CompletedNot Applicable

Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries

United States, Romania120 participantsStarted 2021-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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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

What they're measuring

PrEP Adherence Via Biological Measures (Binary)

Timeframe: Measured at 3 months post-baseline and 6 months post-baseline

Trial details

NCT IDNCT05323123

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

Results submitted2025-09-24