An interventional study of Health Navigation and Health Navigation, Employment Navigation plus Contingency Management Intervention in HIV, Contingency Management and Justice Involved Populations, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by University of Chicago · Not applicable, Interventional, and Other
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:
Participants on the study will be:
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.
971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.
This study's planned enrollment of 350 is above the median of 116 across 830 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
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Exclusion Criteria:
Referrals to HIV, mental health, substance use, and other supportive services
Behavioral: Health Navigation
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 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.
Linkage to HIV care
Number of participants who visit a provider for HIV care and receive a prescription based on medical reports
Time frame: 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
Time frame: 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
Time frame: Baseline through 90 days in community
Retention in HIV care
Number of participants who attend two HIV care visits at least 90 days apart based on medical reports
Time frame: 12 months
HIV viral suppression
Number of participants with an HIV viral load \< 200 copies/ml based on medical reports
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 180 days in community
Employment
Number of employment seeking participants who self-report on surveys being employed
Time frame: 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
Time frame: 12 months
Receipt of other HIV prevention services
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)
Time frame: Baseline through 12 months
Changes in employer and temporary staffing agency policies and practices
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.
Time frame: Baseline through 12 months
Changes in housing status
Number of participants who self-report stable housing
Time frame: Baseline through 12 months
Changes in substance use behaviors
Number of participants who self-report substance use behaviors
Time frame: Baseline through 12 months
Plan to share: 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.
Supporting information: Study protocol, Analytic code
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