To meet the specific aims of the study, we will be involved with coordination of data that is being collected in a variety of different ways. These include original phone surveys, ethnographic interviews, and street surveys of discarded needles. In addition, we plan modifications of currently funded interview studies of drug users about HIV and HCV risk to include information about sources, acquisition and disposal of syringes. The overall approach is to consider each of the aims separately and using an historical control design, examine data before and after implementation of the New York State Expanded Syringe Access Program (ESAP). After a crude overall analysis of data for each aim, which we recognize can be subject to artifactual influences, we will use categorize data by proximity to participating programs. This will be facilitated by information supplied by the AIDS Institute of the NY State Department of Health (letter of agreement attached in Appendix C) that gives basic information including location of pharmacies and agencies that are registered in the expanded syringe access program. The goal of these analyses for aims where this is appropriate (e.g., IDU reported risk behaviors and discarded needles) is to identify differences in effect by proximity to programs. Finally, we will examine data across the specific aims using a """"""""patterns of evidence"""""""" approach to consider generating inferences about the overall effects of the program. For the rest of the Methods Section, we will describe four phases in our approach to the science of this coordinated effort. The phases will include 1) a brief description of the study for each aim (Phase I), 2) the plan of global analysis (e.g., before/after analyses) to address each specific aim (Phase II), 3) the plan of analysis for a refined approach (e.g., comparisons by proximity to participating programs) in addressing each specific aim (Phase III), and 4) the """"""""patterns of evidence"""""""" strategy for reviewing data across the specific aims. For phase I, as we address each of the specific aims of this study, we will describe each of the relevant prior and on-going studies that will be used to address that particular aim(s). In doing this, we will briefly describe the study population, method of data collection, primary exposure variables and laboratory methods (if applicable) within each contributing data set. We will also methodologically describe areas that are not exactly within the scope of this proposed study but we feel make sense to consider given the ease in which we are able to access data to explore these issues (e.g., accidental needle sticks). Various statistical methods will include generalized estimating equation method and multivariate analyses. Few states in the U.S. have expanded their laws to increase access to sterile syringes and here, in New York, an innovative opportunity to compare three modes of legal sterile syringe access (syringe exchange programs, pharmacy and health care provider) exists. An experienced team of researchers across three different institutions has come together to evaluate this Program (ESAP) so that new information about the effectiveness of expanded access can be collected to decrease transmission of HIV and other blood-borne infections.
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