Urban Health Study II

Phase 2

Completed

• Conditions: HIV
• Interventions: Behavioral: Standard Referral; Behavioral: Project Bridge

• Registration Number: NCT01402466
• Lead Sponsor: RTI International

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.

Study Timeline

• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Start: 2011-08
• Primary Completion: 2014-03
• Study Completion: 2014-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-25
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

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

Exclusion Criteria

• already in care
• unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Referral	Standard Referral	Participants randomized to this arm will be referred to local HIV care resources
Project Bridge	Project Bridge	Participants randomized to this arm will be given the Project Bridge intervention

Primary Outcome Measures

Name	Time	Method
Log10 viral load	Every 3 months for 2 years	Changes in viral load over time will be compared between the standard referral and Project Bridge Groups

Secondary Outcome Measures

Name	Time	Method
Engagement in HIV Care	Every 3 months for 2 years	The proportion of participants entering HIV care will be compared between the standard referral and Project Bridge groups
Initiation of Highly Active Antiretroviral Therapy (HAART)	Every 3 months for 2 years	The proportion of participants initiating HAART will be compared between the standard referral and Project Bridge groups

Trial Locations

Locations (1)

RTI International Urban Health Program; 🇺🇸 San Francisco, California, United States