CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
SPARK +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05323123
NCT05323123N/ACompleted

Preparing for Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries With Low Access to Biomedical Prevention

Columbia University·interventional·Posted Apr 12, 2022·Updated Oct 27, 2025

In Brief

A clinical study evaluating SPARK, HealthMpowerment, and 1 other intervention for Human Immunodeficiency Virus. Completed, enrolled 120 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRomania, United States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 12, 2022
Enrollment StartOct 1, 2021
Primary CompletionSep 30, 2024
Study CompletionNov 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.2 years ago

Interventions

SPARKbehavioral

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

HealthMpowermentbehavioral

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

PrEP Educationbehavioral

Educational information about PrEP provided by physician during medical visits.