J-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 (J-RISE)

April 17, 2026 updated by: University of Chicago

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The overarching goals of J-RISE is to evaluate the effectiveness and implementation of two packaged status neutral interventions to improve access to HIV and employment-related services and employment among individuals who have been impacted by the criminal legal system. Criminal legal involved individuals are particularly vulnerable to HIV, and oftentimes experience delayed uptake and benefit from available HIV services. Status neutral interventions for criminal legal involved individuals hold significant promise in supporting Ending the HIV Epidemic (EHE) plans including enhancing access to HIV, mental health, and substance use services post-release; expanding the skills of the HIV workforce; and addressing the social and structural barriers to HIV services (e.g., unemployment) experienced by this population. The underlying tenet of status neutral interventions is a holistic or whole person approach to service delivery that meets the needs of clients regardless of their HIV status. There is a dearth of implementation science research in this domain, generally, and specifically for criminal legal involved individuals. The following status neutral evidenced-informed/promising interventions will be implemented to improve HIV, pre-exposure prophylaxis (PrEP), and employment-related outcomes: (1) Health Navigation (HN) - leading with status neutral health navigator, a foundational intervention, to enhance access to HIV, mental health, substance use, and other supportive services; followed by (2) Employment navigation (EN) -status neutral employment navigators dedicated to supporting client employment, training, and career development needs; and coupled with (3) Contingency Management Intervention (CMI) - the provision of financial incentives for the uptake and achievement of specific HIV care and prevention milestones. Bringing these interventions together will maximize their independent effectiveness and provide significant promise for addressing the social and structural barriers to HIV services. J-RISE will be guided by robust implementation science and equity frameworks (i.e., CFIR: Consolidated Framework for Implementation Research, RE-AIM: Reach Effectiveness Adoption Implementation Maintenance, and MIPA: Meaningful Involvement of People Living with and Impacted by HIV) and tools (e.g., implementation outcomes crosswalk and implementation research logic model). The implementation evaluation will study seven proposed implementation strategies: (1) Building a cross-site learning collaborative; (2) conducting readiness assessments; (3) providing cross-site training for the status-neutral interventions; (4) facilitating ongoing calls with interventionists; (5) monitoring financial incentives; (6) conducting audit and feedback to support implementation; and (7) engaging clients and consumers in the intervention.

Study Aim:

Aim 1. Evaluate the effectiveness of two packaged status neutral interventions (Health Navigation versus Health Navigation + Employment Navigation + Contingency Management Intervention) on primary outcomes (i.e., linkages to HIV, PrEP, and employment-related services within 90 days) and secondary outcomes (i.e., receipt of HIV/STI testing, receipt of mental health and substance use services, retention in HIV and PrEP care, viral suppression, employment within 180 days and sustained employment) among enrolled participants. The investigators will conduct a pragmatic 2-arm randomized control trial (RCT) with N=350 enrolled participants randomized 1:1.

Aim 2. Explore the deployment of seven prioritized implementation strategies to enhance the adoption, implementation, and sustainment of the packaged status neutral interventions as it relates to nine key implementation outcomes (i.e., reach, acceptability, feasibility, adoption, fidelity, penetration, effectiveness, cost, engagement, and sustainability). The investigators will utilize a mixed method approach to complete this aim.

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
        • Contact:
        • Principal Investigator:
          • Russell Brewer, DrPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Health Navigation
Referrals to HIV, mental health, substance use, and other supportive services
Behavioral: 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
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linkage to HIV care
Time Frame: Baseline through 90 days in community
Number of participants who visit a provider for HIV care and receive a prescription based on medical reports
Baseline through 90 days in community
Linkage to PrEP care
Time Frame: Baseline through 90 days in community
Number of participants who visit a provider for PrEP care ranging from PrEP information only to the receipt of a prescription based on medical reports
Baseline through 90 days in community
Linkage to employment-related services in community
Time Frame: Baseline through 90 days in community
Number of referred participants who receive employment-related service in the community based on referral reports completed by the interventionists
Baseline through 90 days in community

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in HIV care
Time Frame: 12 months
Number of participants who attend two HIV care visits at least 90 days apart based on medical reports
12 months
HIV viral suppression
Time Frame: Baseline through 12 months
Number of participants with an HIV viral load < 200 copies/ml based on medical reports
Baseline through 12 months
Retention in PrEP care
Time Frame: 12 months
Number of participants with at least two PrEP care visits in a 12-month period based on medical reports
12 months
Receipt of mental health services
Time Frame: Baseline through 180 days in community
Number of participants with a mental health service visit within 180 days based on referrals reported complete by interventionists.
Baseline through 180 days in community
Receipt of substance use services
Time Frame: Baseline through 180 days in community
Number of participants with a substance use visit within 180 days based on referrals reported complete by interventionists.
Baseline through 180 days in community
Sustained employment
Time Frame: 12 months
Number of participants who self-report in surveys maintaining employment for at least 3 months within a 12-month period
12 months
Employment
Time Frame: Baseline through 180 days in community
Number of employment seeking participants who self-report on surveys being employed
Baseline through 180 days in community

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of other HIV prevention services
Time Frame: Baseline through 12 months
Number of participants who self-report in surveys receiving a HIV/STI Test, nonoccupational HIV post-exposure prophylaxis (nPEP), and/or Doxycycline post-exposure prophylaxis (DoxyPEP)
Baseline through 12 months
Changes in employer and temporary staffing agency policies and practices
Time Frame: Baseline through 12 months
Number and types of observed policies and practices related to hiring returned citizens over the course of the study based on email correspondence and informal conversations with employers and temporary staffing agencies.
Baseline through 12 months
Changes in housing status
Time Frame: Baseline through 12 months
Number of participants who self-report stable housing
Baseline through 12 months
Changes in substance use behaviors
Time Frame: Baseline through 12 months
Number of participants who self-report substance use behaviors
Baseline through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute of Mental Health (NIMH)
Northwestern University
NORC at the University of Chicago
Cook County Health
Frontline Legal Services
Capitol Area Reentry Program Inc.

Investigators

  • Principal Investigator: Russell Brewer, DrPH, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 21, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB23-1495
  • R01MH134262 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The J-RISE project will share individual level data of common data elements, with identifiers removed, with the SISCI coordinating center. Definitions and codebooks for all common data elements will be provided by the SISCI coordinating center, along with standardized survey items and qualitative questions where possible. All data submitted to the SISCI coordinating center will be deposited to Northwestern University's ARCH repository at the end of the performance period; de-identified survey data will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). De-identified data will be shared with outside entities at the end of the study upon publication of the planned protocol and primary outcomes papers.

IPD Sharing Time Frame

Data will be shared biannually on July 15 and December 1 from 2024-2028. All data submitted to the SISCI coordinating center will be deposited to Northwestern University's ARCH repository at the end of the performance period; de-identified survey data will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). De-identified data will be shared with outside entities at the end of the study upon publication of the planned protocol and primary outcomes papers.

IPD Sharing Access Criteria

Any investigator may propose research questions and manuscript ideas. For external investigators, the SISCI coordinating center will determine whether a data use agreement is needed that will regulate sharing of de-identified data. PIs will be able to opt in to data sharing on a case-by-case basis upon reviewing the proposal. Through this mechanism, the University of Chicago will make data available to users under data sharing agreements that meet the following criteria:

  • A commitment to using the data only for research purposes and not to identify any individual participant
  • A commitment to securing the data using appropriate transfer and storage protections
  • A commitment to destroying or returning the data after analyses are completed
  • A commitment to acknowledging the source (i.e. parent study) of the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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