Study design and participant characteristics of a randomized controlled trial of directly administered antiretroviral therapy in opioid treatment programs
2011

Study of Directly Administered Antiretroviral Therapy in Opioid Treatment Programs

Sample size: 107 publication Evidence: moderate

Author Information

Author(s): Mullen Bernadette Anna, Cook Katie, Moore Richard D, Rand Cynthia, Galai Noya, McCaul Mary E, Glass Sheldon, Oursler Krisann K, Lucas Gregory M

Primary Institution: Johns Hopkins University School of Medicine

Hypothesis

Providing directly administered antiretroviral therapy (DAART) to HIV-infected individuals in opioid treatment programs (OTPs) would be effective and sustainable.

Conclusion

The study describes the rationale, methods, and baseline characteristics of subjects enrolled in a trial comparing DAART to self-administered therapy (SAT) in opioid treatment programs.

Supporting Evidence

  • HIV-infected drug users are at higher risk of non-adherence and poor treatment outcomes than non-drug users.
  • The study enrolled 107 participants from 5 opioid treatment programs in Baltimore.
  • Participants had advanced HIV disease, with a median CD4 count of 207 cells/mm3.

Takeaway

This study is trying to see if giving HIV medicine directly to people in drug treatment programs helps them stick to their treatment better than if they take the medicine themselves.

Methodology

A randomized controlled trial comparing DAART to SAT in 5 opioid treatment programs in Baltimore, Maryland, with follow-up visits at 3, 6, 12, and 18 months.

Potential Biases

Potential bias due to the non-blinded nature of the trial and the specific eligibility criteria that may limit generalizability.

Limitations

The relatively small sample size limits the ability to detect small but potentially meaningful differences between study conditions.

Participant Demographics

Participants were predominantly African American, approximately half were women, and the median age was 47 years.

Digital Object Identifier (DOI)

10.1186/1471-2334-11-45

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