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

• Published in: Contemporary clinical trials 2012-03, Vol.33 (2), p.436-444
• Main Authors: Saber-Tehrani, Ali Shabahang, Springer, Sandra A, Qiu, Jingjun, Herme, Maua, Wickersham, Jeffrey, Altice, Frederick L
• Format: Article
• Language: English
• Subjects: Adherence; Adult; Anti-HIV Agents - administration & dosage; Antiretroviral therapy; Cardiovascular; Directly administered antiretroviral therapy (DAART); Directly Observed Therapy - methods; Female; Follow-Up Studies; Hematology, Oncology and Palliative Medicine; HIV; HIV Infections - drug therapy; HIV Infections - virology; HIV/AIDS; Humans; Male; Middle Aged; Prisoners; Prospective Studies; Substance abuse; Treatment Outcome; Viral Load
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2011.11.002

Abstract Background HIV-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. Methods Sentenced 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 6 months 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 6 months after the intervention period. Assessments occurred within 90 days pre-release (baseline), day of release, and then monthly for 12 months. Viral load (VL) and CD4 testing was conducted baseline and quarterly; genotypic resistance testing was conducted at baseline, 6 and 12 months. The primary outcome was pre-defined as viral suppression (VL < 400 copies/mL) at 6 months. Results Between 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 = 390.7 cells/mL. Conclusions Outcomes from this RCT will contribute greatly to HIV treatment outcomes after release from prison, a period associated with adverse HIV and other medical consequences.