Overview

This trial is active, not recruiting.

Condition hiv
Treatment project bridge
Sponsor Friends Research Institute, Inc.
Collaborator National Institute on Drug Abuse (NIDA)
Start date April 2011
End date August 2016
Trial size 6240 participants
Trial identifier NCT01366495, R01 DA030771-01

Summary

The investigators propose to conduct both a randomized trial of HIV testing in community corrections, and a randomized trial of linkage to HIV care for people with HIV recruited through community corrections (probation and parole).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose screening
Arm
(Experimental)
Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.
project bridge
Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.

Primary Outcomes

Measure
HIV testing
time frame: Baseline

Secondary Outcomes

Measure
1) engagement in care
time frame: 12-months
retention in care
time frame: 18 months
proportion of those prescribed Highly Active Antiretroviral Therapy (HAART) who are undetectable
time frame: 6,12,18-months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Probation or Parole; 2. Resident of Baltimore, MD or Providence, RI; 3) Willing to be tested for HIV

Additional Information

Official title A Randomized Controlled Trial and Cohort Study of HIV Testing and Linkage to Care Corrections
Principal investigator Michael S Gordon, D.P.A.
Description The first study is a two-group randomized controlled trial in which 6,000 male and female probationers and parolees in Baltimore City, Maryland and Providence, Rhode Island will be randomly assigned to one of two treatment conditions: 1) On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office; or 2) Off-site referral for rapid HIV testing at a community health center or HIV testing clinic. Inclusion criteria will be: 1) Adult probationer/parolee; 2) not known to be HIV positive, and 3) resident of greater Baltimore or Providence throughout the study period. Exclusion criteria will be: 1) unable to give informed consent. The second study is a randomized trial, whereby all individuals identified at community corrections with HIV will be offered enrollment in a one-year intervention study to examine the ability to improve linkage into HIV care. Participants will be randomized to receive one of two conditions: 1) Project Bridge for one year, or 2) Treatment as Usual-referral to standard level of care. Moreover, those randomized to TAU will be given an opportunity to "crossover" to PB if they have failed to engage in treatment during the first three months. The rationale for choosing the two cities of Baltimore, MD and Providence, RI is due to the historically high rates of heroin addiction that is associated with multiple HIV-related risk behaviors in these two cities and a high likelihood of being on probation and/or parole. Furthermore, Maryland ranks 10th and Rhode Island ranks 4th in the nation in the number of probationers per 100,000 adult residents.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Friends Research Institute, Inc..