Urban Health Study II

RTI International

Status and phase: Completed; Phase 2

Conditions: HIV

Treatments: Behavioral: Project Bridge; Behavioral: Standard Referral

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01402466

12690

R01MH094090 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• already in care
• unable to provide informed consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 2 patient groups

Standard Referral

Active Comparator group

Description:

Participants randomized to this arm will be referred to local HIV care resources

Treatment:

Behavioral: Standard Referral

Project Bridge

Experimental group

Description:

Participants randomized to this arm will be given the Project Bridge intervention

Treatment:

Behavioral: Project Bridge