A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections
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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 |
- 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).
- 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: | April 2014 (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 |
Inclusion Criteria:
- Probation or Parole;
- Resident of Baltimore, MD or Providence, RI; 3) Willing to be tested for HIV
Contacts and Locations| Contact: Micahel S Gordon, D.P.A. | 410-837-3977 ext 251 | mgordon@friendsresearch.org |
| United States, Maryland | |
| Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation | Recruiting |
| Baltimore, Maryland, United States | |
| United States, Rhode Island | |
| Rhode Island Department of Corrections, Office of Adult Probation and Parole | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| 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
| 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: | November 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Friends Research Institute, Inc.:
|
Seek Test Treat |
ClinicalTrials.gov processed this record on June 18, 2013