Preparing for pre-exposure prophylaxis implementation in Central-Eastern European Countries with low access to biomedical prevention

Project Summary 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. First, Romania has the 2nd highest increasing HIV incidence of 15 Central-Eastern European (CEE) countries, with gay and bisexual men (GBM) being one of the few epidemic-driving groups; however, there is no national HIV programming for GBM. Second, in a large 2019 GBM report, Romania was the 8th of 44 European countries with the largest gap between PrEP use (1%) and demand (70%). Third, Romania displays some of the highest homophobic attitudes in CEE, keeping GBM in hiding and underutilizing healthcare. Consequently, many Romanian GBM obtain PrEP on their own and use it without medical guidance, thereby increasing their HIV and other health risks. To address the unmet HIV-prevention needs of Romanian GBM, our established US-Romanian team proposes to introduce a culturally-responsive pre-exposure prophylaxis (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. R21-R33 Transition Aim. In mos 21-24, we will summarize PrEP Romania’s promise and anticipated R33 plans. Aim 3 (R33). In mos 1-4, we will make necessary adjustments to PrEP Romania. In mos 5-30, we will randomize 120 PrEP-eligible GBM in two cities to receive either 1) PrEP Romania or 2) a PrEP education condition. We will examine differences across arms in PrEP uptake, adherence, persistence (self-reported and biomarker verified) at 3- and 6-mos post-PrEP initiation. Aim 4 (R33). In mos 31-36, we will identify individual and institutional barriers and facilitators of implementing PrEP Romania by examining Aim 3 feasibility and acceptability data, and via provider, clinic director, and GBM interviews to inform a future hybrid effectiveness-implementation trial.