NCT01366495

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
797

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

June 3, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

5.3 years

First QC Date

June 1, 2011

Results QC Date

March 1, 2019

Last Update Submit

August 14, 2019

Conditions

HIV

Keywords

SeekTestTreat

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Retention in Community HIV Treatment

    18 months

  • Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable

    6,12,18-months

Study Arms (4)

On-site Rapid HIV Testing

EXPERIMENTAL

On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office.

Behavioral: Project Bridge

Off-site Referral for HIV Testing

NO INTERVENTION

Off-site referral for rapid HIV testing at a community health center or HIV testing clinic

Project Bridge

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

Passive referral to HIV community treatment provider.

Interventions

Project BridgeBEHAVIORAL

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.

On-site Rapid HIV TestingProject Bridge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Baltimore, Maryland, United States

Location

Related Publications (2)

  • 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.

    PMID: 33492021DERIVED

  • 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.

    PMID: 23536140DERIVED

Results Point of Contact

Title
Dr. Michael S. Gordon, Senior Research Scientist
Organization
Friends Research Institute
mgordon@friendsresearch.org
410-837-3977

Study Officials

  • Michael S Gordon, D.P.A.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

  • Josiah D Rich, M.D.

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 6, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 21, 2019

Results First Posted

June 3, 2019

Record last verified: 2019-08

Locations

US(1)