studies were conducted in places where at least SEPs and NPSS in pharmacies were available for access to sterile syringes. However more research is needed to understand the profile of IDUs who are able to access syringes from other safe sources in locations where NPSS is illegal, such as in San Diego, California. San Diego County is a large metropolitan area that has a population of 3,095,313 (U.S. Census Bureau, 2010). Currently a mobile SEP that is available for a total of six hours each week provides syringes to IDUs in San Diego according to a one-for-one exchange policy, with a maximum number of 30 syringes that can be exchanged per visit. NPSS in pharmacies in San Diego is illegal and is it not known to what degree pharmacists are choosing to sell syringes to IDUs. Data from the Study to Assess Hepatitis C Risks (STAHR), a cross-sectional study conducted by the University of California San Diego, were used for this study. From May

12 to July 2010, injection drug users currently living in San Diego County and between the ages of were recruited through the SEP in San Diego, street outreach, and recruitment driven sampling. Five-hundred sixty-six eligible individuals were enrolled in the study, completed a questionnaire using audio computer-assisted self-interviews (ACASI), and had their blood drawn to test for HCV and HIV antibodies. Information gathered from study participants responses to the questionnaire were used in this present study. STATEMENT OF THE PROBLEM Most of the existing studies regarding risk profiles among injection drug users (IDUs) have looked at sociodemographic and injection behaviors of IDUs by their syringe source in places where SEPs and NPSS in pharmacies are available. More research is needed to describe the profile of IDUs in cities where a SEP is available but that have not yet legalized NPSS, such as in San Diego, California. PURPOSE OF THE STUDY The proposed objectives of this study are to (1) estimate the proportion of IDUs in the STAHR cohort who are accessing SEP, other safe sources, or unsafe sources as their primary source for needles and (2) identify sociodemographic characteristics, injection practices, and other behaviors correlated with their primary syringe source. Results from this study can define the size and scope of the problem of the use of unsafe syringe sources. Further understanding and identifying the sociodemographic characteristics and injection behaviors of the target population of each syringe source can provide input for more effective public health interventions. Results can also help identify IDUs who are still using unsafe sources as their primary source of syringes and improve intervention efforts in reaching out to this population. HYPOTHESIS IDUs who primarily obtain their syringes from the SEP are less likely to practice risky injection behaviors than IDUs who primarily obtain their syringes from unsafe sources or other safe sources after controlling for potential confounders. Risky injection behaviors include injecting with old syringes, sharing syringes, and sharing cookers, cotton, or rinse water.

13 DEFINITIONS OF TERMS 1. IDU: Injection Drug User In this study, a person who injects illicit drugs using a syringe. 2. SEP: Syringe Exchange Program A program that aims at encouraging IDUs to exchange used needles for new, sterile ones and at discouraging sharing of injection equipment to reduce the transmission of blood-borne infectious diseases. These programs may provide other services to participants, such as testing, counseling, and referrals for drug treatment and health care services (General Accounting Office, 1993). 3. HIV: Human Immunodeficiency Virus A virus that causes acquired immunodeficiency virus (AIDS) in humans, leading to impaired immune functions. The virus can be passed from person-to-person with contact with bodily fluids. 4. AIDS: Acquired Immune Deficiency Syndrome A disease of global immune dysfunction caused by HIV. It is defined by a CD4+ T-lymphocyte count less than 200 cells per microliter or the diagnosis of one of 23 AIDS-defining conditions. 5. HCV: Hepatitis C Virus A virus that causes Hepatitis C, an infectious disease that affects the liver. HCV is spread by blood-to-blood contact. 6. AB136: Assembly Bill 136 A California Assembly Bill that was implemented on January 1, This enabled City or County Councils within California to operate needle exchange programs if they declared a local health emergency in response to increases in rates of infectious disease acquisition due to syringe sharing. 7. SB1159: Senate Bill 1159 A California Senate Bill implemented on January 1, This enabled the pharmacies to sell up to ten syringes to an adult without a prescription according to a two-step process in which interested city and local county health jurisdictions first authorize a Disease Prevention Demonstration Project, and pharmacies within that jurisdiction must then also opt in to register and participate in the program. 8. LHJ: Local Health Jurisdiction A geographic region (typically a county) that defines the population covered by a public health agency. 9. NPSS:Non-Prescription Syringe Sales Refers to the ability to legally purchase syringes at pharmacies without a prescription. 10. STAHR: Study to Assess Hepatitis C Risks, a cross-sectional study conducted among current injection drug users in San Diego from 2009 to Data taken from STAHR is used in this present study. 11. RDS: Recruitment Driven Sampling A snowball sampling method useful in recruiting individuals of hidden populations. RDS participants in this study were selected to recruit up to three other people in his/her injection network to complete the survey. Note: The term syringe is used throughout this paper to refer to both syringes and needles. 4

14 5 CHAPTER 2 LITERATURE REVIEW Injection drug use is a behavior that places people at risk of transmitting and acquiring blood-borne diseases such as Hepatitis B, Hepatitis C, and HIV. Access to sterile syringes is an important public health intervention in curbing the spread of these diseases, however varying policies and regulations related to drug paraphernalia and syringe sales affects their availability to IDUs. This literature review will focus on the epidemiology of injection drug use and associated morbidities, different syringe sources for IDUs, factors that affect accessibility and availability of these sources, and prior studies that have defined characteristics of IDUs by syringe source. Each section will start with general background on the topic and then will provide more specific information about how it relates to IDUs in San Diego the target population of this study. EPIDEMIOLOGY OF THE INJECTION DRUG USE In 2002, it was estimated that the number of current IDUs aged 15 to 64 across 96 metropolitan areas in the U.S. ranged from 37 to 336 per 10,000 persons (mean 110.5, standard deviation 57.7) (Brady et al., 2008). In other words, there are about 1.9 million current IDUs in the U.S. (range million). In fact in 2007, the three countries with the largest estimated populations of IDUs were China, the U.S., and Russia nations with the first, third, and ninth largest populations respectively (Mathers et al., 2008). Certain trends exist in the demographics of IDUs in the U.S. According to data collected from the National Survey on Drug Use and Health from 2002 to 2005, IDUs who injected heroin, methamphetamine, cocaine, or other stimulants in the past year were twice as likely to be male than female (Substance Abuse and Mental Health Services Administration [SAMHSA], 2007), and three times more likely to be 18 to 24 year olds compared to individuals younger (12 to 17) or 35 and older. Injection rates were higher among Whites than Blacks, and the lowest rates were among Asians (SAMHSA, 2007).

15 6 There are also common risk behaviors among IDUs in the U.S. According to data collected in 23 U.S. metropolitan areas between 2005 and 2006 by The National HIV Behavioral Surveillance System, it was reported that 31.8% of IDUs shared syringes, which was most common among non-hispanic whites (40.2%) and individuals between the ages of 25 and 34 (38.6%). Sixty-three percent had unprotected vaginal sex, which was highest specifically among the age group, and 47% had more than one opposite-sex partner in the prior 12 months. Although the majority of IDUs surveyed had ever had an HIV test (72%) or HCV test (72%), only 27% had ever participated in any other type of a behavioral intervention (CDC, 2009a). Direct syringe sharing, or reusing a syringe that has been used by another IDU, can aid in the transmission of the virus from one person to another because blood is in contact with syringes. Infected IDUs can further pass HIV by sexual transmission to their partner or by perinatal transmission to their children (Des Jarlais et al., 1988; U.S. Public Health Service, 1997). Sexual and perinatal transmission of HCV also occurs, but at a much lower rate (Tibbs, 1995). Indirect syringe sharing, that is the sharing of drug preparation equipment, can also spread infectious diseases. Drug preparation equipment includes the cookers (e.g. caps, spoons, containers) and water that are used to dissolve drugs with a heat source. Cotton balls that are used as a filter to block particles from the needle can also be contaminated with blood and increase the risk of spreading the disease (Thorpe et al., 2002). Other risky injection practices include backloading using one syringe to mix drugs, measure a share of that drug solution, and then used to squirt this share into another IDU s syringe (Jose et al., 1993); and registering - the practice of drawing back on the plunger of the syringe after venous insertion to check that a vein has been found before injecting drug solution (Vlahov & Junge, 1998). Reusing and sharing syringes and drug preparation equipment play critical mediating roles in the transmission of infectious diseases among injection drug users. The methods that IDUs use to obtain their syringes whether it is either safe or unsafe is an important factor that needs to be considered when thinking about the transmission of disease.

16 7 INFECTIOUS DISEASES RELATED TO DRUG ABUSE Injection drug use is of public health concern because it can lead to both bacterial and viral infections (Ebright & Pieper, 2002; Schoener, Hopper, & Pierre, 2002). Bacterial infections related to injection drug use include abscesses, endocarditis, tetanus, sepsis, and wound botulism (Gordon & Lowy, 2005; Spijkerman, van Ameijden, Mientjes, Coutinho, & van den Hoek, 1996). Factors that increase the risk for acquiring bacterial infections include using unsterile injection equipment, not cleaning the skin prior to injection, and injecting subcutaneously or intramuscularly rather than intravenously (Murphy et al., 2001; Vlahov, Sullivan, Astemborski, & Nelson, 1992). Although some IDUs have attempted to treat these infections by themselves, others have sought care in a hospital emergency room for these preventable injection-related complications (Kerr et al., 2005). For IDUs who cannot stop injecting, it is recommended that they use sterile injection equipment and clean the injection site with alcohol swabs prior to needle puncture (Gershon, 1998). The transmission of viral infections, such as human immunodeficiency virus (HIV), is also of public health concern among IDUs. HIV, found and transmitted in blood, semen, vaginal fluid, and breast milk, is a disease with global immune dysfunction that results in increased vulnerability to both pathogenic and opportunistic infections (Kilmarx, 2008). The vast majority of untreated individuals will progress to Acquired Immune Deficiency Syndrome (AIDS), which is defined by a CD4+ T-lymphocyte count less than 200 cells per microliter or the diagnosis of one of 23 AIDS-defining conditions (CDC, 1993). Although treatment and prognosis for those diagnosed with HIV and AIDS have improved over the years, there is still no cure for AIDS and control of the infection requires combination antiretroviral therapy to halt disease progression (Lu & Chen, 2010). Because the risk of HIV transmission increases with a higher viral load (Gray et al., 2001; Quinn et al., 2000), highly active anti-retroviral therapy (HAART) can be used to greatly reduce the HIV viral load to undetectable levels and reduce the risk of transmission (Li et al., 1998; Perelson et al., 1997). However these medications do not completely eradicate the virus from the body, and it is important that persons using HAART still refrain from high-risk sexual and drug-related behaviors (Kravcik et al., 1998; Tun, Gange, Vlahov, Strathdee, & Celentano, 2004; Vlahov et al., 2001). Furthermore, there currently is not an effective vaccine against HIV; therefore, primary prevention measures are our best hope for curtailing the epidemic.

17 8 In 2009, IDUs accounted for 9% of new HIV infections in the U.S., and an additional 3% was due to men who have sex with men (MSM)/injection drug use (CDC, 2009b). Once HIV is introduced into a group of IDUs, these drug users can then become the dominant source of parenteral and heterosexual transmission of this disease within their geographic area (Des Jarlais et al., 1988). San Diego County has the third highest number of HIV cases in California after Los Angeles and San Francisco (California Department of Public Health [CDPH], 2008a). In San Diego, 4% of HIV infections among men were among IDU and 8% were among MSM/IDU. Among women, 23% was due to injection drug use and 8% was attributed to having sex with an IDU. Compared to the U.S., San Diego had a lower proportion of HIV cases due to injection drug use (4% versus 12%) (County of San Diego Health and Human Services Agency, 2009). With respect to AIDS, San Diego County has the third largest number of AIDS cases in California (County of San Diego Health and Human Services Agency, 2010). Minorities are disproportionately affected by the HIV/AIDS epidemic as the majority of AIDS cases in San Diego have been in persons of color since 2000, with the highest annual AIDS case rate in Blacks followed by Hispanics (County of San Diego Health and Human Services Agency, 2009). Among men in San Diego between 2004 and 2008, IDUs accounted for 8% and MSM/IDU accounted for 10% of AIDS cases. Among women, injection drug use accounted for 20% and sex with an IDU accounted for an additional 17% of cases (County of San Diego Health and Human Services Agency, 2009). Hepatitis however, particularly HCV, is commonly the first blood-borne virus that is acquired among IDUs, and it is estimated to be about 10 times more transmissible by needlestick than HIV (Sulkowski, Ray, & Thomas, 2002). HCV is the most common bloodborne infection in the U.S. with about 3.2 million persons nationwide who are chronically infected with it (Armstrong et al., 2006). Injection drug use is the primary way that HCV is transmitted because sharing contaminated syringes, needles, and drug preparation equipment exposes them to infected blood (Alter & Moyer, 1998; Hagan et al., 2001; Thorpe, et al., 2002). About 60% of HCV transmission in theu.s. is attributed to injection drug use, and less common modes of transmission include sexual activity, occupational exposure, hemodialysis, and perinatal transmission (Alter, 1999; Williams, 1999).

18 9 Those who newly acquire hepatitis infections have nonexistent or mild flu-like symptoms such as fatigue, jaundice, nausea, and malaise (Chen & Morgan, 2006). About 75-85% of people with acute HCV cannot clear the virus and become chronically infected, with chronic liver disease progressing slowly over years to more severe diseases like liver cancer and cirrhosis (Chen & Morgan, 2006; Hagan, Jarlais, Friedman, Purchase, & Alter, 1995; Kim, 2002). Furthermore, patients with chronic HCV can be at risk of health conditions worsening if they are co-infected with other viruses, including HIV, Hepatitis B Virus, and Hepatitis A Virus (Chen & Morgan, 2006; Vento et al., 1998). A vaccine for HCV infection has not yet been made, and unlike HIV, there is no effective prophylaxis for HCV perinatal transmission (Arshad, El-Kamary, & Jhaveri, 2011). Primary prevention of HCV infection is thus important. HCV is acquired relatively quickly among IDUs (Alter & Moyer, 1998) with an estimated 50-80% of IDUs developing Hepatitis C not long after initiating injection drug use (Garfein, Vlahov, Galai, Doherty, & Nelson, 1996; Hagan & Des Jarlais, 2000). Several factors influence this rapid uptake: viral factors, including the high efficiency of HCV transmission (Mitsui et al., 1992; Sulkowski, et al., 2002); a prolonged asymptomatic period in which infected individuals may unknowingly transmit the virus to others (McCaughan et al., 1992); and IDU-related behavioral factors, such as sharingdrug paraphernalia and syringes and unsafe injection practices (Hagan et al., 2001; Thorpe et al., 2002). Treating bacterial and viral infections is particularly challenging among IDUs. This population is associated with a lack of health insurance, homelessness, non-adherence to medication regimens, and stigma because of their injection drug use, all of which may discourage this population from seeking professional medical care (Bruce, Kresina, & McCance-Katz, 2010). Primary prevention and targeted interventions for IDUs are needed to prevent disease acquisition and overcome barriers to accessing medical care. INTERVENTIONS AND PREVENTION FOR IDUS: AN OVERVIEW Effective prevention programs, implemented both at the individual- and group-level, can prevent epidemics of blood-borne diseases in IDUs and contain epidemics that are already established or currently emerging (Des Jarlais & Semaan, 2008). IDUs often constitute a marginalized population that may not seek professional medical care due to

19 10 poverty, life circumstances, or mistrust of the healthcare system. Moreover, IDUs often have complex lives in which they must deal with substance abuse, homelessness, STDs, mental health, and other social problems (Academy for Educational Development, 2000). Community-based outreach has been one effective strategy for bringing the services to them through outreach and face-to-face communication. Here, referrals for substance abuse treatment, peer-led or instructor-led health education, condoms, bleach kits, and HIV testing and counseling can be transferred to them (Metzger & Navaline, 2003). A more individualized approach can be used as well. HIV-positive IDUs can be targeted to educate them and discourage them from continuing unsafe behaviors (Metzger & Navaline, 2003). IDUsin the criminal justice system, where injection drug use, tattooing, and high-risk sexual activity are prevalent, are also considered for interventions (Mahon, 1996). Finally, case management is needed for ongoing HIV prevention that focuses on the individual to help that person adopt and maintain their risk-reduction behaviors (Academy for Educational Development, 2000). Substance abuse treatment is another intervention that provides medical, behavioral, and psychological support to help individuals overcome their drug addiction (Academy for Educational Development, 2000). One type is detoxification - a short term management of drug addiction that helps reduce or relieve drug withdrawals while the IDU undergoes counseling to prevent relapses (Collins & McAllister, 2007). Another approach is maintenance (or substitution) therapy which involves using prescribed medications that compete for opioid receptor binding sites to block the effects of illicit drugs like heroin. Unlike detoxification that tries to immediately wean patients off medications once they reach a stable condition, maintenance therapy continues if the patient benefits, is still at risk for relapsing, experiences no side effects, and a health professional believes it is still needed. Methadone is one substitute medication that is offered in highly regulated clinics and has been used since the mid-1960s. More recently however, a combination tablet called Suboxone (consisting of buprenorphine and naloxone) has been used because of its reduced potential for abuse and its acceptable use outside of regulated clinics (Collins & McAllister, 2007). However for those IDUs who cannot stop or will not stop their drug use, a harm reduction approach is taken in which the focus is on reducing or minimizing the adverse

20 11 consequences of drug use (Islam & Conigrave, 2007). For these individuals, the U.S. Public Health Service has recommended to never reuse or share syringes, water, or drug preparation equipment; use new and sterile syringes, water, cookers, and filters obtained from a reliable source to prepare and inject drugs; clean the injection site before with a new alcohol swab to prevent bacterial infections leading to abscesses and endocarditis; and safely dispose of used syringes (U.S. Public Health Service, 1997). Resources that have been established to address these issues have included bleach distribution programs (Normand, Vlahov, & Moses, 1995), syringe dispensing machines that provide IDUs with anonymity and around-the-clock accessibility to sterile syringes in exchange for their used ones (Islam & Conigrave, 2007), and safe disposal boxes for used syringes that can help decrease incidences of needlestick injuries and the reuse of syringes in the community (Riley et al., 1998). SEPs have been instrumental in coupling syringe exchange with other services, including health education and referrals for other health and social services, and pharmacies have also provided a supplementary source of sterile syringes for IDUs (Metzger & Navaline, 2003). This study focuses on the harm reduction approach, particularlysterile syringe sources that are available to IDUs in San Diego. SYRINGE EXCHANGE PROGRAMS SEPs have been established and implemented as an effective way for IDUs to obtain sterile syringes and safely dispose of used ones (Normand et al., 1995). The first SEP was established in Amsterdam, Netherlands in 1984, and since then they have been used in many other countries including France, Great Britain, Australia, and Canada. By 1988 the United States was also operating its first legal SEP (Heimer, 1998; Normand et al., 1995). The advantages of SEPs for the individual IDU are its ability to reach out to IDUs who often do not utilize the health care system because of their poverty or criminal status, offer services to IDUs in a physical and psychological setting that encourage risk reduction, and provide other health services such as bleach kits, condoms, HIV testing, and health education about risk reduction (Heimer, 1998). Moreover, SEPs can refer clients to drug abuse treatment programs to reduce or eliminate altogether their use of drugs, thus demonstrating that these two health interventions can be complementary rather than contradictory (Brooner et al., 1998).

21 12 The benefits of SEPs also extend beyond the individual IDU and into the community at large. Increased access to sterile syringes through SEPs is associated with a decrease in syringe reuse among IDUs (Heimer, Khoshnood, Bigg, Guydish, & Junge, 1998), thus reducing the probability of transmission of blood-borne pathogens. This has been demonstrated through a study that showed a reduction in HIV prevalence in old needles returned to a SEP by IDUs, supporting decreases in HIV incidence (Kaplan & Heimer, 1994); mathematical modeling that have calculated decreases in HIV incidence among SEP users (Kaplan, 1994); a worldwide ecological study showing HIV seroprevalence increased 5.9% per year in 52 cities that did not have SEPs, while seroprevalence decreased 5.8% per year in 29 cities that did have SEPs (Hurley, Jolley, & Kaldor, 1997); and a study in Tacoma, Washington showing that IDUs who did not use the SEP were associated with a six-fold greater risk of Hepatitis B Virus and a sevenfold greater risk of HCV, suggesting that SEPs can lead to significant reductions in these diseases (Hagan, et al., 1995). Having a SEP in a neighborhood does not increase crime in that neighborhood (Marx et al., 2000), does not increase rates of drug use (Normand et al., 1995), does not increase the number of discarded needles on the street (Doherty et al., 1997), and also does not result in the recruitment of first-time drug users (Vlahov & Junge, 1998). In addition, SEPs provide considerable cost savings when compared to the estimated medical costs for treating HIVpositive individuals (Holtgrave & Pinkerton, 1997). However, SEPs have not always been universally accepted in the U.S. During the initial implementation of SEPs, there was concern about their effectiveness in preventing transmission of infectious diseases and the possible implication of increased drug use because of the distribution of free syringes (Hurley et al., 1997). The effectiveness of SEPs was challenged by a study in Montreal, for example, that showed that SEP users had higher HIV seroconversion rates than non-sep users (Bruneau et al., 1997). However due to the observational nature of the study, other researchers have contended that this study s findings did not really prove SEPs as the cause of HIV seroconversion, but instead suggested that SEPs attract high-risk IDUs which is actually an advantage as it provides an ideal location for reaching out to IDUs for public health interventions (Hurley, et al., 1997; Lurie, 1997). In conclusion, public health agencies, medical societies, and federal organizations in the U.S.

22 13 have recognized SEPs as an important intervention for preventing HIV among IDUs (CDC, 1998a). SEPs operate under different mechanisms in the U.S. Their hours of service vary, with some in the U.S. that are open for two hours several times a week while others are open continuously (CDC, 1998b). According to the CDC, buildings (such as clinics, health centers, or storefronts) were most commonly reported as the site of operation, but SEPs also operate through health vans, car stops, and sidewalk tables. Of 126 completed surveys by SEP directors in the U.S., SEPs served clients for an average of 26 hours per week (median: 18 hours/week, range hours/week) (CDC, 2005). Finally, SEPs also vary in exchange policy. For example, exchange policies in California range from a more liberal unlimited, need-based syringe exchange to a more strict one-for-one exchange with a limit on the number of syringes that can be exchanged per visit (Bluthenthal, Heinzerling, Anderson, Flynn, & Kral, 2008). SEP IN SAN DIEGO, CALIFORNIA California s Assembly Bill (AB) 136, which took effect on January 1, 2000, enabled the City or County Councils in California to legally operate SEPs if they declared a local health emergency. In October 2000, the San Diego City Council continuously declared a local health emergency due to the increase in HCV and HIV through syringe sharing, and this led to the funding and operation of the SEP in San Diego (City of San Diego, 2010). However due to the inability to garner enough support in the City Council, the SEP did not operate for one year from 2005 to When AB 136 was amended in 2005 to no longer require local jurisdictions to declare local emergencies and instead enabled them to authorize a SEP with a single legislative act (Clean Syringe Exchange Program [CSEP] Facilitation Committee, 2010), San Diego s SEP was reinstated in 2006 when the City Council passed a resolution to authorize the SEP. The SEP in San Diego is located in a mobile unit that is available for a total of six hours each week in downtown San Diego on Thursday evenings and in the North Park neighborhood on Friday mornings. It operates by a one-for-one syringe exchange policy (i.e. submit one old syringe to receive one new syringe in turn) with a maximum of 30 syringes that can be exchanged at any one session at no cost to the client (Family Health Centers of

23 14 San Diego, 2010). New clients are given a starter prevention kit that includes two sterile syringes, and they are also issued a laminated identification card to provide proof to police officers that they received their syringes from an authorized source (City of San Diego, 2010). The SEP in San Diego provides other services to their clients, including education about risks of disease and referrals for drug treatment, detoxification, drug rehabilitation, testing for infectious diseases, and other social programs (Family Health Centers of San Diego, 2010). In 2010, clients who utilized the SEP were mostly male (75%), White (69%), never married (74%), and not employed (69%). More than half of the participants had a high school degree or more (74%), and only 13% reported living on the streets while 65% owned or rented their place of residence. The median age of participants was 33, a younger age compared to previous years of operation which has been attributed to an increase in younger clients aged 18 to 24 (CSEP, 2010). Participation in the program has increased over the years, which is reflected in the greater number of clients and syringes exchanged. Unfortunately, however, the number of referrals for other health services and social programs decreased in This is attributed to a sharp increase in the number of participants, a decrease in the number of staff, and funding cuts for the SEP and other prevention programs in the community (CSEP, 2010). PHARMACIES AND OTHER SAFE SYRINGE SOURCES Besides SEPs, other syringe sources that are considered safe include hospital emergency rooms (Golub et al., 2005), diabetic patients (Latkin & Forman, 2001), drug stores, hospitals, and outreach workers (Fuller et al., 2002). In medicine and public health, however, SEPs and pharmacies are largely considered the two main sources of sterile syringes (Bluthenthal, et al., 2004). Pharmacies offer distinct advantages that a SEP does not. For example, while SEPs operate only within limited areas and hours, pharmacies are more geographically widespread and have extended operating hours in which they are available to sell syringes (CDPH, 2011). The establishment of pharmacies is less politically controversial within a neighborhood, and funding from the government or another organization is not needed for them to operate (Bluthenthal, et al., 2008; Tempalski, Friedman, Keem, Cooper, & Friedman,

24 ). Moreover, going to a community pharmacy can allow an IDU to avoid possible stigma that might be associated with specialist services, like SEPs, that are directed toward IDUs (Glanz, Byrne, & Jackson, 1989). One barrier, however, is that syringe prescription laws in some locations prevent individuals from purchasing syringes at a pharmacy unless they have a prescription (Burris, Vernick, Ditzler, & Strathdee, 2002). Despite this drawback, evidence has shown that pharmacies can aid in HIV prevention. A cross-sectional study in 2001 in 96 U.S. metropolitan areas found that there was no statistically significant difference in the prevalence of injection drug use between cities that require a prescription for syringe sales and those that do not require a prescription (Friedman, Perlis, & Des Jarlais, 2001). A New York study showed that they do not increase unsafe disposal of needles on the streets (Fuller, et al., 2002). A study conducted in Connecticut after the legalization of NPSS showed no evidence for increased drug use, drugrelated arrests, or needle stick injuries to police officers. That same study also found that compared to before these reforms were made, IDUs were more likely to report buying syringes from pharmacies and less likely to report sharing syringes after the syringe prescription laws were repealed (Groseclose et al., 1995). Thus given the urgency of bloodborne transmission of infections and unsafe disposal of used syringes within communities, public health policy suggests that anti-over-the-counter laws should be repealed rather than to wait for additional supportive evidence (Friedman et al., 2001). Evidence has convinced state and local governments to allow NPSS throughout the U.S. (Riley et al., 2010), and pharmacy sale of syringes is now accepted in 46 states (CDPH, 2008b). In places that have either legalized or not yet legalized NPSS, syringe access laws and individual pharmacy policies in most U.S. states may be interpreted to allow pharmacists some discretion and flexibility in selling syringes to IDUs to prevent disease transmission (Burris et al., 2002; Case, Beckett, & Jones, 1998). For example, a Board of Pharmacy regulation might require pharmacists to determine that persons who purchase syringes have a reasonable cause and will not be using them for an unlawful purpose (Taussig et al., 2002). The ambiguity of this wording can be interpreted by some pharmacists as the prevention of HIV and blood-borne diseases through selling sterile syringes to IDUs is a lawful and medically legitimate action, while others might interpret this as drug use is illegitimate and therefore selling syringes to IDUs is not legal (Taussig et al., 2002).

25 16 The willingness of pharmacists to sell syringes is also influenced by personal beliefs and attitudes. Hesitance to sell syringes to IDUs can be caused by concern about an increase in unsafe syringe disposal around the pharmacy and community, concern about the safety of store staff and other clientele, fear of increased drug use, and fear that the pharmacy business will suffer because of theft or because other clients do not support drug use (Glanz et al., 1989; Rich et al., 2002; Taussig, et al., 2002; Wright-De Aguero, Weinstein, Jones, & Miles, 1998). On the other hand, some pharmacists believe that selling syringes can play a part in the disease prevention effort and are willing to sell syringes, provide free sharps containers for disposal, and give educational material like pamphlets that discuss safer injection practices (Rich et al., 2002). Even in places where syringe sales are allowed, pharmacists may choose to impose additional restrictions on syringe sales, such as requiring purchasers to provide a written statement of legitimate medical need for syringes or allowing customers to purchase only if they do so in large packs of 50 to 100 (Gostin, Lazzarini, Jones, & Flaherty, 1997; Reich et al., 2002b). Discretion among pharmacists has led to wide variation in the practice of selling syringes. Some studies have found discrimination based on race, gender, ethnicity, age, or socioeconomic status (Burris et al., 2002; Compton, Cottler, Decker, Mager, & Stringfellow, 1992; Glanz, et al., 1989; Gostin et al., 1997), while other studies have found little evidence of discrimination in selling syringes, reporting that except for signs like track marks, it is difficult to identify someone as an IDU (Reich et al., 2002a). Focus group results from a study in Tijuana, Mexico revealed that IDUs believed some pharmacists were unwilling to sell to individuals who had an unacceptable appearance, possibly because an unkempt appearance may more strongly profile them as IDUs, and the negative stigma associated with that might drive away customers (Pollini et al., 2010). Before the implementation of California s Senate Bill (SB) 1159 on January 1, 2005, California was only one of five remaining states that required a prescription to purchase syringes in pharmacies (CDPH, 2008b). This bill allows NPSS according to a two-step opt-in mechanism in which interested city and local county health jurisdictions must first authorize a Disease Prevention Demonstration Project (DPDP), and pharmacies within that jurisdiction must then also opt in to register and participate in the program (CDPH, 2008b).

26 17 This law enables individuals 18 years and older to purchase up to 10 syringes from pharmacies, be in legal possession of syringes that were obtained from an authorized source - defined as either a pharmacy or SEP - and possess an unlimited number of syringes if they are safely containerized for disposal. Responsibilities of counties that have authorized a DPDP include maintaining a list of pharmacies that are registered for the program and providing written information to pharmacies that can be shared with syringe customers, including how to access drug treatment, HIV and HCV testing and treatment, and safe syringe disposal. Pharmacies that choose to opt in must register with the county, ensure that needles and syringes are stored and only accessible to authorized pharmacy personnel, and provide at least one method of safe syringe disposal, including on-site syringe disposal, or making personal or mail-back sharps disposal containers available for purchase. Pharmacists must certify that they will either provide the written components given to them by the county or verbally counsel customers. The law also no longer requires that pharmacists record information about the purchaser who did not have a prescription, thus protecting customer privacy and making access to syringes non-threatening (CDPH, 2008b). By 2007, only 17 of 61 local health jurisdictions in California had implemented a DPDP. San Diego County has not yet opted in this (CDPH, 2010) but pharmacists still have some discretion in selling syringes to individuals with or without a prescription. Because these pharmacists may be selling syringes to customers without a prescription and their pharmacies are not registered with a county s DPDP, they are in a position that does not require them to provide written educational information or verbal counseling about disease prevention to their customers. There is a possibility that this could negatively impact prevention efforts of referring IDUs to access to healthcare, disease prevention, and treatment. UNSAFE SYRINGE SOURCES In areas where there is limited or no access to sterile syringes through SEPs, pharmacies, or other safe sources, IDUs obtain syringes from unsafe and often illegal sources. These include street dealers, acquaintances, friends, relatives, sex partners, someone who went to a SEP, shooting galleries, and off the street (Gleghorn et al., 1995).

27 18 These syringe sources can be unsafe because they may involve situations where IDUs may share syringes with many other IDUs in a short period of time (Des Jarlais & Semaan, 2008). For example, using syringes at a shooting gallery can be unsafe because the gallery operator may lend a single syringe to be used by multiple IDUs (Des Jarlais & Semaan, 2008). A drug dealer may reuse the same syringe as he sees a series of customers (Des Jarlais & Semaan, 2008). Hit doctors, individuals who assist clients with injections if they have difficulty injecting themselves, may also reuse syringes(des Jarlais & Semaan, 2008). Moreover, syringe sellers and hit doctors have been found to be both significantly more likely to engage in drug-related risk behaviors, including backloading, injecting with a syringe someone else may have used, passing a used syringe to someone else, injecting more than once per day, and sharing cookers and rinse water compared to IDUs who were not syringe sellers or hit doctors (Friedman et al., 1998; Latkin, Davey, & Hua, 2006). There is also no easy way to demonstrate whether a needle was new and previously unused from some of these sources (Golub et al., 2005). For example, in a study in Baltimore by Latkin et al. (2006) among a subsample of about 200 IDUs who also reported selling needles, most of them did not obtain their needles from SEPs or other safe sources. Three out of five needle sellers who were followed up with an interview said the method they used to distinguish new needles from used ones included detecting the presence of moisture or blood in the needle, a broken seal, or a gap between the plunger and end of the syringe. To prepare syringes for sale, they used techniques like cleaning, drying, and careful alignment of the syringe components to make it similar to a new one. These practices demonstrate the unreliability regarding the sterile condition of syringes obtained from unsafe sources. Qualitative analysis among 18 injectors interviewed in this study demonstrated that half of them reported purchasing needles that did not appear new once they had taken off the cap. While some needle-sellers in this study admitted having received threats of being killed or getting hurt by their purchasers if they discovered they had been sold used syringes, what is more startling is that the needle-sellers efforts to prepare their products were not even necessary at times because some IDUs were so desperate for a needle to satisfy their craving that they would use any syringe they could obtain (Latkin & Forman, 2001).

28 19 Secondary syringe exchange is another method of obtaining syringes with drawbacks that undermine its potential benefits. Secondary exchangers are individuals who obtain needles from other sources including diabetics, SEPs, pharmacies, and other injectors and distribute them directly to other IDUs (Snead et al., 2003; Tyndall et al., 2002; Valente, Foreman, Junge, & Vlahov, 1998). The benefits include the ability to make sterile syringes available to IDUs in more locations and time frames (Lorvick et al., 2006), reach out to IDUs who are hesitant to use a SEP because of fear of the police or disclosure of drug use (Snead et al., 2003), and remove used syringes off the street as they return them to SEPs for more syringes they can sell (Latkin et al., 2006). Disadvantages, however, include syringe exchangers often charge a price for syringes; they have irregular hours and locations which reduces the opportunity for the syringe recipient to receive other services if they had direct contact with an SEP worker; and finally, purchasers are not ensured that syringes are sterile (Huo, Bailey, Hershow, & Ouellet, 2005; Latkin et al., 2006). Additionally, syringe exchangers have been associated with high-risk behaviors, including reusing another IDU s needle, lending used syringes to others, and sharing injection equipment, including those within their own secondary syringe exchange network (De, Cox, Boivin, Platt, & Jolly, 2008; Friedman et al., 1998; Latkin et al., 2006). Syringe sources that are safe and reliable are clearly important to curb the transmission of blood-borne diseases among the IDU community, but a syringe source that is itself involved with high risk behaviors thwarts efforts to accomplish this. Understanding the sociodemographics, injection practices, and other behaviors of IDUs who obtain syringes from each of these different sources can help tailor and improve public health interventions toward IDUs to ensure they are receiving optimal health services. SOCIODEMOGRAPHICS ASSOCIATED WITH SYRINGE SOURCES Some prior studies have identified characteristics and behaviors of IDUs by examining one syringe source (e.g. SEP users versus non-sep users). However this literature review will mostly focus on those that have compared multiple syringe sources in the same study, a method also utilized for this present study s analysis. This will offer a better comparison of IDUs behaviors than if multiple studies that were conducted using different