J-RISE: Relevant Implementation Strategies to Eliminate the Social and Structural Barriers to HIV… (NCT06477588) | Clinical Trial Compass
RecruitingNot Applicable
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
United States350 participantsStarted 2024-08-13
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Linkage to HIV care
Timeframe: Baseline through 90 days in community
2
Linkage to PrEP care
Timeframe: Baseline through 90 days in community
3
Linkage to employment-related services in community