Recruiting

MEPS

Sponsor:

UCLA

Code:

NCT07433985

Conditions

HIV Prevention

Sexually Transmitted Infections (STI)

Preexposure Prophylaxis (PrEP)

Incarceration

Hepatitis C Virus (HCV)

Eligibility Criteria

Sex: Male

Age: 18 - 59

Healthy Volunteers: Accepted

Interventions

Mobile Enhanced Prevention Support (MEPS)

Control

Study Details

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

HIV Prevention

Sexually Transmitted Infections (STI)

Preexposure Prophylaxis (PrEP)

Incarceration

Hepatitis C Virus (HCV)

Study ID

NCT07433985

Start date

Dec 1, 2025

Status verified date

Mar, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 59

Healthy Volunteers: Accepted

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 counties, California).
  • Willing to provide informed consent for participation.

Exclusion Criteria:

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

Study Design

Enrollment

318 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: MEPS Arm

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.

active comparator: Control Arm

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

Interventions

Mobile Enhanced Prevention Support (MEPS)

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.

Control

Client-centered goal planning session plus usual care

Primary outcome measure

  • Initiate PrEP regimen [ Time Frame: 6 and 12 months ]
  • Demonstrate adherence to PrEP [ Time Frame: 6 and 12 months ]
  • Remain on PrEP for at least 3 months [ Time Frame: 6 and 12 months ]
  • Report an HIV test within 6 months of a follow-up interview [ Time Frame: 6 and 12 months ]
  • Report a test for HCV [ Time Frame: 6 and 12 months ]
  • Engage in substance use treatment in the community [ Time Frame: 6 and 12 months ]
  • Reduce substance use [ Time Frame: 6 and 12 months ]

Central Contacts and Locations

Central contacts

Study Director

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

Locations

CAL-PEP

Recruiting

Oakland, California, United States, 94608

Contacts

Lisa Ryan

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

Kindful Restoration

Recruiting

Riverside, California, United States, 92504

Contacts

Ernesto Rodriguez

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

Starting Over, Inc

Recruiting

Riverside, California, United States, 92506

Contacts

Ashley Williams

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

More Information

Sponsor

University of California, Los Angeles

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-04-03.