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Directly Observed Therapy for Community-Released HIV+ Prisoners

NCT00786396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2014-08-20

No results posted yet for this study

Summary

The aim of this study is to develop effective interventions for HIV-infected prisoners who are released to the community. The intervention that we will study will be directly observed therapy (DAART/DOT) and we will compare this to the current standard of care that involves self-administered therapy (SAT). All subjects will get transitional case management and all subjects with a prior history of opiate dependence will be offered opiate substitution therapy (buprenorphine or methadone).

Hypotheses:

* At the end of six months those receiving DAART will have a higher level of adherence to HAART as compared to the SAT group.
* The DAART Intervention will result in subjects having lower viral loads and higher CD4 counts as compared to the SAT group.
* At the end of six months, the DAART group will have a lower rate of recidivism to jail/prison as compared to the SAT group.
* Over the year, the DAART group will be more likely to make repeated primary HIV care visits than the SAT group.

Conditions

Interventions

BEHAVIORAL

Directly administered antiretroviral therapy

Daily observation of subjects taking their HIV medications

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Frederick L Altice, MD · Yale University

  • Gerald Friedland, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00786396 on ClinicalTrials.gov