DAART+ AS A STRUCTURAL HIV INTERVENTION IN METHADONE MAINTENANCE

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DESCRIPTION (provided by applicant): Anti retroviral (ARV) adherence proves difficult for many HIV-positive patients with substance use disorders. Non-adherence results in poor response to therapy, viral drug resistance, cross-resistance and the spread of drug-resistant viral strains. Based on Directly Observed Therapy (DOT) for the treatment of tuberculosis, Directly Administered Antiretroviral Therapy (DAART) improves health outcomes among substance-abusers while the intervention is present (Conway et al., 2004; Lucas et al., 2004). Methadone maintenance treatment (MMT) is an ideal setting for DAART because it requires frequent contact between patients and health care providers. This Stage 1 treatment development proposal will pilot and evaluate an innovative enhanced DAART (DAART+) intervention for MMT patients to promote long-term, autonomous antiretroviral regimen adherence. DAART+ is theoretically grounded in the Information-Motivation-Behavior Skills model (1MB) of adherence and extends the traditional DAART model with both structural and individual-level components including the administrative modification of clinic policies to support the provision of antiretroviral medication, staff HIV education, patient adherence counseling by a clinical pharmacist and tapered DAART+ methods. The study will consist of: (1) a 4-month developmental phase to refine and standardize the treatment manual, outcome measures and structural components of DAART+ and; (2) a 20- month pilot intervention phase to collect preliminary data on the effectiveness of DAART+ in improving medication adherence and reducing HIV-1 RNA viral load. The design is a modified, interrupted time-series removal with 6-months of DAART+, a 3-month gradual DAART+ taper and a 3-month follow-up without DAART+. We will examine substance use and depressive symptoms as moderators of adherence. As a new investigator, the R21 mechanism allows for independent status and provides significant research training and pilot data for the development of a future R01 clinical trial. Linking HIV/AIDS services with substance abuse treatment is an important public health intervention with potential to advance both fields. Moreover, increased antiretroviral adherence is associated with a large decrease in the cost of treatment for HIV-positive patients, as well as a decrease in the incidence of opportunistic infections, hospital utilization and the development of antiretroviral-resistant strains.