Urban Health Study II

This study has been completed.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

RTI International

ClinicalTrials.gov Identifier:

NCT01402466

First received: June 28, 2011

Last updated: March 25, 2016

Last verified: March 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

June 28, 2011

Last Updated Date

March 25, 2016

Start Date ^ICMJE

August 2011

Primary Completion Date

March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

Enrollment ^ICMJE

Completion Date

December 2014

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

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

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

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