Clinical trial NCT01366495: A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections
Official title: A Randomized Controlled Trial and Cohort Study of HIV Testing and Linkage to Care Corrections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Seek
Test
Treat
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-06-06
Enrollment: 797
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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).

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 criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Number of Participants Willing to Undergo Rapid HIV Testing
timeFrame: Baseline
measure: Number of Participants That Entered Community HIV Treatment
timeFrame: 3-months
Secondary outcomes:
measure: Retention in Community HIV Treatment
timeFrame: 18 months
measure: Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable
timeFrame: 6,12,18-months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Maryland Department of Public Safety and Correctional Services (DPSCS), Division of Parole and Probation
state: Maryland
Study officials:
affiliation: Friends Research Institute, Inc.
name: Michael S Gordon, D.P.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Josiah D Rich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crable EL, Blue TR, McKenzie M, Rich JD, Gordon MS. Effect of Case Management on HIV Outcomes for Community Corrections Population: Results of an 18-Month Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2021 May 1;87(1):755-762. doi: 10.1097/QAI.0000000000002624.
citation: Gordon MS, Kinlock TW, McKenzie M, Wilson ME, Rich JD. Rapid HIV testing for individuals on probation/parole: outcomes of an intervention trial. AIDS Behav. 2013 Jul;17(6):2022-30. doi: 10.1007/s10461-013-0456-6.