Urban Health Study II

March 25, 2016 updated by: RTI International

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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
Every 3 months for 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every 3 months for 2 years
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
Every 3 months for 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI International

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Alex H Kral, PhD, RTI International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 12690
  • R01MH094090 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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