The proposed R21 (PA-01-023) application by a new investigator is for a 3-year developmental project to design and assess the feasibility of a four-session, theory-based intervention to promote adherence to highly active antiretroviral therapy (HAART) among HIV positive drug-involved individuals. HAART has demonstrated unprecedented success in the inhibition of HIV replication; however, its efficacy depends upon strict adherence to the regimen. This novel intervention focuses on preparation for adherence before treatment is initiated and emphasizes commitment to adherence through increased knowledge, physician-patient collaboration, and negotiation strategies for removal of barriers to adherence. The findings will be used to inform a future RO1 application. A recent shift in antiretroviral prescribing protocols has meant that physicians are now prescribing HAART later in the disease trajectory than what was previously recommended. The shift in the prescribing protocol provides a window of opportunity to prepare individuals to adhere to HAART, rather than hastily prescribing the difficult regimen and then combating non-adherence. Physicians routinely judge whether or not they believe an individual will be adherent to HAART, and then prescribe or withhold treatment based on that judgment. The reason most often cited by physicians for withholding treatment is active drug involvement. Drug involvement, however, is an inconsistent predictor of non-adherence when other factors such as mental health are controlled for. There have been several intervention studies focused on non-adherence in the past several years; however, few have focused specifically on drug-involved individuals. There have been no studies on preparation to adhere to anti retro-virals with HIV positive adults. In the first phase of this study, the intervention and instruments will be refined through the use of focus groups comprised of both the study population and medical professionals who are currently working with the study population. During the second phase of the study, the feasibility and preliminary outcomes of the pilot controlled clinical trial will be examined. Subjects will be recruited after they have been determined to be medically appropriate for treatment but either have not yet begun treatment, or have been on an extended break from treatment (> 3 months). Subjects will initiate HAART immediately following the intervention.
