Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Urban Health Study II

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by RTI International
Information provided by (Responsible Party):
RTI International Identifier:
First received: June 28, 2011
Last updated: November 5, 2014
Last verified: November 2014

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

Condition Intervention Phase
Behavioral: Standard Referral
Behavioral: Project Bridge
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Finding, Testing and Treating High-Risk Probationers and Parolees With HIV

Resource links provided by NLM:

Further study details as provided by RTI International:

Primary Outcome Measures:
  • Log10 viral load [ Time Frame: Every 3 months for 2 years ] [ Designated as safety issue: No ]
    Changes in viral load over time will be compared between the standard referral and Project Bridge Groups

Secondary Outcome Measures:
  • Engagement in HIV Care [ Time Frame: Every 3 months for 2 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Every 3 months for 2 years ] [ Designated as safety issue: No ]
    The proportion of participants initiating HAART will be compared between the standard referral and Project Bridge groups

Estimated Enrollment: 202
Study Start Date: August 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • already in care
  • unable to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01402466

Contact: Alex H Kral, PhD 415-848-1314

United States, California
RTI International Urban Health Program Recruiting
San Francisco, California, United States, 94104
Contact: Jennifer Lorvick, PhD    415-848-1315   
Sponsors and Collaborators
RTI International
Principal Investigator: Alex H Kral, PhD RTI International
  More Information

No publications provided

Responsible Party: RTI International Identifier: NCT01402466     History of Changes
Other Study ID Numbers: 12690
Study First Received: June 28, 2011
Last Updated: November 5, 2014
Health Authority: United States: Federal Government

Keywords provided by RTI International:
Drug users
criminal justice
HIV care
incarceration processed this record on March 03, 2015