Study design and participant characteristics of a randomized controlled trial of directly administered antiretroviral therapy in opioid treatment programs

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 na？ve.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.ClinicalTrials.gov: NCT00279110Founded on the successful model of directly observed therapy for tuberculosis [1], directly administered antiretroviral therapy (DAART) for HIV-infected individuals has been evaluated in several contexts [2-4]. To date, trials have yielded mixed results regarding the efficacy of DAART for increasing adherence and viral suppression rates compared to self-administered therapy (SAT). A meta-analysis of randomized trials found no benefit for DAART relative to SAT for viral load suppression [2]. In contrast, a second meta-analysis, which included both randomized and non-randomized comparative studies, found DAART to be statistically significantly associated with a higher likelihood of viral suppression and larg