Status:
COMPLETED
Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Yale University
Fogarty International Center of the National Institute of Health
Conditions:
Human Immunodeficiency Virus
Eligibility:
MALE
18+ years
Phase:
NA
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...
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 kn...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05323123
Start Date
October 1 2021
End Date
November 30 2024
Last Update
October 27 2025
Active Locations (3)
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1
Columbia University School of Nursing
New York, New York, United States, 10032
2
Romanian Association Against AIDS
Bucharest, Romania
3
Romanian Association Against AIDS
Cluj-Napoca, Romania