Urban Health Study II

HIV Clinical Trial

Official title:

Finding, Testing and Treating High-Risk Probationers and Parolees With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402466
• Other study ID #: 12690
• Secondary ID: R01MH094090
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2011
• Last updated: March 25, 2016
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• Standard Referral
Participants randomized to this arm will be referred to local HIV care resources
• Project Bridge
Arm 2

Locations

Country	Name	City	State
United States	RTI International Urban Health Program	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Log10 viral load	Changes in viral load over time will be compared between the standard referral and Project Bridge Groups	Every 3 months for 2 years	No
Secondary	Engagement in HIV Care	The proportion of participants entering HIV care will be compared between the standard referral and Project Bridge groups	Every 3 months for 2 years	No
Secondary	Initiation of Highly Active Antiretroviral Therapy (HAART)	The proportion of participants initiating HAART will be compared between the standard referral and Project Bridge groups	Every 3 months for 2 years	No