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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366495
• Other study ID #: R01DA030771-01
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: August 2016

Study information

• Verified date: August 2019
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 797
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Probation or Parole;

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

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
United States	Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Retention in Community HIV Treatment	Number of Days with Retention in Community HIV Treatment	18 months
Secondary	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