HIVJ-RISENCT06477588
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
A study testing Health Navigation and Health Navigation, Employment Navigation plus Contingency Management Intervention in people with HIV and Contingency Management, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Contingency Management, Justice Involved Populations
- What is being tested?
- Health Navigation and Health Navigation, Employment Navigation plus Contingency Management Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2024to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Jeannette Webb, 773-834-5795, jwebb9@bsd.uchicago.edu
Mainza Durrell, DrPH, 773-702-7589, mdurrell@bsd.uchicago.edu
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- HIV, Contingency Management, Justice Involved Populations, Status Neutral Interventions, Mental Health, Substance Use
- Being tested
- Health Navigation, Health Navigation, Employment Navigation plus Contingency Management Intervention
- Keywords
- HIV, Contingency management, Justice involved populations, Status neutral interventions, mental health, substance use, employment, PrEP
- Medical subject headings
- Psychological Well-Being, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health NavigationBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Navigation | Active comparator | Referrals to HIV, mental health, substance use, and other supportive services Receives: Behavioral: Health Navigation |
| Health Navigation, Employment Navigation plus Contingency Management Intervention | Experimental | 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. Receives: Behavioral: Health Navigation, Employment Navigation plus Contingency Management Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to HIV care
Number of participants who visit a provider for HIV care and receive a prescription based on medical reports
Measured: 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
Measured: 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
Measured: Baseline through 90 days in community
Secondary outcomes (7)
Retention in HIV care
Number of participants who attend two HIV care visits at least 90 days apart based on medical reports
Measured: 12 months
HIV viral suppression
Number of participants with an HIV viral load < 200 copies/ml based on medical reports
Measured: Baseline through 12 months
Retention in PrEP care
Number of participants with at least two PrEP care visits in a 12-month period based on medical reports
Measured: 12 months
Receipt of mental health services
Number of participants with a mental health service visit within 180 days based on referrals reported complete by interventionists.
Measured: Baseline through 180 days in community
Receipt of substance use services
Number of participants with a substance use visit within 180 days based on referrals reported complete by interventionists.
Measured: Baseline through 180 days in community
Employment
Number of employment seeking participants who self-report on surveys being employed
Measured: Baseline through 180 days in community
Sustained employment
Number of participants who self-report in surveys maintaining employment for at least 3 months within a 12-month period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start13 Aug 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Russell Brewer, DrPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477588
- Sponsor's protocol ID
- IRB23-1495
- Other IDs
- R01MH134262
- Acronym
- J-RISE
- Status last verified
- Apr 2026
- First submitted
- 21 Jun 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06477588
- Acronym / sponsor ID
- J-RISE / IRB23-1495
- Conditions
- HIV, Contingency Management, Justice Involved Populations, Status Neutral Interventions, Mental Health, Substance Use
- Keywords
- HIV, Contingency management, Justice involved populations, Status neutral interventions, mental health, substance use, employment, PrEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- 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
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Navigation | Active comparator | Behavioral: Health NavigationReferrals to HIV, mental health, substance use, and other supportive services |
| Health Navigation, Employment Navigation plus Contingency Management Intervention | Experimental | Behavioral: Health Navigation, Employment Navigation plus Contingency Management InterventionReferrals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health NavigationParticipants 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 | Behavioural | Health Navigation |
| Health Navigation, Employment Navigation plus Contingency Management InterventionParticipants 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. | Behavioural | Health Navigation, Employment Navigation plus Contingency Management Intervention |
Primary outcome
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
7 secondary outcomes
Retention in HIV care
Time frame: 12 months
HIV viral suppression
Time frame: Baseline through 12 months
Retention in PrEP care
Time frame: 12 months
Receipt of mental health services
Time frame: Baseline through 180 days in community
Receipt of substance use services
Time frame: Baseline through 180 days in community
Employment
Time frame: Baseline through 180 days in community
Sustained employment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Russell Brewer, DrPH principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Navigation and Health Navigation, Employment Navigation plus Contingency Management Intervention in people with HIV and Contingency Management, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeannette Webb (773-834-5795, jwebb9@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to HIV care (time frame: Baseline through 90 days in community). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.