A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections

Friends Research Institute

Status: Completed

Conditions: HIV

Treatments: Behavioral: Project Bridge

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01366495

R01DA030771-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 797 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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797 participants in 4 patient groups

On-site Rapid HIV Testing

Experimental group

Description:

On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.

Treatment:

Behavioral: Project Bridge

Off-site Referral for HIV Testing

No Intervention group

Description:

Off-site referral for rapid HIV testing at a community health center or HIV testing clinic

Project Bridge

Experimental group

Description:

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.

Treatment:

Behavioral: Project Bridge

Treatment as Usual

No Intervention group

Description:

Passive referral to HIV community treatment provider.