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Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries

NCT05323123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-10-27

Study results available
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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.

Conditions

  • Human Immunodeficiency Virus

Interventions

BEHAVIORAL

SPARK

SPARK is delivered in a clinic setting by a counselor using motivational interviewing techniques (e.g., open-ended questions, affirmations).

BEHAVIORAL

HealthMpowerment

PrEP adherence support app that utilizes engaging social networking and game-based elements, with an in-app portal for individualized live adherence counseling.

BEHAVIORAL

PrEP Education

Educational information about PrEP provided by physician during medical visits.

Sponsors & Collaborators

  • Yale University

    collaborator OTHER

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Corina Lelutiu-Weinberger, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-09-30
Completion
2024-11-30

Countries

  • United States
  • Romania

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323123 on ClinicalTrials.gov