This revised application is submitted in response to DA 04-015, HIV/AIDS and Other Infections Among Drug Users in the Criminal Justice System. Annually, over 1/4 of all HIV+ individuals in the U.S. pass through the correctional system. Treatment with HAART in correctional settings, for many, has resulted in improvements in morbidity, mortality, viral load (VL) and CD4 counts. The benefits from HAART derived while incarcerated are lost, unfortunately, for many after release to the community. Released HIV+ prisoners have high rates of recidivism to prison, relapse to illicit drug use and poor HIV treatment outcomes. Case management (CM) programs, the community standard for released HIV+ prisoners, have not effectively incorporated effective adherence and opiate relapse prevention interventions for opiate dependent HIV+ patients. Buprenorphine, a partial opiate agonist with low abuse and diversion potential, has been approved for treatment of opiate dependence. Therefore, drug treatment without stringent safeguards found in methadone maintenance programs can now be effectively integrated into prison release interventions. Novel health care delivery systems for released HIV+ prisoners are urgently needed-especially ones that incorporate drug treatment and adherence interventions. The R21 mechanism is exploratory in nature and the interventions are predicated in changes in the Behavioral Model of health care utilization that improve predisposing factors and enabling resources. Therefore, the specific aim for this investigation is to develop and pilot test novel health delivery interventions for HIV+ prisoners who are transitioning from the correctional to the community setting. The proposed work will be conducted with a subgroup of opiate dependent patients who are participating in a new NIDA- funded study (Project CONNECT) that is a randomized controlled trial of directly administered antiretroviral therapy (DAART) versus self-administered therapy (SAT). Subjects in both groups receive CM. In this R21 application (Project BRIDGE), opiate dependent subjects within the 2 study groups of Project CONNECT will be randomized to receive buprenorphine maintenance treatment (BMT). For the purposes of the exploratory R21, the 4 study groups will be: 1) CM alone (SAT only group); 2) CM+BMT; 3) CM+DAART; and 4) CM+BMT+DAART. Outcomes of interest will include drug treatment (opiate relapse and re incarceration) and HIV treatment (VL, CD4 and adherence) outcomes. Process measures will be used to refine the intervention. Information obtained from these pilot studies will be used to inform the future development of a randomized controlled trial. The likelihood of success for these pilot studies includes the newly available study design and resources from Project CONNECT, experience of investigators with DAART and BMT and the existing collaborations between the correctional, drug treatment and community release programs. ? ? ? ?
