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
2 other identifiers
interventional
350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Aug 2024
Typical duration for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedStudy Start
First participant enrolled
August 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
April 21, 2026
April 1, 2026
3.9 years
June 21, 2024
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Linkage to HIV care
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
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
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 Outcomes (7)
Retention in HIV care
12 months
HIV viral suppression
Baseline through 12 months
Retention in PrEP care
12 months
Receipt of mental health services
Baseline through 180 days in community
Receipt of substance use services
Baseline through 180 days in community
- +2 more secondary outcomes
Other Outcomes (4)
Receipt of other HIV prevention services
Baseline through 12 months
Changes in employer and temporary staffing agency policies and practices
Baseline through 12 months
Changes in housing status
Baseline through 12 months
- +1 more other outcomes
Study Arms (2)
Health Navigation
ACTIVE COMPARATORReferrals to HIV, mental health, substance use, and other supportive services
Health Navigation, Employment Navigation plus Contingency Management Intervention
EXPERIMENTALReferrals 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
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Frontline Legal Servicescollaborator
- Capitol Area Reentry Program Inc.collaborator
- National Institute of Mental Health (NIMH)collaborator
- University of Chicagolead
- Northwestern Universitycollaborator
- NORC at the University of Chicagocollaborator
- Cook County Healthcollaborator
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Russell Brewer, DrPH
University of Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2024
First Posted
June 27, 2024
Study Start
August 13, 2024
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- 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.
- 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
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.