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Urban Health Study II

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by RTI International
Sponsor:
Collaborator:
Information provided by (Responsible Party):
RTI International
ClinicalTrials.gov Identifier:
NCT01402466
First received: June 28, 2011
Last updated: November 5, 2014
Last verified: November 2014

June 28, 2011
November 5, 2014
August 2011
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01402466 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
HIV
  • Behavioral: Standard Referral
    Participants randomized to this arm will be referred to local HIV care resources
  • Behavioral: Project Bridge
    Arm 2
  • Active Comparator: Standard Referral
    Participants randomized to this arm will be referred to local HIV care resources
    Intervention: Behavioral: Standard Referral
  • Experimental: Project Bridge
    Participants randomized to this arm will be given the Project Bridge intervention
    Intervention: Behavioral: Project Bridge
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
202
June 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • already in care
  • unable to provide informed consent
Both
18 Years to 70 Years
No
Contact: Alex H Kral, PhD 415-848-1314 akral@rti.org
United States
 
NCT01402466
12690
No
RTI International
RTI International
National Institute of Mental Health (NIMH)
Principal Investigator: Alex H Kral, PhD RTI International
RTI International
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP