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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Mobile Enhanced Prevention Support (MEPS)
BehavioralThe 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 interventionClient-centered goal planning session plus usual care
Treatment groups
Trial outcomes
Primary outcomes
Initiate PrEP regimen
Defined as the participant obtaining a prescription for PrEP and self-reporting taking the medication
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.
Remain on PrEP for at least 3 months
Defined by self-reported PrEP use for 3 or more 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
Secondary outcomes
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
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
Recidivism
Measure the comparative effectiveness of the intervention on the proportion of participants who report any arrests in the prior 6 months
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
Sponsors and contacts
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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