Urban Health Study II

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

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

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Standard Referral; Behavioral: Project Bridge

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94104
      • RTI International Urban Health Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Referral; Participants randomized to this arm will be referred to local HIV care resources	Behavioral: Standard Referral; Participants randomized to this arm will be referred to local HIV care resources
Experimental: Project Bridge; Participants randomized to this arm will be given the Project Bridge intervention	Behavioral: Project Bridge; Arm 2

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Alex H Kral, PhD, RTI International

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 28, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (Estimate): July 26, 2011

Study Record Updates

• Last Update Posted (Estimate): March 28, 2016
• Last Update Submitted That Met QC Criteria: March 25, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: criminal justice; HAART; Drug users; incarceration; HIV care
• Other Study ID Numbers: 12690; R01MH094090 (U.S. NIH Grant/Contract)