| NCT ID | NCT07433985 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | HIV Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 318 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2029-07-31 |
Trial Parameters
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Brief Summary
The California Hub for HIV/SUD Prevention Research with Reentry Populations addresses the question: "Can the evidence-based MEPS intervention be adapted and implemented at a range of organizations to effectively serve a wider range of clients?" The Mobile Enhanced Prevention Support (MEPS) intervention was originally implemented in Los Angeles County and was proven successful in promoting biomedical HIV prevention (PrEP) uptake and preventative screenings in people who used drugs who recently left incarceration. MEPS is an evidence-based intervention for people with substance use disorders (SUD) that incorporates a client-centered planning session, including trained peer mentors, service utilization incentives, and a mobile application (GeoPass). The study includes a randomized controlled trial (RCT) across three community partners located in Riverside and Alameda Counties. At least 300 people will be enrolled in these three counties; the first 200 will be randomized to either receive the intervention or usual care, with the final 100 all receiving the intervention. The primary implementation outcome for the study involves using an implementation science framework and assessment tools to examine MEPS's implementation. Key outcomes include how well the implementation strategies used support intervention enrollment and retention, integration with existing services in each partnering community agency, and perceived intervention acceptability, feasibility, appropriateness, and maintenance at 6- and 12-months. The primary effectiveness outcome for the study is an increase in HIV testing, PrEP uptake and adherence, and SUD service utilization at 6 months and 12 months in the MEPS compared to the usual care group. Secondary effectiveness outcomes include frequency of service use for SUDs, hepatitis C virus testing, and linkage to care for those who test positive for HIV or hepatitis C.
Eligibility Criteria
Inclusion Criteria: RCT Participants * Assigned male at birth * Ages 18 - 59 * Was released from incarceration in the previous 12 months (incarceration is defined as a stay in jail, prison, or detention centers for over 24 hours) * Reports an SUD diagnosis or seeking SUD services at any time in the 24 months prior to enrollment * During the 24 months prior to enrollment, either: 1. Reports intercourse with a person assigned male at birth 2. Reports injection drug use * Has not received an HIV diagnosis (based on self-report) * Possesses a smartphone or plans to obtain one * Plans to reside within designated jurisdictions (counties) for the 9 months following enrollment CBO and agency staff participating in implementation surveys or interviews * \>=18 years of age * Employed at a study site or otherwise involved with intervention implementation and/or maintenance OR works at an agency in the counties where the study is taking place (Los Angeles, Riverside, San Bernardino, and Alameda co
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