title: Study design and participant characteristics of a randomized controlled trial of directly administered antiretroviral therapy in opioid treatment programs.
abstract: BACKGROUND
  HIV-infected drug users are at higher risk of non-adherence and poor treatment outcomes than HIV-infected non-drug users. Prior work from our group and others suggests that directly administered antiretroviral therapy (DAART) delivered in opioid treatment programs (OTPs) may increase rates of viral suppression.
  
  
  METHODS
  We are conducting a randomized trial comparing DAART to self-administered therapy (SAT) in 5 OTPs in Baltimore, Maryland. Participants and investigators are aware of treatment assignments. The DAART intervention is 12 months. The primary outcome is HIV RNA < 50 copies/mL at 3, 6, and 12 months. To assess persistence of any study arm differences that emerge during the active intervention, we are conducting an 18-month visit (6 months after the intervention concludes). We are collecting electronic adherence data for 2 months in both study arms. Of 457 individuals screened, a total of 107 participants were enrolled, with 56 and 51 randomly assigned to DAART and SAT, respectively. Participants were predominantly African American, approximately half were women, and the median age was 47 years. Active use of cocaine and other drugs was common at baseline. HIV disease stage was advanced in most participants. The median CD4 count at enrollment was 207 cells/mm3, 66 (62%) had a history of an AIDS-defining opportunistic condition, and 21 (20%) were antiretroviral naïve.
  
  
  CONCLUSIONS
  This paper describes the rationale, methods, and baseline characteristics of subjects enrolled in a randomized clinical trial comparing DAART to SAT in opioid treatment programs.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00279110.
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Bernadette Anna
authors.initials: BA
authors.lastname: Mullen
authors.forename: Katie
authors.initials: K
authors.lastname: Cook
authors.forename: Richard D
authors.initials: RD
authors.lastname: Moore
authors.forename: Cynthia
authors.initials: C
authors.lastname: Rand
authors.forename: Noya
authors.initials: N
authors.lastname: Galai
authors.forename: Mary E
authors.initials: ME
authors.lastname: McCaul
authors.forename: Sheldon
authors.initials: S
authors.lastname: Glass
authors.forename: Krisann K
authors.initials: KK
authors.lastname: Oursler
authors.forename: Gregory M
authors.initials: GM
authors.lastname: Lucas
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D015142:Baltimore; D035843:Biomedical Research / Q000379:methods*; D002986:Clinical Trials as Topic; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D012646:Self Administration; D019966:Substance-Related Disorders / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral