N/A
Completed N=120
Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries
Source: ClinicalTrials.gov NCT05323123 ↗Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Oct 2025
Primary outcomePrimary: PrEP Adherence Via Biological Measures (Binary) — 47; 34; 11; 19 Participants
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.
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 | — |
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. Informational only — not medical advice.