N/A
N=120
Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT05323123 ↗Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Oct 2025
Primary outcome: Primary: PrEP Adherence Via Biological Measures (Binary) — 47; 34; 11; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPARK (Behavioral); HealthMpowerment (Behavioral); PrEP Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Columbia University
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PrEP Adherence Via Biological Measures (Binary) |
47; 34; 11; 19; 38; 30 | — |
| SECONDARY PrEP Adherence Via Biological Measures (Continuous) |
1963.98; 1867.45; 1777.38; 1481.46 | — |
| SECONDARY PrEP Adherence Via Self-report Measures (Binary) |
56; 54; 1; 0; 53; 52 | — |
| SECONDARY PrEP Adherence Via Self-report Measures (Continuous) |
6.72; 6.81; 6.62; 6.43 | — |
| SECONDARY PrEP Motivation |
6.52; 6.47; 6.29; 6.07; 6.48; 6.09 | — |
| SECONDARY PrEP Knowledge |
40; 27; 23; 30; 42; 37 | — |
| SECONDARY PrEP Attitudes and Beliefs - Positive Statements Subscore |
14.57; 14.56; 14.60; 14.34; 14.55; 14.49 | — |
| SECONDARY PrEP Attitudes and Beliefs - Negative Statements Subscore |
14.76; 14.19; 14.13; 14.49; 13.95; 14.27 | — |
| SECONDARY PrEP Barriers |
23.05; 25.67; 21.92; 25.21; 22.67; 23.94 | — |
| SECONDARY PrEP Facilitators |
33.14; 35.12; 34.31; 35.27; 34.66; 35.38 | — |
| SECONDARY PrEP Stigma - Score on PrEP Stigma Scale-Shortened Version |
19.68; 20.19; 18.63; 19.91; 18.59; 19.15 | — |
| SECONDARY Depression Symptomology - Score on Patient Health Questionnaire-9 Item (PHQ-9) |
4.35; 5.42; 3.55; 3.29; 4.69; 4.55 | — |
| SECONDARY Anxiety Symptomology - Score on Generalized Anxiety Disorder 7-item(GAD-7) |
3.86; 4.33; 2.69; 2.36; 3.48; 3.34 | — |
| SECONDARY HIV Risk - Number of Condomless Anal Sex (CAS) Acts |
23.60; 21.00; 18.21; 10.04 | — |
| SECONDARY Sexually Transmitted Infection (STI) Diagnoses |
24; 18; 39; 39; 13; 15 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05323123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.