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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Project Bridge


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Willing to Undergo Rapid HIV Testing | 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 | 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 | Number of Days with Retention in Community HIV Treatment | 18 months | 
| Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seek, Test, Treat