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Study Title: Preparing for pre-exposure prophylaxis implementation in Central-Eastern European Countries with low access to biomedical prevention.
Study Implementers: Rutgers University
Study Sponsor(s): Fogarty International Center
Principal Investigator(s): Dr. Corina Lelutiu-Weinberger (Rutgers)
Co-Investigators: Dr. Lisa Hightow-Weidman (UNC), Dr. John Pachankis (Yale)

Description/Purpose: Despite the effectiveness of pre-exposure prophylaxis (PrEP) in preventing HIV acquisition, PrEP is not currently medically prescribed in Romania, although demand is rapidly growing. Evidence-based knowledge is urgently needed to guide PrEP’s effective rollout in Romania. To address the unmet HIV-prevention needs of Romanian GBM, our established US-Romanian team proposes to introduce a culturally-responsive PrEP program in Romania. We will integrate and adapt two tools that we developed and tested in the US 1) SPARK, an in-person motivational intervention for uptake of and adherence to PrEP using an empowering sexual health approach; and 2) P3 (Prepared, Protected, emPowered), a PrEP adherence support app that utilizes engaging social networking and game-based elements, with an in-app portal for individualized live adherence counseling. We will work with our local Partner Consortium of GBM-competent health providers and GBM to create PrEP Romania, composed of both in-person (adapted SPARK to build initial motivation for PrEP uptake and adherence) and mHealth (adapted P3 to provide ongoing app-based PrEP motivation, education, and adherence support) components. Aim 1 (R21). In mos 2-11, using the ADAPT-ITT Model, we will systematically combine and culturally adapt SPARK and P3. Aim 2 (R21). In mos 12-20, we will enroll 20 GBM in a one-arm pilot to test PrEP Romania’s feasibility (e.g., medical visit attendance), acceptability (e.g., intervention staff protocol feedback, GBM interviews about counseling, app usability, and PrEP use), and PrEP uptake (e.g., filled prescriptions), adherence (i.e., self- reported, biomarker verified) and persistence (i.e., still on PrEP) at 3 mos.
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