California MEPS Hub

NCT07433985 | Recruiting

• 2 other identifiers: 24-06654R33DA060626-02
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 3

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.

Conditions

Substance Use Disorder (SUD); HIV Prevention; Sexually Transmitted Infections (STI); Preexposure Prophylaxis (PrEP); Incarceration; Hepatitis C Virus (HCV)

Keywords

implementation science; contingency management; mobile health technology (mHealth); community based participatory research; type 3 hybrid implementation effectiveness trial; randomized controlled trial

Outcome Measures

Primary Outcomes (7)

• Initiate PrEP regimen

  Defined as the participant obtaining a prescription for PrEP and self-reporting taking the medication

  6 and 12 months

• Demonstrate adherence to PrEP

  Defined as the participant self-reporting taking prescribed PrEP in the previous 3 days. Assessed with a urine test kit that detects the presence of tenofovir disoproxil fumarate.

  6 and 12 months

• Remain on PrEP for at least 3 months

  Defined by self-reported PrEP use for 3 or more months

  6 and 12 months

• Report an HIV test within 6 months of a follow-up interview

  Defined as the participant self-reporting having obtained HIV testing within 3 months of the follow-up

  6 and 12 months

• Report a test for HCV

  Defined as the participant self-reporting having obtained HIV testing within 3 months of the follow-up

  6 and 12 months

• Engage in substance use treatment in the community

  Defined by the participant self-reporting remaining engaged in treatment (i.e., continuing to attend meetings, counseling or other treatment activities) in the 3 months prior to follow-up interviews.

  6 and 12 months

• Reduce substance use

  Defined as a reduction in problematic use based Texas Christian University (TCU) Drug Screen 5 for any substance identified at as a problem based on their baseline TCU 5 score

  6 and 12 months

Secondary Outcomes (4)

• Receive care for newly diagnosed HCV or HIV

  6 and 12 months

• Access services for overdose prevention and infectious disease control

  6 and 12 months

• Recidivism

  6 and 12 months

• Frequency of arrests among those who recividate

  12 months

Study Arms (2)

MEPS Arm

EXPERIMENTAL

Intervention arm participants receive a client-centered goal planning session following enrollment; 14 sessions with a peer mentor over a period of 6 months; cash incentives for accessing medical and non-medical services; and a smartphone app to keep track of goals, incentive earnings and provider appointments, a provider search feature, and fill-out surveys based on participant experiences with accessing services.

Behavioral: Mobile Enhanced Prevention Support (MEPS)

Control Arm

ACTIVE COMPARATOR

Control arm participants receive a client-centered goal planning session (like the intervention arm), and usual care.

Other: Control

Interventions

Mobile Enhanced Prevention Support (MEPS) BEHAVIORAL

The 6 month MEPS intervention consists of 14 sessions with a peer mentor over a period of 6 months; up to $600 cash incentives for accessing medical and non-medical services while working the the peer mentor; and a smartphone app to keep track of goals, incentive earnings and provider appointments, a provider search feature, and fill out surveys based on participant experiences with services.

MEPS Arm

Control OTHER

Client-centered goal planning session plus usual care

Control Arm

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Reports intercourse with a person assigned male at birth
• 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 counties, California).
• Willing to provide informed consent for participation.

You may not qualify if:

• RCT Participants:
• Does not have a smart phone and is not willing to obtain one
• Is not able to speak and understand English
• Has insufficient reading skills to operate a mobile application on a cell phone
• CBO participating in implementation interviews
• \- n/a

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of California, Berkeley: collaborator
• Charles Drew University of Medicine and Science: collaborator
• Starting Over, Inc: collaborator
• Kindful Restoration: collaborator
• CAL-PEP: collaborator

Study Sites (3)

CAL-PEP

Oakland, California, 94608, United States

RECRUITING

Kindful Restoration

Riverside, California, 92504, United States

RECRUITING

Starting Over, Inc

Riverside, California, 92506, United States

RECRUITING

Related Links

• Main study website. Information on data access to be added at a later date.

MeSH Terms

Conditions

Sexually Transmitted Diseases; Hepatitis C; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Study Director

CONTACT

424-501-4829; camepshub@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a randomized-controlled trial with parallel assignment. There's also a single-arm continuation: the final 100 enrolled participants (201-300) will all receive the intervention.

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 25, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Scientific data on which published manuscripts are based will be available at the time of their publication; all other generated scientific data will be shared no later than three years following the end of the award. Under the current repository policies, data will be preserved and available for the wider research community in perpetuity
• Access Criteria: The de-identified data and metadata will be submitted to the National Addiction \& HIV Data Archive Program hosted by the ICPSR (Inter-university Consortium for Political and Social Research). Data will be provided under a restricted data use agreement to users who demonstrate a valid research need and meet conditions of use. Maintenance of, and approval of access to a restricted-use file is managed by archive staff, and access to restricted-use files is offered to approved researchers under a set of highly controlled conditions.

Locations

US (3)