Men who have sex with men (MSM), especially young Black/African American (“Black”) and Hispanic/Latino (“Latino”) MSM, have the highest rates of HIV diagnoses in the United States (US), illustrating the need for timely, efficacious, and culturally congruent HIV prevention tools for these populations. One such tool is pre-exposure prophylaxis (PrEP), which is one of the pillars to prevent new HIV infections in the Ending the HIV Epidemic: A Plan for America initiative in the US. Increasing PrEP use by priority populations is an urgent HIV prevention need. There are three PrEP options currently or soon to be available: 1) daily oral PrEP comprised of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) or tenofovir alafenamide and emtricitabine (TAF/FTC), 2) 2-1- 1 dosing of TDF/FTC, and 3) bi-monthly injectable long-acting cabotegravir (CAB-LA), which is expected to become available in as soon as a few months. Yet, uptake of PrEP is inverse to HIV acquisition risk among Black and Latino young MSM who are less likely to access and adhere to PrEP than White and older MSM despite being the highest risk group for acquiring HIV relative to other racial/ethnic and age groups. There are both provider-level barriers to increasing PrEP screening, counseling, and initiation among priority populations and patient-level barriers to adherence and persistence to PrEP. Therefore, our proposed study will target: 1) provider-level barriers to optimal PrEP screening, counseling, and initiation through practice facilitation and a provider training on culturally congruent PrEP options, and 2) patient-level barriers to PrEP adherence and persistence through a mobile health (mHealth) tool (mChoice App). Building on the only CDC evidence-based intervention for PrEP medication adherence/persistence, PrEPmate, and our own formative work with the CDC (U01PS003715; PI: Schnall) to design and build a mHealth app and integrate it with a smart pill box (CleverCap), the patient-level intervention, mChoice App, will enable oral PrEP users to self-monitor their medication adherence in real-time; provide key information about PrEP choices, reminder messages about appointments, videos, and testimonials of peers taking PrEP; and promote two-way communication between participants and the study staff during the study. The practice facilitation intervention will comprise three phases: pre- implementation planning, which will include provider training around culturally congruent PrEP options, implementation with formative evaluation, and post-implementation summative evaluation. To assess the effectiveness, we will conduct a Hybrid Type II trial simultaneously testing the effectiveness of a culturally congruent clinical intervention (mChoice App) and an implementation intervention (practice facilitation) guided by complementary implementation and evaluation frameworks–the Consolidated Framework for Implementation Research (CFIR) and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). Findings will have the potential to improve PrEP delivery for young Black and Latino MSM and, ultimately, decrease the incidence of new HIV infections in two high-priority settings in the US, New York City and Birmingham, Alabama.

PROJECT NARRATIVE Men who have sex with men (MSM), especially young Black and Latino MSM, have the highest rates of HIV diagnoses in the United States. The goal of the proposed Type II Hybrid Study is to improve pre-exposure prophylaxis screening, counseling, initiation, adherence, and persistence in young Black and Latino MSM in two high-priority settings.