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
NCT Number: NCT06477588
Acronym: J-RISE
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: HIV|Contingency Management|Justice Involved Populations|Status Neutral Interventions
Interventions: BEHAVIORAL: Health Navigation|BEHAVIORAL: Health Navigation, Employment Navigation plus Contingency Management Intervention
Sponsor: University of Chicago
Collaborators: Northwestern University|NORC at the University of Chicago|Frontline Legal Services|Capitol Area Reentry Program|National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 350
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-11
Completion Date: 2028-06-30
Locations: University of Chicago, Chicago, Illinois, 60637, United States

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.

Primary Outcome Measures: 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|Employment, Number of employment seeking participants who self-report on surveys becoming employed, Baseline through 180 days in community
Secondary Outcome Measures: Retention in HIV care, Number of participants who attend two HIV care visits at least 90 days apart based on medical reports, 12 months|HIV viral suppression, Number of participants with an HIV viral load \< 200 copies/ml based on medical reports, 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, 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., 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., 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, 12 months
Other Outcome Measures: 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), 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., Baseline through 12 months