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Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries
Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries

NCT05323123

CompletedNA

Sponsor: Columbia University

Conditions: Human Immunodeficiency Virus

Interventions: SPARK, HealthMpowerment, PrEP Education

Countries: United States, Romania

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.

Eligibility overview

Sex: MALE

Age: 18 Years to

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (3)
  • New York, New York, United States
  • Bucharest, Romania
  • Cluj-Napoca, Romania