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

August 14, 2019 updated by: Friends Research Institute, Inc.

A Randomized Controlled Trial and Cohort Study of HIV Testing and Linkage to Care Corrections

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

797

Phase

  • Not Applicable

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
    • Maryland
      • Baltimore, Maryland, United States
        • Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: On-site Rapid HIV Testing
On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.
Behavioral: 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.
No Intervention: Off-site Referral for HIV Testing
Off-site referral for rapid HIV testing at a community health center or HIV testing clinic
Experimental: 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.
Behavioral: 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.
No Intervention: Treatment as Usual
Passive referral to HIV community treatment provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Willing to Undergo Rapid HIV Testing
Time Frame: Baseline

Aim 1: To determine the willingness of the community corrections population to undergo HIV testing (Seek).

Aim 1a: To compare a strategy of rapid HIV testing on site in community corrections (probation and parole offices) to referral to an off site community HIV testing location with a randomized control study (Test).
Baseline
Number of Participants That Entered Community HIV Treatment
Time Frame: 3-months
Number of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period.
3-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in Community HIV Treatment
Time Frame: 18 months
Number of Days with Retention in Community HIV Treatment
18 months
Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable
Time Frame: 6,12,18-months
To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections.
6,12,18-months

Collaborators and Investigators

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

Sponsor

Friends Research Institute, Inc.

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Michael S Gordon, D.P.A., Friends Research Institute, Inc.
  • Principal Investigator: Josiah D Rich, M.D., Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2011

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimate)

June 6, 2011

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01DA030771-01 (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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