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/design

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

SUBMITTER: Mullen BA 

PROVIDER: S-EPMC3047295 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature