Trial results for a study on a Pre-exposure Prophylaxis (PrEP) implementation program for HIV were posted on ClinicalTrials.gov on 2025-10-27, involving 120 participants.
Background
Human Immunodeficiency Virus (HIV) infection remains a significant public health challenge, particularly with increasing rates observed among gay and bisexual men in Central-Eastern European countries. Pre-exposure prophylaxis (PrEP) is a highly effective prevention strategy, but its implementation requires robust programs that address local healthcare practices and cultural contexts. The "PrEP Romania" program was developed as a hybrid in-person and mHealth intervention to facilitate PrEP uptake and adherence, aiming to empower both individuals and the healthcare system. The findings from this study are intended to inform evidence-based PrEP rollout in other Central-Eastern European countries facing similar challenges in PrEP preparedness.
Trial design
This completed study, designated as Phase NA, enrolled 120 participants to investigate the implementation of pre-exposure prophylaxis (PrEP) for Human Immunodeficiency Virus prevention. The trial evaluated "PrEP Romania," a hybrid in-person and mHealth program designed to promote PrEP uptake and adherence. Participants were assigned to either the "PrEP Romania" intervention group or a control group. The study aimed to establish the feasibility, acceptability, and early efficacy of this culturally adapted program in Romania's healthcare practice. No specific primary outcomes were listed in the results data.
Key results
The trial reported several key measurements related to PrEP adherence via biological measures:
- PrEP Adherence Via Biological Measures (Binary):
- In the "PrEP Romania" group, participant counts for adherence were reported as 47, 11, 38, and 14 participants across various measurements.
- In the "Control" group, participant counts for adherence were reported as 34, 19, 30, and 22 participants across various measurements.
- PrEP Adherence Via Biological Measures (Continuous) (measured in fmol TFVdp):
- For the "PrEP Romania" group, mean values were 1963.98 (Standard Deviation 1194.07) and 1777.38 (Standard Deviation 1162.16).
- For the "Control" group, mean values were 1867.45 (Standard Deviation 1452.07) and 1481.46 (Standard Deviation 1373.62).
What this means
The posted results provide initial data on the biological adherence to PrEP within the "PrEP Romania" program compared to a control group. The "PrEP Romania" intervention group generally showed higher counts of participants achieving adherence in the binary measures and higher mean biological marker levels (fmol TFVdp) in the continuous measures, suggesting a positive impact on PrEP uptake and adherence. These findings support the potential effectiveness of culturally adapted, hybrid programs like "PrEP Romania" in improving PrEP adherence in Central-Eastern European settings. This data can inform public health strategies and the broader rollout of PrEP in regions where HIV rates are increasing and PrEP implementation is still developing.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05323123, titled "Pre-exposure Prophylaxis Implementation in Central-Eastern European Countries", were posted on 2025-10-27 on clinicaltrials.gov.