Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Friends Research Institute, Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Gordon, Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01366495
First received: June 1, 2011
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention
HIV
Behavioral: Project Bridge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Randomized Controlled Trial and Cohort Study of HIV Testing and Linkage to Care Corrections

Resource links provided by NLM:


Further study details as provided by Friends Research Institute, Inc.:

Primary Outcome Measures:
  • HIV testing [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • 1) engagement in care [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    To determine whether people with HIV (both known and newly diagnosed) can be identified in community corrections. To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections.To determine the impact of PB versus TAU on individuals with HIV recruited through community corrections on: 1) engagement in care; 2) retention in care; and 3) proportion of those prescribed Highly Active Antiretroviral Therapy (HAART) who are undetectable at 6/12 months using a pre-post analysis (Treat).

  • retention in care [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    To determine the impact of Project Bridge (PB) versus Treatment as Usual (TAU) on individuals with HIV recruited through community corrections

  • proportion of those prescribed Highly Active Antiretroviral Therapy (HAART) who are undetectable [ Time Frame: 6,12,18-months ] [ Designated as safety issue: No ]
    To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections.


Estimated Enrollment: 6240
Study Start Date: April 2011
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Probation or Parole;
  2. Resident of Baltimore, MD or Providence, RI; 3) Willing to be tested for HIV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366495

Contacts
Contact: Micahel S Gordon, D.P.A. 410-837-3977 ext 251 mgordon@friendsresearch.org

Locations
United States, Maryland
Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation Recruiting
Baltimore, Maryland, United States
Sponsors and Collaborators
Friends Research Institute, Inc.
Investigators
Principal Investigator: Michael S Gordon, D.P.A. Friends Research Institute, Inc.
Principal Investigator: Josiah D Rich, M.D. Brown University
  More Information

No publications provided by Friends Research Institute, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Gordon, Principal Investigator, Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01366495     History of Changes
Other Study ID Numbers: R01 DA030771-01
Study First Received: June 1, 2011
Last Updated: September 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Friends Research Institute, Inc.:
Seek
Test
Treat

ClinicalTrials.gov processed this record on November 23, 2014