Trial results for a study investigating Pre-Exposure Prophylaxis (PrEP) in the Emergency Department for HIV prevention were posted on ClinicalTrials.gov on 2025-12-09, with 26 participants enrolled.
Background
Despite an increasing armamentarium of behavioral and biomedical HIV prevention methods, rates of new infection have remained around 40,000 annually since 2010. The demonstrated efficacy and subsequent approval of emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis (PrEP) for HIV by the FDA in 2012 was thought to represent a turning point that could significantly reduce the number of new infections. Since approval, the promise of PrEP as a transformative intervention has yet to be fully realized. This study explores methods for PrEP initiation, including in the emergency department setting.
Trial design
This completed study, designated as Phase NA, enrolled 26 participants to investigate conditions including HIV/AIDS and PrEP. The trial compared two approaches to PrEP initiation: 'Out-patient Care for PrEP Initiation' and 'Immediate PreP Initiation'. No specific primary outcomes were listed for this study.
Key results
The trial reported several key measurements related to engagement in care, PrEP usage, sexual behavior, and STI diagnoses across two intervention groups:
- Engagement in Care (Implementation Component):
- For 'Out-patient Care for PrEP Initiation', 1 Participant engaged in care.
- For 'Immediate PreP Initiation', 1 Participant engaged in care.
- Number of Participants on PrEP Usage:
- For 'Out-patient Care for PrEP Initiation', 1 Participant was on PrEP usage.
- For 'Immediate PreP Initiation', 2 Participants were on PrEP usage.
- CDC Sexual Behavior Questions (CSBQ) (RCT Component):
- For 'Out-patient Care for PrEP Initiation', 4 Participants responded to CSBQ.
- For 'Immediate PreP Initiation', 5 Participants responded to CSBQ.
- For 'Out-patient Care for PrEP Initiation', 2 Participants responded to CSBQ.
- For 'Immediate PreP Initiation', 2 Participants responded to CSBQ.
- For 'Out-patient Care for PrEP Initiation', 0 Participants responded to CSBQ.
- For 'Immediate PreP Initiation', 0 Participants responded to CSBQ.
- Number of Participants of New STI Diagnoses (RCT Component):
- For 'Out-patient Care for PrEP Initiation', 1 Participant had new STI diagnoses.
- For 'Immediate PreP Initiation', 2 Participants had new STI diagnoses.
What this means
The posted results provide descriptive data on participant engagement in care and PrEP usage within the context of emergency department-based initiation strategies. With a small enrollment of 26 participants, the study offers preliminary insights into how individuals engaged with PrEP services and reported sexual behaviors and STI diagnoses under two different initiation models. These findings contribute to understanding the operational aspects of PrEP delivery in an emergency department setting, highlighting initial uptake and engagement metrics rather than efficacy outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04429971, titled "Pre-Exposure Prophylaxis in the Emergency Department", were posted on 2025-12-09 on clinicaltrials.gov.