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RESEARCH AND PRACTICE |
The authors are with the Harlem Community & Academic Partnership at the Center for Urban Epidemiological Studies, New York Academy of Medicine, New York, NY.
Correspondence: Requests for reprints should be sent to Crystal M. Fuller, 722 West 168th Street, Room 718, New York, NY 10032 (e-mail: cf317{at}columbia.edu).
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ABSTRACT |
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Objectives. Research has indicated that there is minimal use of pharmacies among injection drug users (IDUs) in specific neighborhoods and among Black and Hispanic IDUs. We developed a community-based participatory research partnership to determine whether a multilevel intervention would increase sterile syringe access through a new policy allowing nonprescription syringe sales in pharmacies.
Methods. We targeted Harlem, NY (using the South Bronx for comparison), and disseminated informational material at community forums, pharmacist training programs, and counseling or outreach programs for IDUs. We compared cross-sectional samples in 3 target populations (pre- and postintervention): community members (attitudes and opinions), pharmacists (opinions and practices), and IDUs (risk behaviors).
Results. Among community members (N = 1496) and pharmacists (N = 131), negative opinions of IDU syringe sales decreased in Harlem whereas there was either no change or an increase in negative opinions in the comparison community. Although pharmacy use by IDUs (N=728) increased in both communities, pharmacy use increased significantly among Black IDUs in Harlem, but not in the comparison community; syringe reuse significantly decreased in Harlem, but not in the comparison community.
Conclusions. Targeting the individual and the social environment through a multilevel community-based intervention reduced high-risk behavior, particularly among Black IDUs.
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INTRODUCTION |
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Recognizing this need, New York State enacted the Expanded Syringe Access Demonstration Program (ESAP), which permits pharmacy syringe sales without a prescription. Since January 1, 2001, individuals aged 18 years or older have been permitted to purchase and legally possess up to 10 syringes without a prescription from pharmacies registered with the New York State Department of Health. Early data revealed that IDUs in East and Central Harlem (referred to as "Harlem" hereafter) and South Bronx minimally participated in ESAP.11–14 In addition, studies indicated that Black and Hispanic drug users were less likely to use pharmacies as safe and legal syringe sources compared with their White counterparts, irrespective of geographic location.11,12,14,15
In the summer of 2001, the Harlem Community and Academic Partnership recognized the disparities in both the use of ESAP and the burden of HIV disease in their community, and organized an intervention work group to address this issue. The partnership had been formed 2 years earlier, as described elsewhere,16 and currently includes 30 community-based organizations in Harlem, 4 academic institutions, and the local health department. Because of the complex social factors (e.g., police harassment, various types of discrimination) that contribute to injection risk, and previous work that shows how contextual factors (e.g., public policy, cultural norms, illegality of drug use) may influence individual behaviors, a multilevel design was chosen.17–19 Using a community-based participatory research approach,20 we targeted 3 populations: community residents, pharmacists, and IDUs. The specific goals for the intervention were (1) to sensitize community residents to drug users and dispel negative myths by providing education on the positive affect that ESAP could have in their community (e.g., reducing the risk and burden of HIV disease), (2) to provide education to pharmacists about what was and was not required by the law and provide information to help dispel negative perceptions of drug users, and (3) to increase awareness of ESAP among IDUs and provide the location and hours of ESAP-participating pharmacies and information about safe injection and syringe disposal practices. All activities were to be performed in a culturally appropriate manner to specifically reach Black and Hispanic IDUs.
We report the final results of our non-randomized, multilevel intervention, including pre- and postintervention evaluations in both intervention (Harlem) and comparison (South Bronx) communities. Using a community-based participatory research approach, we obtained data on 3 target populations: community residents, pharmacists, and IDUs.
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METHODS |
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Pharmacies were selected from a database of listings from the New York State Department of Health combined with listings obtained from Yellowpages.com (http://www.yellowpages.com), an online directory collected from phone books and new business listings. Because of the modest number of pharmacies registered in South Bronx, the Bedford-Stuyvesant community in Brooklyn (with similar demographics) was added to the comparison community, which yielded 106 pharmacies in the comparison community and 45 in the intervention community. Pharmacies were excluded from the study if their phone was disconnected, if they did not provide over-the-counter services, or if the supervising pharmacist was unwilling to participate. Pharmacists were only called when customer volume was expected to be low (on the basis of pilot testing). In the intervention community, 53% (n = 24) of the pharmacists participated in the preintervention phone survey and 62% (n = 28) participated in the postintervention survey. In the comparison community, 44% (n = 47) and 31% (n = 33) participated in the pre- and postintervention surveys, respectively. Although it is likely that some pharmacists surveyed preintervention were the same pharmacists surveyed post-intervention, confidentiality issues prevented linking these individuals at these 2 time points.
To enhance feasibility and efficiency of this study, 2 preexisting IDU studies that used similar recruitment techniques provided the samples for pre- and postintervention periods. IDUs for both studies were recruited at community research sites within each target community using targeted and respondent-driven sampling methods. The first study was an observational cohort study that targeted IDUs between 18 and 35 years of age and the second was an observational cross-sectional study (Urban Resource Center Cross-Sectional Survey) conducted among IDUs aged 18 years and older. The final sample (combined across each study) included 278 IDUs in the preintervention period (intervention = 134; comparison = 144) and 450 IDUs in the postintervention period (intervention = 239; comparison = 211). Because these studies ran concurrently and were conducted by the same research staff, participants were allowed to participate in only 1 of the 2 studies.
Data Collection
Surveys were conducted pre- and postintervention for each population in the intervention and the comparison communities. An anonymous random-digit-dial telephone survey was conducted among community residents preintervention (February 2002) and postintervention (July 2003). In addition to demographics, respondents were asked about approval or disapproval of drug use, and the effect of ESAP on street-discarded syringes, crime, drug use, and the spread of HIV. Surveys lasted approximately 25 minutes and were administered in English and Spanish. Spanish-language surveys had previously been back-translated for verification of consistency.
Pharmacists also participated in anonymous, cross-sectional surveys regarding their opinions and attitudes about ESAP both pre-intervention (April 2002) and postintervention (August 2003). In addition to individual pharmacist demographics, pharmacists were asked about their support for ESAP and their opinions of ESAP’s effect on street-discarded syringes, drug abuse, and HIV transmission.
Data collected among IDUs from both observational studies focused on social and behavioral risk factors for HIV, hepatitis C virus, and hepatitis B virus infections. In addition to existing sociodemographic data, new ESAP-related variables were added to both surveys and included knowledge about ESAP, source of pharmacy syringes, syringe sharing, and syringe reuse. IDUs surveyed from January 1, 2001, to June 31, 2002, comprised the preintervention sample and those surveyed from July 1, 2002, to September 1, 2004, comprised the postintervention sample.
Intervention Activities
The Harlem ESAP Intervention Project spanned between July 1, 2002, and June 30, 2003, and was fully designed and implemented by the Intervention Work Group. Activities targeting community members included visits to IDU-servicing community-based organizations and training programs conducted at these organizations, presentations to Harlem community boards, participation in health fairs and harm reduction meetings, and an ESAP community forum at a local church. Pamphlets were distributed and posters were hung in community centers, hair salons, barbershops, and bodegas.
All ESAP-registered and non-ESAP-registered pharmacists in the intervention community were visited and provided with ESAP information and registration assistance. They were also invited to a pharmacist and pharmacy clerk training workshop. Each registered pharmacy received pharmacy-tailored ESAP posters, pamphlets, ESAP guides, free safe syringe-disposal containers (Fitpacks), and regular program progress updates.
Intervention activities for IDUs included education about ESAP during HIV pre- and posttest counseling, small group training sessions regarding ESAP and safe syringe-disposal practices, and ESAP stickers and posters posted in communities where there was high drug use. The New York Academy of Medicine and other IDU-servicing community-based organizations conducted 1-on-1 and small group outreach to IDUs by disseminating ESAP pamphlets, which included a list and map of all registered pharmacies in Harlem. All ESAP educational materials included a toll-free telephone number (1-866-SAFE-SHOT) for a service that provided 24-hour information about ESAP, safe injection, syringe disposal, and legal matters to IDUs and pharmacists and staffed during regular business hours and voice-prompted after business hours.
Data Analysis
Intervention activity materials were tabulated by population and activity category. Chi-square tests were used to compare pre- and postintervention periods for community resident, pharmacist, and IDU cross-sectional samples. In addition, pharmacy use reported by IDUs during the pre- and postintervention periods was stratified by race/ethnicity to determine the effect of the intervention on Black and Hispanic IDUs. P values < .05 were used to help determine significant differences for all group comparisons.
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RESULTS |
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presents the intervention activities implemented at each targeted population level. At the community level, there were 90 contacts with community-based organizations, which included 4 community-based organization training sessions or forums, 9 health fairs or community meetings, and 50 1-on-1 visits (3 visits or contacts with each community-based organization on average). This resulted in the distribution of 11400 ESAP pamphlets, 1485 ESAP posters, 510 ESAP stickers, and 60 Fitpacks. With regard to pharmacies, there were 128 1-on-1 visits (3 visits to each pharmacy on average), and 2 pharmacist training sessions or forums that resulted in the distribution of 95 ESAP pharmacy guides, 94 ESAP posters, and 586 Fitpacks. Finally, 60 1-on-1 counseling sessions, 16 focus groups, and 87 IDU-targeted outreach events were conducted. A total of 5350 ESAP pamphlets, 750 ESAP stickers (posted on billboards, construction scaffolding, and vacant buildings) and 2000 Fitpacks were distributed.
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shows pre- and postintervention awareness and perceptions of ESAP among Harlem (intervention) and South Bronx (comparison) community residents. There were no sociodemographic differences in pre- and postintervention samples in the intervention community or the comparison community with respect to age, gender, and education. Black and Hispanic residents were the majority in both communities. However, there were fewer Black (48%) and more Hispanic residents (44%) in the postintervention sample than in the preintervention sample (54% and 36%, respectively; P< .03). Most residents from both communities were unaware of non-prescription syringe sales at pharmacies. However, there was a significant increase in ESAP awareness postintervention (14%) compared with preintervention (6%; P< .01) in the intervention community with no change in the comparison community.
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Pharmacists
Attitudes and perceptions of ESAP-registered pharmacists about nonprescription syringe sales to IDUs, both pre- and post-intervention, are reported in Table 3. There were no differences in the pre- and post-intervention pharmacist samples with respect to gender and pharmacy type (chain vs independent). However, there were significantly more Black (26%), and fewer White pharmacists (17%) sampled postintervention than preintervention (14% and 32%, respectively; P< .01) in the intervention community. There were significantly more Whites (26%) and fewer Middle Eastern pharmacists (3%) sampled postintervention than preintervention (20% and 38%, respectively; P< .02) in the comparison community. A smaller proportion did not support ESAP (27%), and a larger proportion reported they were undecided (23%) postintervention than preintervention (41% and 0%, respectively; P< .06) in the intervention community. This difference was only marginally significant. In the comparison community, there was a significantly larger proportion that did not support ESAP (63%) and fewer who supported ESAP (34%) postintervention than preintervention (39% and 61%, respectively; P< .05). The majority of registered pharmacists surveyed reported selling syringes during both time periods for each community.
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Injection Drug Users
Table 4 illustrates injection practices pre- and postintervention among IDUs in the intervention and comparison communities. In the intervention community, the mean age of IDUs was significantly younger during the postintervention period (36 years) compared with preintervention (39 years; P<.01). However, in the comparison community, mean age did not differ by period. In both communities, there was a significant increase in the proportion of men surveyed when comparing pre- and postintervention periods. There tended to be more Hispanic (66%) and White (18%) and fewer Black IDUs (16%) in the intervention community postintervention than preintervention (49%, 8%, and 43%, respectively; P<.01). A similar trend was observed in the comparison community except that there were fewer White IDUs in the postintervention than the preintervention period, and fewer Black IDUs overall.
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To further examine the effect of the intervention on IDUs by race/ethnicity, stratified analysis revealed that Black IDUs in the intervention community were significantly more likely to use pharmacies postintervention (22%) than preintervention (5%; P< .02), although there was no significant difference in pharmacy use among Black IDUs in the comparison community postintervention (11%) than preintervention (8%; P > .99). There was also a significant increase among Hispanic IDUs in both intervention and comparison communities when comparing postintervention and preintervention periods (34% vs 15%, P< .005; and 29% vs 13%, P< .001, respectively).
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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Elements of multilevel community interventions (or structural interventions) with multilevel pre- and postintervention evaluation and comparison communities have been described in the literature.21 Community and academic partnerships have also been described22,23 and used in community-based participatory research to address a variety of health-related problems,20,24 but to date most partnerships have been evaluated on process rather than outcome. Although multilevel interventions (individual, provider, community) have been considered important to the research community,25–28 they have been designed and led by research professionals.25,26 Examples include nonrandomized pre- and postintervention designs for disease prevention projects, which in general have the closest similarity to the results reported here. For instance, HIV intervention programs for drug users have used community outreach to achieve reductions in individual-level risk behaviors,29 but generally the evaluations have been conducted using individual pre- and postintervention questionnaires. Drug abuse treatment has been evaluated at the individual level by comparing in-treatment with out-of-treatment populations,30 but follow-up typically has been limited to in-treatment modalities. Using community ecological designs, injection risk behaviors of syringe exchange program participants and nonparticipants have been evaluated before the start of the syringe program rather than after.1,31 More recently, Connecticut policy makers changed a law to allow nonprescription syringe sales in pharmacies, and separate evaluations of drug users and pharmacists show that program use and changes in risk behavior occurred after the law was changed.32,33 Data from Connecticut have also been compared with data from other states that had more restricted syringe access.34 These latter studies are what stimulated the law change in New York State as well as the multilevel intervention program we described.
Limitations
Although our findings provide solid evidence of an intervention effect, there were a few limitations in the analytic approach. The use of cross-sectional data to evaluate the effect of a community-based multilevel intervention on individual behavior may be subject to some sources of bias and may be less sensitive to the effect of recent behavior change than prospective studies. However, the pre- and postintervention cross-sectional analytic method chosen here is a prudent and more cost-efficient first approach to determine the effect of a multilevel design. Separate cross-sectional evaluations of each level may also be limited in that they do not provide estimates of the independent effects of each factor examined (i.e., community-level and pharmacy-level factors) on IDU behavior. If the sample size permitted, such information would be significant from a public health and research perspective by identifying the role of the social environment, which in turn lends further support for a multilevel intervention design. However, separate analyses have merit and provide firm evidence of the intervention effect.
As with any community intervention, there was the potential for a contamination effect; our finding of increased pharmacy use in both communities may be an example of this effect. However, in the comparison community there was a decrease in IDU knowledge of the legality of syringe possession despite an increase in pharmacy use. A possible explanation for these contradictory findings in the comparison community is that some ESAP information may have spread more efficiently among drug-use networks, such as which pharmacists are selling syringes, as opposed to more detailed information, such as when syringes are legal and illegal to possess.
We must also note the possibility of selection bias which may partially explain the changes that we have observed. Specifically, pre- and postintervention IDU samples differed with respect to age, race, and gender, which could have been independently associated with pharmacy use. There have been no differences observed in pharmacy use by gender, although older IDUs and minorities have been significantly less likely to use pharmacies in previous reports.12–14,35 The fact that the postintervention sample tended to be younger and that there was a larger proportion of White IDUs in the intervention community may partially explain the increase in pharmacy use. Yet some of the demographic differences provide notable evidence of an intervention effect. For example, the increased proportion of Hispanic and Latino IDUs coupled with the increased pharmacy use among this group in both communities may suggest more of a contamination effect, which in fact is a positive effect from a public health perspective given their minimal use before the start of this project.11,14,15,35
The pharmacy participation rates may also indicate the possibility of selection bias; for example, those that participated may have been more likely to support ESAP. To assess this potential bias, we compared the participants to the nonparticipants with regard to pharmacy type (chain vs nonchain) because previous data indicated nonchain pharmacies to be more supportive of ESAP. For pre- and postintervention samples in each community, there were no differences with respect to the proportion of nonchain pharmacies, which provides some evidence of balance with respect to ESAP supporters. We also noted race/ethnicity differences in pre- and postintervention pharmacy samples in both communities. However, previous research has not found an association between pharmacists’ race/ethnicity and ESAP support.36
Finally, the use of community-based participatory research could also be a drawback for others who want to conduct similar interventions, because it can take a year or more to develop trusting and productive relationships between academic centers and community-based organizations20; thus, in order for this approach to work with urgent public heath problems, a viable partnership needs to be in place. The evaluation presented here suggests that establishing this type of partnership can be a worthwhile investment for future programs implemented in this community.
Conclusions
Although structural or multilevel intervention approaches have been suggested for a variety of public health problems—including HIV prevention as early as the year 200021—this is the first community-based multilevel intervention, to our knowledge, that has been evaluated in the HIV-prevention arena with pre- and postintervention measures for community, provider, and individual populations. The findings presented here have important implications for both research and practice. Multilevel interventions, which take into account critical elements of the social environment that may hinder positive behavior change, should be considered a viable disease prevention strategy. Without addressing multiple competing social forces, a public health program such as ESAP will be minimally used, particularly by Black and Hispanic drug users who historically have been mistreated. We have shown here that this intervention strategy may be an efficient and effective strategy to increase the likelihood of individual behavior change and, consequently, a strategy to help reduce racial disparities in a variety of health outcomes.
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Acknowledgments |
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We acknowledge the outreach and interview staff as well as the project directors for their efforts in maintaining quality data collection.
Human Participant Protection
This study was approved by the institutional review board at New York Academy of Medicine where all research activities were conducted. All study participants underwent informed consent.
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Footnotes |
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Contributors
C.M. Fuller designed the research study, directed all data collection and analysis, and led development of the article. S. Galea designed the research study, codirected all data collection, and assisted with article development. W. Caceres was the primary contributor to the article development. S. Blaney conducted all data analysis. S. Sisco coordinated data collection efforts and provided assistance with article development. D. Vlahov assisted with the research design and provided key input in all data collection efforts.
Accepted for publication February 1, 2006.
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References |
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