NCT05323123Completed
Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries
Preparing for Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries With Low Access to Biomedical Prevention
Source: ClinicalTrials.gov · Last updated 27 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 25 Mar 2022
- Start date
- 1 Oct 2021
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Columbia University
- Diseases
- HIV
- NCT number
- NCT05323123
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 1 Oct 2021 to the primary completion date, 30 Sept 2024
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- those not meeting eligibility
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Romanian Association Against AIDS Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Romanian Association Against AIDS Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Columbia University School of Nursing Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.