Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries

Study Overview
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Brief Summary
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To stem increasing rates of HIV among gay and bisexual men in Central-Eastern Europe, the feasibility, acceptability, and early efficacy of a culturally adapted evidence-based program to introduce pre-exposure prophylaxis (PrEP) into Romania's healthcare practice will be established. PrEP Romania, a hybrid in-person + mHealth PrEP uptake and adherence program, aims to empower gay and bisexual men and their healthcare system to adopt PrEP and support adherence. Findings can inform evidence-based PrEP rollout in other Central-Eastern European countries with similar levels of unpreparedness for biomedical prevention.

Detailed Description
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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, an established US-Romanian team proposes to introduce a culturally-responsive pre-exposure prophylaxis (PrEP) program in Romania. Two US-based tools will be integrated and adapted 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. PrEP Romania will be created with the support of a local Partner Consortium of GBM-competent health providers and community members, and be 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, SPARK and P3 will be systematically combined and culturally adapted. Aim 2 (R21). In mos 12-20, 20 GBM will be enrolled 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, PrEP Romania's promise and anticipated R33 plans will be summarized. Aim 3 (R33). In mos 1-4, necessary adjustments will be made to PrEP Romania. In mos 5-30, 120 PrEP-eligible GBM in two cities will be randomized to receive either 1) PrEP Romania or 2) a PrEP education condition. Differences across arms will be examined for PrEP uptake, adherence, persistence (self-reported and biomarker verified) at 3- and 6-mos post-PrEP initiation. Aim 4 (R33). In mos 31-36, individual and institutional barriers and facilitators of implementing PrEP Romania will be identified by examining Aim 3 feasibility and acceptability data, and via provider, clinic director, and GBM interviews to inform a future hybrid effectiveness-implementation trial.

Official Title
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Preparing for Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries With Low Access to Biomedical Prevention

Conditions
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Hiv

Intervention / Treatment
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* Behavioral: PrEP Romania


Participation Criteria
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Eligibility Criteria
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Men will be eligible based on CDC criteria for GBM PrEP candidates, as European guidelines are yet to be formalized: male sex at birth and current male identity; age ≥ 18; ≥1 acts of condomless anal sex with an HIV-positive or status-unknown male partner or diagnosis of bacterial sexually transmitted infection in past 6 months; intentions to start a PrEP regimen; confirmed to be HIV-negative upon study testing; and own a mobile device (smartphone, tablet, laptop); this is highly feasible given the high prevalence of smartphone and internet use in Romania, but we will cover phone plans if needed. Exclusion Criteria: • those not meeting eligibility

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be assigned to a one-arm trial with a baseline and 3-month follow-up.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will receive PrEP | Behavioral: PrEP Romania<br>* Enrolled participants will receive PrEP education and adherence counseling from trained counselors, and have a medical evaluation from a physician, who will prescribe PrEP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants using app (App feasibility) | feasibility defined as at least 50% of individuals used the app on average >2x/week over the 3-month intervention period. | from baseline to 3-month follow-up | 
| Score of app usability rating (App acceptability) | The System Usability Scale (SUS) is a validated 10-item scale that provides a global measure of system usability. The minimum value is 0 and the maximum value is 100, with higher scores indicating better usability. A score > 68 indicates app usability (or acceptability). | from baseline to 3-month follow-up | 
| PrEP Uptake | Yes vs. no (whether or not the participant filled a PrEP prescription). Measure of success is if >90% of participants fill their prescriptions at baseline. | at baseline | 
| PrEP Adherence | Blood plasma concentration indicating ≥4/week dosing indicated by TFVdp ≥700 fmol (using via dried blood spot analysis). | from baseline to 3-month follow-up | 
| PrEP Persistence | Yes vs. no (whether or not the participant stops taking PrEP at any point during follow-up period). Measure of success is if >90% of participants continue to take PrEP at the 3-month follow-up. | from baseline to 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-exposure prophylaxis, gay and bisexual men