Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries
- Conditions
- Human Immunodeficiency Virus
- Interventions
- Drug: Pre-Exposure Prophylaxis (PrEP)Behavioral: PrEP RomaniaBehavioral: SPARKBehavioral: HealthMpowerment
- Registration Number
- NCT05323123
- Lead Sponsor
- Columbia University
- Brief Summary
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
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 months 2-11, using the ADAPT-ITT Model, SPARK and P3 will be systematically combined and culturally adapted.
Aim 2 (R21). In months 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 months. R21-R33 Transition Aim. In mos 21-24, PrEP Romania's promise and anticipated R33 plans will be summarized.
Aim 3 (R33). In months 1-4, necessary adjustments will be made to PrEP Romania. In months 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-months post-PrEP initiation.
Aim 4 (R33). In months 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 120
Not provided
• those not meeting eligibility
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PrEP Romania Pre-Exposure Prophylaxis (PrEP) Participants will receive PrEP, motivational counseling, and adherence support PrEP Romania SPARK Participants will receive PrEP, motivational counseling, and adherence support PrEP Romania HealthMpowerment Participants will receive PrEP, motivational counseling, and adherence support Control Pre-Exposure Prophylaxis (PrEP) Participants will receive PrEP during a medical visit. Control SPARK Participants will receive PrEP during a medical visit. Intervention PrEP Romania Participants will receive PrEP and motivational counseling and adherence support Control PrEP Romania Participants will receive PrEP and counseling
- Primary Outcome Measures
Name Time Method PrEP Adherence via biological measures Baseline and 6 months Blood plasma concentration (using via dried blood spot or DBS analysis); ≥4 doses per week, equivalent to ≥1,000 fmol TFVdp has been shown to be protective against HIV transmission
- Secondary Outcome Measures
Name Time Method Depression Baseline and 6 months Patient Health Questionnaire; minimum value is 0 and maximum value is 27; higher scores indicate increased depression
Percentage of participants using app (App feasibility) Baseline and 6 months feasibility defined as at least 50% of individuals used the app on average \>2x/week over the 3-month intervention period.
Score of app usability rating (App acceptability) Baseline and 6 months 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).
HIV risk Baseline and 6 months number of acts of condomless anal sex with an HIV-positive or status-unknown male partner over the past six months
PrEP adherence via self-report measures Baseline and 6 months PrEP adherence measured via self-report,, both a continuous (average number of PrEP doses taken per week when data were reported, from 0 to 7) and binary variable (0-3 doses per week, on average vs. ≥4 doses per week, on average)
PrEP Persistence Baseline and 6 months Yes vs. no (continuing vs. stopping without restarting PrEP for the 6-month study period, measured dichotomously).
PrEP stigma Baseline and 6 months Reports of anticipated and/or experienced stigma related to PrEP use; higher scores indicate increased stigma
Anxiety Baseline and 6 months Generalized Anxiety Disorder; minimum value is 0 and maximum value is 21; higher scores indicate increased anxiety
Trial Locations
- Locations (2)
Romanian Association Against AIDS
🇷🇴Cluj-Napoca, Romania
Columbia University School of Nursing
🇺🇸New York, New York, United States