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.

The Mobile Enhanced Prevention Support (MEPS) intervention combines three evidence-based components - peer support, a smartphone app (GeoPass), and contingency management in the form of small cash incentives for access services. The overarching goal of this study is to adapt the MEPS to ensure it can achieve its intended objectives for a diverse set of beneficiaries in wider settings and to establish both the tools and an audience for its dissemination. This will include a clinical trial and documentation and dissemination of tailoring and evaluation results. Our prior RCT of the MEPS intervention has shown it to be effective at increasing PrEP uptake and HIV testing among English-speaking participants in Los Angeles County. Now, the primary goal of our Type 3 Hybrid Implementation-Effectiveness study is to examine the MEPS implementation in different settings with a greater reach into the population who could benefit, with assessing effectiveness being a secondary goal. It is essential to consider inter-agency differences and their impact in this study.

For the randomized controlled trial, the investigators aim for a sample size of 300 participants across our 3 different study sites. The first 200 individuals enrolled with be randomized to either receive the intervention or be control participants. The last 100 individuals will all receive the intervention as a single arm continuation. Additionally, investigators will recruit 15 CBO partner staff (5 per agency), plus 6 individuals who work at agencies located in the same jurisdictions as the CBO partner staff. Both the CBO partner staff and agency representatives will be asked to participate in surveys and interviews at different time points during the R33 phase.

Client-centered Planning Session/Control Arm All participants, regardless of study arm, will receive the usual care services at the partner agency plus a client-centered planning session following enrollment. This session will be conducted with the person providing clinical supervision to the Peer Mentors at each site and may be conducted by phone, video, or in person. Plans, listing participant goals and tailored referrals, will be offered to the participant in electronic and paper versions. (For MEPS intervention participants, it will also be incorporated into the GeoPass app.)

Follow-up Quantitative Survey UCLA research associates (RAs) will conduct follow-up interviews with RCT participants at 6 and 12 months-post-enrollment. Investigators will use a survey instrument largely consisting of questions developed by the Common Data Element (CDE) workgroup comprised of NIDA CONNECT Network members; this study is one of the funded projects in CONNECT. Some of the survey questions were also carried forward from the original MEPS survey. The survey has the dual purpose of collecting information for the study aims as well as for each participant's needs assessment. The survey includes a comprehensive set of domains using validated measures/scales. Surveys administered at 6 and 12 months will include a set of questions designed to assess perceptions of the intervention (RE-AIM domains: adoption, implementation, and maintenance).

PrEP Adherence Assessment Participants who initiate PrEP (using an estimate derived from the prior MEPS trial, where up to 40% of participants will initiate PrEP) will be asked to choose to provide urine samples at six and 12 months for confirmation of PrEP use and evaluation of PrEP adherence through detection of tenofovir- (TFV, RE-AIM domain: adoption). Collection will be undertaken by partner community-based organization (CBO) agency staff.

Client-centered Planning Session/Intervention Arm (MEPS Overview) Participants enrolling in the study following randomization to the intervention arm will receive the usual care services at the partner agency, the client-centered planning session, plus the MEPS intervention is a 6-month, evidence-based intervention to increase engagement in SUD treatment, harm reduction, and preventive behaviors (including PrEP and PEP uptake and screening for HIV, STIs and HCV). MEPS includes Peer Mentor support, in combination with incentives and the GeoPass application, to facilitate effective goal-setting and tracking of client-centered plans and utilization of services, especially those for HIV/STI/HCV prevention and treatment for SUDs.

The site's clinical supervisor will match a Peer Mentor to each intervention participant, who then works with participants over 14 sessions to address the personal priorities and preventive health needs outlined in the participant's goal planning session. The intervention will also employ the systematic use of incentives to motivate specifically desired behaviors, borrowing elements from a practice known as contingency management (CM) to incentivize a range of activities, including meeting with the peer mentor and screening for STIs and hepatitis C, engaging in activities that fall along the PrEP cascade, and accessing social services, to name some examples (see list of incentives under "financial considerations" section below). Finally, the MEPS intervention will include a smartphone app, called GeoPass, which enables participants to find providers near them, track calendar appointments for planned service utilization, take experience surveys once services are utilized, track progress toward their wellness goals, and view incentive earnings. This project expands the MEPS target population to include cisgender men with a history of injection drug use (IDU) regardless of sexual orientation.

Follow-up In-depth Interview (IDI) Study staff will conduct IDIs with 60 intervention arm participants at the 6- and 12-month timepoint, a subset of participants who complete the quantitative survey at those time points. The investigators will purposely select individuals assigned to the MEPS intervention arm to ensure diversity and representation according to demographics, time, and study site. Those purposefully sampled for the in-depth interview will be approached by a study research assistant at a routine visit to the partner agency and/or will be send a private message through email or text describing the opportunity to participate in an in-depth interview. Those who are interested will be scheduled for the in-depth interview via a phone or video conference using a secure Zoom platform. In-depth interviews will follow a semi-structured interview guide based on the RE-AIM domains. All interviews will be audio recorded (unless declined by the participant). Guided by REAIM domains of adoption, implementation, and maintenance, they will ask about the MEPS experience, whether it motivated engagement in services, preferred aspects of the intervention, challenges with the intervention, and continued utilization of services or other changes after the intervention ended (interviews at 12 months). Inclusion in this activity will be based upon a purposive sample and the participant's willingness and availability and whether the study has achieved the target sample size for IDIs. The interviews will be audio recorded and transcribed for analysis.

Surveys with Clinic Staff and Leadership Surveys will be completed by CBO staff and leadership employed at the study sites at 12 months after intervention launch (n=60). Using the organizational-level measures from the JCOIN core measures (organizational readiness, organizational climate, staff attitudes, implementation outcomes), study investigators will purposefully select and survey five staff members/agency who were involved with MEPS implementation and assess RE-AIM domains related to adoption, implementation, and maintenance, as well as Proctor's IS outcomes (e.g., acceptability). They will ask leadership to recommend other staff at their agency, at which point the investigator will send them personalized links as well.

In-depth Interviews Staff, Leadership, and Other Stakeholders Community partner staff and leadership employed at the study sites, as well as other county agency stakeholders will be interviewed. Study investigators will conduct IDIs with 21 people at 12 months post intervention start to discuss the setting and environment and the intervention's implementation, acceptability, and practicality for routine use (e.g., enhanced/disrupted operations). The investigators will purposefully select staff from a variety of job titles, demographics, and level of involvement with implementation, as well as Peer Mentors. IDIs will be conducted by trained staff using established procedures, with interview guides designed using the primary domains of the RE-AIM framework. The procedures for administering the interviews to CBO partner staff and outside agency staff will be similar.

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

Scientific data expected from RCT participants:

1. Screener data
2. Extensive quantitative surveys with a few, short open-ended response questions will be administered via phone or video conference at baseline and six- and 12-month follow-ups. The survey data will include sociodemographics; healthcare access; incarceration history; needs; knowledge and attitudes toward HIV, STIs, HCV, and PrEP; social support; sexual and substance use history; use of services related to SUDs, use of PrEP and PEP, symptoms of mental distress, and HIV/STI/HCV screening and diagnoses.
3. Peer session notes

All data elements will be shared, after removal of all personal identifiers, except for notes from the peer sessions. Because of the highly narrative and sensitive nature of the content and the very specific population in the study, these data have a high risk of unintentional identification. The level of redaction needed to remove the potentially identifying/sensitive information would be prohibitive.

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

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.