Recruiting

Health Navigation & Health Navigation PlusJ-RISE: Relevant Implementation Strategies to Eliminate the Social and Structural Barriers to HIV Services Among Justice-involved Black Men Who Have Sex With Men and Other Key Populations

Sponsor:

University of Chicago

Code:

NCT06477588

Conditions

HIV

Contingency Management

Justice Involved Populations

Status Neutral Interventions

Mental Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Health Navigation

Health Navigation, Employment Navigation plus Contingency Management Intervention

Study Details

Brief summary:

The goal of this clinical trial is to compare two interventions - Health Navigation and Health Navigation Plus among individuals who have been impacted by the criminal legal system.

The main question it aims to answer is:

• Compared with the Health Navigation group, are participants in the Health Navigation Plus group more likely to a) access HIV care, treatment, and prevention services and employment services and b) access employment services and be employed in community?

Participants on the study will be:

Randomly assigned (like a flip of a coin) to participate in either Health Navigation or Health Navigation Plus. Participants will have an equal chance of being placed in either group.
Complete three surveys over the course of 13 months
Participants in the Health Navigation group will have two in person meetings and seven check-ins with the health navigator over 6 months
Participants in the Health Navigation Plus group will have two in person meetings and seven check-ins with the health navigator over 6 months, two in person and 10 check ins with the employment navigator over 12 months and up to $200 to support employment and career development needs and receive up to $140 to support health goals. Samples of blood, urine and swabs may be collected to meet the health goals.

Conditions

HIV

Contingency Management

Justice Involved Populations

Status Neutral Interventions

Mental Health

Study ID

NCT06477588

Start date

Aug 13, 2024

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. be at least 18 years of age;
2. currently reside or intend to reside in one of the study communities (i.e., Cook County, Baton Rouge, and the New Orleans area);
3. be able to provide informed consent in English and complete the study in English. In addition, potential participants must:
4. be currently incarcerated in jail or prison and report an expected release within 90 days, or under community supervision or drug court, or report a recent incarceration within the last three years, or in the last 12 months has had an interaction with law enforcement that did not lead to an arrest or jail or prison time, AND has not already been linked and/or retained in HIV or PrEP care in the community;
5. report needing employment-related services; and
6. have a confirmed HIV positive or negative status (within 90 days of enrollment) and if HIV negative meets one of CDC's PrEP indications (i.e., sexually active, needle sharing, previous STI history in the last 24 months) or plans to have sex in the next 12 months or wants more information about PrEP.

Exclusion Criteria:

1. unwilling/unable to provide informed consent,
2. does not live or intend to live in one of the study locations,
3. unable to confirm HIV status,
4. unable to conduct the study in English, and
5. currently enrolled in another intervention to support HIV care, PrEP care, and economic stability.

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Health Navigation

Referrals to HIV, mental health, substance use, and other supportive services

experimental: Health Navigation, Employment Navigation plus Contingency Management Intervention

Referrals to HIV, mental health, substance use, and other supportive services Referrals for employment including training, and career development needs; Provision of financial incentives for the uptake and achievement of specific HIV care and prevention milestones.

Interventions

Health Navigation

Participants meet with Health Navigator twice in-person and receive 7 check-ins from the Health Navigator over a 6 month period. The health navigator provides participants with referrals and support to HIV, mental health, substance use, and other supportive services

Health Navigation, Employment Navigation plus Contingency Management Intervention

Participants meet with health navigator twice in-person and receive 7 check-ins from the health navigator over a 6 month period. The health navigator provides participants with referrals and support to HIV, mental health, substance use, and other supportive services. Participants meeting with the employment navigator twice in-person and receive 10 check-ins from the employment navigator over 12 months. The employment navigator provides participants with referrals to employment and career development opportunities in the community and up to $200 for employment and career development support (e.g., transportation to interview, GED preparation course). Participants also receive up to $140 for HIV/STI care, treatment, and prevention milestones as part of the contingency management interview over a period of 12 months.

Primary outcome measure

Linkage to HIV care [ Time Frame: Baseline through 90 days in community ]
Linkage to PrEP care [ Time Frame: Baseline through 90 days in community ]
Linkage to employment-related services in community [ Time Frame: Baseline through 90 days in community ]

Central Contacts and Locations

Central contacts

Jeannette Webb

773-834-5795 jwebb9@bsd.uchicago.edu

Mainza Durrell, DrPH

773-702-7589 mdurrell@bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Jeannette Webb

773-834-5795 jwebb9@bsd.uchicago.edu

Mainza Durrell, DrPH

773-702-7589 mdurrell@bsd.uchicago.edu

Principal Investigator:

Russell Brewer, DrPH

More Information

Sponsor

University of Chicago

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

HIV
Contingency management
Justice involved populations
Status neutral interventions
mental health
substance use
employment
PrEP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-04-21.