California MEPS Hub

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-59
SponsorUniversity of California, Los Angeles

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Control

    Other intervention

    Client-centered goal planning session plus usual care

Treatment groups

318 Participants
are divided into 2 treatment groups
Group A: MEPS ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Initiate PrEP regimen

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

Time frame
6 and 12 months
2

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.

Time frame
6 and 12 months
3

Remain on PrEP for at least 3 months

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

Time frame
6 and 12 months
4

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

Time frame
6 and 12 months

Secondary outcomes

1

Receive care for newly diagnosed HCV or HIV

Defined as self-report of receiving follow-up care and treatment for any HIV or hepatitis C infections diagnosed during study follow-up

Time frame
6 and 12 months
2

Access services for overdose prevention and infectious disease control

Defined as self report of having obtained any harm reduction supplies such as naloxone, clean needles, test strips, or smoking supplies in the prior 6 months

Time frame
6 and 12 months
3

Recidivism

Measure the comparative effectiveness of the intervention on the proportion of participants who report any arrests in the prior 6 months

Time frame
6 and 12 months
4

Frequency of arrests among those who recividate

Measure the comparative effectiveness of the intervention in reducing recidivism, quantified as total number of arrests over the study period among those who are arrested at least once

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

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