Trial results for the Onboarding Positives and PrEP Users to Engage Negatives (OPPEN) intervention, focused on HIV prevention, were posted on ClinicalTrials.gov on 2025-07-23. The pilot randomized controlled trial enrolled 78 participants.

Background

Human Immunodeficiency Virus (HIV) remains a significant global health challenge, with prevention strategies like pre-exposure prophylaxis (PrEP) being crucial for reducing new infections. Despite its effectiveness, disparities in PrEP uptake and adherence persist, particularly among young men who have sex with men (YMSM) of color. Interventions that leverage social networks and peer-driven education are explored as a method to increase PrEP awareness and engagement within these communities. The OPPEN intervention aimed to train YMSM of color living with HIV or using PrEP to promote PrEP use among HIV-negative YMSM of color in their social networks, addressing a critical need in prevention efforts.

Trial design

This completed pilot randomized controlled trial, designated as Phase NA, enrolled 78 participants to investigate strategies for HIV prevention. The study focused on individuals with HIV, specifically targeting young men who have sex with men (YMSM) of color. The intervention, named Onboarding Positives and PrEP Users to Engage Negatives (OPPEN), involved training YMSM of color living with HIV or using PrEP to promote PrEP use among HIV-negative YMSM of color in their social networks. The trial evaluated OPPEN's acceptability, feasibility, and preliminary effect on PrEP care engagement, comparing outcomes between OPPEN and control groups.

Key results

The trial reported several key measurements related to PrEP engagement and knowledge among participants:

What this means

The results of this pilot trial suggest that the OPPEN peer-driven intervention may be effective in increasing engagement with PrEP among young men who have sex with men (YMSM) of color. Notably, index participants in the OPPEN group reported a higher number of PrEP conversations with peers compared to the control group (15 vs 9 participants). Furthermore, peer-recruit participants in the OPPEN group showed higher mean scores for PrEP information (9.0 vs 5.7) and PrEP motivation (85.5 vs 77.8) compared to the control group. While the counts for PrEP interest, linkage, and uptake were small in both groups, the observed differences in conversations, information, and motivation indicate a potential positive influence of the peer-driven approach on PrEP awareness and intent. These preliminary findings support the feasibility of such interventions and highlight areas for further investigation into their impact on PrEP care engagement.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05356910, titled "Onboarding Positives and PrEP Users to Engage Negatives (OPPEN): Peer-driven Education to Link YMSM of Color to PrEP", were posted on 2025-07-23 on clinicaltrials.gov.