Directly Observed Antiretroviral Therapy Among Active Drug Users
Condition: HIV/AIDS; Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The goal of this randomized, controlled trial is to compare the effectiveness of a
      community-based program of providing supervised antiretroviral therapy to HIV-positive drug
      users, compared to having the patients take the medicines on their own.
    

Detailed description: 
      Highly active antiretroviral therapy (HAART) has dramatically reduced morbidity and mortality
      from HIV disease, but these benefits have not been conferred equally among all patient
      populations. Injection drug users (IDUs) have shown particularly less favorable outcomes,
      with HIV progression remaining at high levels, and IDU remains a significant risk behavior
      for the spread of HIV worldwide, with explosive epidemics in Eastern Europe, Russia, and
      Southeast Asia. It is therefore essential to develop and test strategies of HIV treatment
      that optimize outcomes for this population, in order to reduce morbidity and mortality and to
      curb secondary transmission.

      Directly observed therapy (DOT) for tuberculosis has resulted in impressive improvements in
      adherence and clinical response and marked reductions in the development of resistance. The
      time-limited treatment of tuberculosis, the inherently different transmission patterns of
      tuberculosis and HIV, and the complexity of antiretroviral therapy have raised concerns about
      translating the DOT model to HIV. Successful, but non-comparative demonstration programs of
      directly administered antiretroviral therapy (DAART) have been implemented in methadone
      maintenance programs, community-based settings, skilled nursing facilities, and in prisons.
      None of these, however, have targeted active drug users or used a prospective, randomized
      controlled trial (RCT) design to rigorously determine the efficacy of DAART as an
      intervention to improve HIV outcomes among active drug users. One RCT of DAART recently
      failed to demonstrate an impact on virological outcomes among low-income HIV+ patients, but
      these results are unlikely to be applicable to IDUs or other populations with demonstrated
      problematic adherence.

      We therefore conducted the first randomized controlled trial to address this question,
      consisting of six months of DAART versus self-administered therapy (SAT) among active drug
      users in a community setting. The objective was to determine the potential efficacy of a
      six-month DAART program on HIV infection, using surrogate markers of HIV- RNA levels and CD4+
      T lymphocyte counts.
    

Intervention name(s): Directly Administered Antiretroviral Therapy
Intervention type(s): Behavioral
Intervention MeSH terms: Anti-Retroviral Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: human immunodeficiency virus; acquired immunodeficiency syndrome; substance abuse; directly administered antiretroviral therapy; adherence, directly observed therapy