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N/A Completed N=78 Randomized Double-blind Prevention

Onboarding Positives and PrEP Users to Engage Negatives (OPPEN): Peer-driven Education to Link YMSM of Color to PrEP

Source: ClinicalTrials.gov NCT05356910 ↗
Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: PrEP Interest (Peer-Recruit Participants) — 2; 3 Participants

Summary

Onboarding Positives and PrEP users to Engage Negatives (OPPEN) is an intervention to train young men who have sex with men (YMSM) of color living with HIV or using pre-exposure prophylaxis (PrEP) to promote PrEP use among HIV-negative YMSM of color in their social networks. This pilot randomized controlled trial will evaluate OPPEN's acceptability, feasibility, and preliminary effect on PrEP care engagement among YMSM of color.

Outcome Measures

OutcomeResultp-value
PRIMARY
PrEP Interest (Peer-Recruit Participants)
2; 3
PRIMARY
PrEP Linkage (Peer-Recruit Participants)
1; 2
PRIMARY
PrEP Uptake (Peer-Recruit Participants)
1; 2
SECONDARY
PrEP Conversations With Peers (Index Participants)
15; 9
SECONDARY
PrEP Information (Peer-Recruit Participants)
9.0; 5.7
SECONDARY
PrEP Motivation (Peer-Recruit Participants)
85.5; 77.8
SECONDARY
PrEP Behavioral Skills (Peer-Recruit Participants)
30.5; 23.5
SECONDARY
Session Acceptability (Index Participants)
4.5; 4.3
SECONDARY
Session Feasibility (Index Participants)
4.2; 3.9
SECONDARY
Acceptability of Interaction With Referring Index (Peer-Recruit Participants)
4.7; 3.6
SECONDARY
Feasibility of Interaction With Referring Index (Peer-Recruit Participants)
4.5; 4.0

Eligibility Criteria

Inclusion Criteria (Index Participants):

  • 18-34 years-old
  • Cisgender male
  • Fluent in English
  • Person of color
  • Engaged in HIV care or PrEP care
  • Sexual activity with cisgender men or transgender women in their lifetime
  • Social networks with at least three 18-34 year-old MSM peers of color
  • Willing to disclose their HIV status or PrEP use to their 18-34 year-old MSM peers of color
  • Willing to provide written informed consent

Inclusion Criteria (Peer-Recruit Participants):

  • 18-34 years-old
  • Cisgender male
  • Fluent in English or Spanish
  • Person of color
  • HIV-negative
  • Not using PrEP
  • Sexual activity with cisgender men or transgender women in their lifetime
  • Willing to provide written informed consent

Exclusion Criteria

  • Persons who meet the criteria above will be eligible, no other exclusion criteria will apply.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05356910). 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.

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