Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community — A potential conduit to improved HIV treatment outcomes

Abstract

BackgroundHIV-infected prisoners experience poor HIV treatment outcomes post-release. Directly administered antiretroviral therapy (DAART) is a CDC-designated, evidence-based adherence intervention for drug users, yet untested among released prisoners. MethodsSentenced HIV-infected prisoners on antiretroviral therapy (ART) and returning to New Haven or Hartford, Connecticut were recruited and randomized 2:1 to a prospective controlled trial (RCT) of 6months of DAART versus self-administered therapy (SAT); all subjects received case management services. Subjects meeting DSM-IV criteria for opioid dependence were offered immediate medication-assisted treatment. Trained outreach workers provided DAART once-daily, seven days per week, including behavioral skills training during the last intervention month. Both study groups were assessed for 6months after the intervention period. Assessments occurred within 90days pre-release (baseline), day of release, and then monthly for 12months. Viral load (VL) and CD4 testing was conducted baseline and quarterly; genotypic resistance testing was conducted at baseline, 6 and 12months. The primary outcome was pre-defined as viral suppression (VL<400copies/mL) at 6months. ResultsBetween 2004 and 2009, 279 participants were screened, of which 202 met eligibility criteria and 154 were ultimately enrolled in the study; 103 subjects were randomized to DAART and 51 to SAT. Subjects were mostly male (81.2%), people of color (87.0%), had an alcohol use disorder (39.7%), had underlying depression (54.2%), were virally suppressed (78.8%) and had a mean CD4=390.7cells/mL. ConclusionsOutcomes from this RCT will contribute greatly to HIV treatment outcomes after release from prison, a period associated with adverse HIV and other medical consequences.