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Completed

NCT Number: NCT01366495

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

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation

Baltimore, Maryland, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Project Bridge

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Retention in Community HIV Treatment

    Time frame: 18 months

    Number of Days with Retention in Community HIV Treatment

  2. 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.

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2011
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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