Last updated on July 2015

Enhanced Access to HIV Care for Drug Users in San Juan Puerto Rico

Brief description of study

The overall goal of this project is to implement and evaluate a community-level, structured approach to enhance HIV care access and retention for drug users in San Juan, Puerto Rico. The "Enhanced HIV Care Access and Retention Intervention" will: 1) identify drug users living with HIV who either do not know their HIV status and/or are not engaged in HIV care; 2) provide direct HIV care services through a mobile health van; and 3) support identified HIV-infected drug users with patient navigators to enhance their ability to engage in HIV care and substance abuse treatment, to initiate antiretroviral therapy, and maintain adherence to their treatment regimens. The structural enhanced care approach will be evaluated through a randomized roll-out design, a refinement of the stepped-wedge design. The community-level success of the intervention will be assessed by evaluating virologic suppression (primary biological outcome), increased attendance to HIV care visits, uptake of antiretroviral therapy, adherence to HIV treatment regimens, and decreased substance use (as secondary behavioral outcomes) in an independent cohort of HIV-positive individuals drawn from each of the neighborhoods included in the intervention. We will also evaluate the implementation process and cost of the enhanced care approach including implications for cost-effectiveness, feasibility of expansion, and sustainability.

Detailed Study Description

Study Design The overall goal of this project is to implement and evaluate a community-level, structured approach, the "Enhanced HIV Care Access and Retention Intervention" for drug users in San Juan, Puerto Rico. It will bring HIV care directly to five San Juan neighborhoods in which a high proportion of HIV-positive injection drug users (IDUs) reside. The enhanced care intervention is comprised of 4 components: A) a neighborhood-level HIV Testing Campaign to identify HIV-positive drug users who are not aware of their HIV status, B) a Treatment Re-engagement Campaign using patient navigators for out-of-care HIV-positive IDUs, C) a Patient Navigator Linkage to Care and Substance Abuse Treatment team for both newly diagnosed and out of care HIV-positive IDUs and D) a Mobile HIV Care Clinic staffed by HIV clinicians to facilitate linkage into and retention in care. The intervention will be evaluated using a randomized roll-out design, a refinement of the stepped-wedge design. The intervention will be rolled-out at 6-month intervals in each of the five neighborhoods. The order in which neighborhoods will receive the intervention will be determined randomly. Once a neighborhood begins to receive the intervention, it will continue receiving the intervention throughout the remaining period of the study. The number of individuals served by the intervention who enter into care, their appointment adherence, viral loads and health service and substance abuse treatment utilization will be documented. The success of the intervention will be determined by examining the proportion of virologic suppression over time in an independent assessment cohort of approximately 400 HIV-positive drug-using individuals drawn from the five neighborhoods included in the intervention. The primary evaluation outcomes of this study are to see whether the intense saturation of our intervention results in persons in the assessment cohort being offered and receiving intervention services and the impact on their viral load. Assessment Cohort Exposure to the intervention will be evaluated by the assessment cohort as the intervention strategy is rolled out in each of the 5 intervention neighborhoods. Eligible participants (defined below) will be scheduled for a baseline appointment, and asked to bring documentation of their HIV status if available. At the baseline visit, participants will: 1) review and sign the consent form; 2) complete a rapid HIV test; 3) provide blood to assess CBC (including CD4 and plasma HIV RNA; and 4) complete a behavioral assessment using an audio computer assisted interview (ACASI). Participants recruited into the assessment cohort will be counseled on the importance of HIV care and risk reduction practices following existing standards within Puerto Rico. At the end of the baseline visit, participants will be compensated for their time and travel costs and reminded about the next scheduled visit in six month's time. Participants will then be followed at six month intervals for a period of 30 months (and 36 months for neighborhood 5). At each assessment points they will be asked to complete the behavioral assessment using an ACASI and to have their blood drawn for CD4 and viral load.

Clinical Study Identifier: NCT01792752

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Recruitment Status: Open

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