Ignite Creation Date:
2024-07-17 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06477588
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief 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
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
J-RISE
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
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 criminal legal involved Black men who have sex with men BMSM Criminal legal involved BMSM are particularly vulnerable to HIV and oftentimes experience delayed uptake and benefit from available HIV services Status neutral interventions for criminal legal involved BMSM 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 eg 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 BMSM In September 2023 in addition to BMSM community partners have prioritized Black transgendergender non-conforming individuals and Black cisgender women who have sex with men as key populations for inclusion in J-RISE Thus J-RISE will be expanded to include these populations The following status neutral evidenced-informedpromising 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 for key populations that are highly impacted by HIV J-RISE will be guided by robust implementation science and equity frameworks ie 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 eg 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 ie linkages to HIV PrEP and employment-related services within 90 days and secondary outcomes ie receipt of HIVSTI 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 N350 enrolled participants randomized 11
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 ie reach acceptability feasibility adoption fidelity penetration effectiveness cost engagement and sustainability The investigators will utilize a mixed method approach to complete this aim
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 ie linkages to HIV PrEP and employment-related services within 90 days and secondary outcomes ie receipt of HIVSTI 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 N350 enrolled participants randomized 11
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 ie reach acceptability feasibility adoption fidelity penetration effectiveness cost engagement and sustainability The investigators will utilize a mixed method approach to complete this aim
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH134262 | NIH | None | None |