HIV+ drug users have derived less benefit from antiretroviral therapy (ART) compared to others with HIV. Many cycle into and out of the criminal justice system. The structure of prisons facilitates abstinence from drugs and focus on health-related issues, such as ART, which can be administered as directly observed therapy (DAART). The structure of DAART in prisons has contributed greatly to impressive health outcomes (improvements in viral load, CD4 and mortality) compare to community-derived individuals. Despite the effectiveness of behavioral case management programs linking HIV+ prisoners to community care, none have demonstrated continued successful clinical outcomes (viral load, CD4, mortality) after prison release. This may result from the lack of structure for many who leave prison- including the loss of supervised medication administration. Data from our randomized controlled trial RCT) of a community-based enhanced DAART+ intervention targeting HIV+ drug users (Project TRUST) demonstrates improved adherence, reduced viral load and increased CD4 counts compared to those who self-administer therapy (SAT). This enhanced intervention incorporates additional components (clinical care, drug treatment, case management) that have been successfully integrated into DOTS programs for TB (known as DOTS-PLUS) and found to be more effective than DOTS alone. Additional pilot data with 25 released HIV+ prisoners randomized to DAART+ and SAT suggests that linkage and retention in this program is feasible. We draw on our work with development of prison-release programs, community-based DAART+ and the conduct of research with HIV+ drug users to conduct the proposed research. To test the idea that continuation of DAART is feasible and likely beneficial after release from prison, we propose to conduct a randomized controlled trial among released HIV+ prisoners receiving ART comparing an established DAART+ intervention with the usual standard of care (SAT). This will be accomplished using the Community Health Care Van (CHCV) that operates within five distinct neighborhoods in New Haven, CT. The proposed project is called Project CONNECT. In this proposal, we aim to use a RCT to compare the biological (HIV-1 RNA levels, CD4 counts, genotypic resistance), clinical (retention in clinical care, HIV quality of life [QoL]) and behavioral (adherence to ART, relapse to active drug use) outcomes among recently released HIV+ prisoners randomized to receive an already established and enhanced community-based DAART+ intervention versus SAT. In this clinical trial, outcome measures will be analyzed using intention-to-treat and data-as-observed approaches. The investigators draw upon their experience developing and evaluating community-based DAART+ interventions for HIV+ drug users (Project TRUST) and behavioral case management interventions for soon-to- be-released prisoners (Project TLC). It is therefore likely that the stated aim will be successfully accomplished, despite the challenges of working with prisoners and drug-using populations. ? ?
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