NCT06477588 · University of Chicago
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)
What this study is about
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.
View original scientific description
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.
Interventions
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
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.
Primary outcome measures
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
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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- be at least 18 years of age;
- currently reside or intend to reside in one of the study communities (i.e., Cook County, Baton Rouge, and the New Orleans area);
- be able to provide informed consent in English and complete the study in English. In addition, potential participants must:
- 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;
- report needing employment-related services; and
- 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
- unwilling/unable to provide informed consent,
- does not live or intend to live in one of the study locations,
- unable to confirm HIV status,
- unable to conduct the study in English, and
- currently enrolled in another intervention to support HIV care, PrEP care, and economic stability.
Where
- Chicago, Illinois
Collaborators
Northwestern University, NORC at the University of Chicago, Frontline Legal Services, Capitol Area Reentry Program Inc., National Institute of Mental Health (NIMH), Cook County Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations