title: 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: 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.
authors.affiliation: Yale University School of Medicine, Department of Medicine, Section of Infectious Diseases, AIDS Program, United States.
authors.forename: Ali Shabahang
authors.initials: AS
authors.lastname: Saber-Tehrani
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Springer
authors.forename: Jingjun
authors.initials: J
authors.lastname: Qiu
authors.forename: Maua
authors.initials: M
authors.lastname: Herme
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Wickersham
authors.forename: Frederick L
authors.initials: FL
authors.lastname: Altice
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023801:Directly Observed Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006678:HIV; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011329:Prisoners; D011446:Prospective Studies; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents
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