Urban Health Study II

Tracking Information
First Submitted Date ICMJE	June 28, 2011
First Posted Date ICMJE	July 26, 2011
Last Update Posted Date	March 28, 2016
Study Start Date ICMJE	August 2011
Actual Primary Completion Date	March 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 25, 2011)	Log10 viral load [ Time Frame: Every 3 months for 2 years ]; Changes in viral load over time will be compared between the standard referral and Project Bridge Groups
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01402466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 25, 2011)	Engagement in HIV Care [ Time Frame: 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) [ Time Frame: Every 3 months for 2 years ]The proportion of participants initiating HAART will be compared between the standard referral and Project Bridge groups
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Urban Health Study II
Official Title ICMJE	Finding, Testing and Treating High-Risk Probationers and Parolees With HIV
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 Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Health Services Research
Condition ICMJE	HIV
Intervention ICMJE	Behavioral: Standard Referral Participants randomized to this arm will be referred to local HIV care resources; Behavioral: Project Bridge Arm 2
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 6, 2015)	49
Original Estimated Enrollment ICMJE; (submitted: July 25, 2011)	202
Actual Study Completion Date	December 2014
Actual Primary Completion Date	March 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Age 18 or older; HIV antibody positive; not currently receiving HIV care Exclusion Criteria: already in care; unable to provide informed consent
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01402466
Other Study ID Numbers ICMJE	12690; R01MH094090 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	RTI International
Study Sponsor ICMJE	RTI International
Collaborators ICMJE	National Institute of Mental Health (NIMH)
Investigators ICMJE	Principal Investigator: Alex H Kral, PhD RTI International
PRS Account	RTI International
Verification Date	March 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP