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Clinical Trials/NCT01402466
NCT01402466
Completed
Phase 2

Finding, Testing and Treating High-Risk Probationers and Parolees With HIV

RTI International1 site in 1 country49 target enrollmentAugust 2011
ConditionsHIV

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
HIV
Sponsor
RTI International
Enrollment
49
Locations
1
Primary Endpoint
Log10 viral load
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The study will test an intervention to help HIV-positive people achieve consistency of HIV care while transitioning in and out of jail.

Detailed Description

The study has two research objectives: (1) to expand access and options for HIV testing with individuals in the criminal justice system, by focusing on high-risk intravenous drug users (IDUs) and crack cocaine smokers in community settings; and (2) to improve access and maintenance of highly active antiretroviral treatment (HAART) among HIV-positive persons in this population, by implementing a promising intervention focused on continuity of HIV care, and evaluating it using a rigorous experimental design. HIV-positive persons will be identified through the testing activities described in Objective 1. They will then be offered enrollment in a randomized controlled trial (RCT) of an intervention designed to engage and maintain HIV-positive people with criminal justice involvement in medical care. The intervention, Project Bridge, has shown great promise but has not yet been rigorously evaluated. The RCT will assess the efficacy of Project Bridge compared with a Usual Care arm. Our hypotheses are that, at quarterly data collection visits: (1) Intervention participants will have lower HIV viral load than usual care participants 2b: (2) Intervention participants will be more likely to be in HIV care than usual care participants (3) Intervention participants will be more likely to be on HAART than usual care participants. The study design was changed from a randomized controlled trial to a quasi-experimental comparison group design. This change was approved by the NIMH Program Officer and the RTI IRB in June, 2012.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
December 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older
  • HIV antibody positive
  • not currently receiving HIV care

Exclusion Criteria

  • already in care
  • unable to provide informed consent

Outcomes

Primary Outcomes

Log10 viral load

Time Frame: Every 3 months for 2 years

Changes in viral load over time will be compared between the standard referral and Project Bridge Groups

Secondary Outcomes

  • Engagement in HIV Care(Every 3 months for 2 years)
  • Initiation of Highly Active Antiretroviral Therapy (HAART)(Every 3 months for 2 years)

Study Sites (1)

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