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NCT05356910

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

Completed NA Results posted Last updated 23 July 2025
What this trial tests

NA trial testing OPPEN in HIV in 78 participants. Completed in 31 August 2024.

Timeline
7 April 2022
Primary endpoint
31 July 2024
31 August 2024

Quick facts

Lead sponsorUniversity of California, San Diego
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment78
Start date7 April 2022
Primary completion31 July 2024
Estimated completion31 August 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Diego

Who can join

Adults 18 to 34, male only, with HIV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PrEP Interest (Peer-Recruit Participants) Primary · Baseline

Participants used 5-point Likert scale responses (very uninterested to very interested) to indicate their interest in taking oral PrEP ("How interested are you in taking oral PrEP to prevent HIV?") and injectable PrEP ("How interested are you in taking injectable PrEP to prevent HIV?"). Responses of "interested" or "very interested" in either oral or injectable PrEP defined PrEP interest.

GroupValue95% CI
OPPEN Peer-Recruit Participants2
Control Peer-Recruit Participants3
PrEP Linkage (Peer-Recruit Participants) Primary · 3-month follow-up

Attended a PrEP care visit since baseline.

GroupValue95% CI
OPPEN Peer-Recruit Participants1
Control Peer-Recruit Participants2
PrEP Uptake (Peer-Recruit Participants) Primary · 3-month follow-up

Started using oral or injectable PrEP since baseline.

GroupValue95% CI
OPPEN Peer-Recruit Participants1
Control Peer-Recruit Participants2
PrEP Conversations With Peers (Index Participants) Secondary · 3-month follow-up

Reported having conversations about PrEP with at least one YMSM peer in their social network in the last three months.

GroupValue95% CI
OPPEN Index Participants15
Control Index Participants9
PrEP Information (Peer-Recruit Participants) Secondary · Baseline

Sum score on 13-item PrEP knowledge scale where higher scores indicate greater PrEP knowledge (range: 0-13).

GroupValue95% CI
OPPEN Peer-Recruit Participants9.0± 2.8
Control Peer-Recruit Participants5.7± 2.9
PrEP Motivation (Peer-Recruit Participants) Secondary · Baseline

Sum of 5-point Likert scale responses (strongly disagree to strongly agree) to scales measuring PrEP attitudes (5 items), PrEP stigma (5 items), subjective PrEP norms (6 items), and descriptive PrEP norms (6 items) where higher scores indicate greater motivation to use PrEP (range: 22-110).

GroupValue95% CI
OPPEN Peer-Recruit Participants85.5± 9.2
Control Peer-Recruit Participants77.8± 13.9
PrEP Behavioral Skills (Peer-Recruit Participants) Secondary · Baseline

Sum score on 8-item PrEP self-efficacy scale where higher scores indicate greater PrEP self-efficacy (range: 8-32).

GroupValue95% CI
OPPEN Peer-Recruit Participants30.5± 0.7
Control Peer-Recruit Participants23.5± 5.8
Session Acceptability (Index Participants) Secondary · 3-month follow-up

Mean score of 5-point Likert scale responses (strongly disagree to strongly agree) to 21 items measuring acceptability of OPPEN/control sessions among index participants where higher scores indicate greater acceptability (range: 1-5).

GroupValue95% CI
OPPEN Index Participants4.5± 0.4
Control Index Participants4.3± 0.4
Session Feasibility (Index Participants) Secondary · 3-month follow-up

Mean score of 5-point Likert scale responses (strongly disagree to strongly agree) to 5 items measuring feasibility of OPPEN/control sessions among index participants where higher scores indicate greater feasibility (range: 1-5).

GroupValue95% CI
OPPEN Index Participants4.2± 0.7
Control Index Participants3.9± 0.5
Acceptability of Interaction With Referring Index (Peer-Recruit Participants) Secondary · Baseline

Mean score of 5-point Likert scale responses (strongly disagree to strongly agree) to 9 items measuring the acceptability of the interaction with their peer (OPPEN or control index) when they referred them to the study among peer-recruit participants where higher scores indicate greater acceptability (range: 1-5).

GroupValue95% CI
OPPEN Peer-Recruit Participants4.7± 0.4
Control Peer-Recruit Participants3.6± 0.8
Feasibility of Interaction With Referring Index (Peer-Recruit Participants) Secondary · Baseline

Mean score of 5-point Likert scale responses (strongly disagree to strongly agree) to 2 items measuring the feasibility of the interaction with their peer (OPPEN or control index) when they referred them to the study among peer-recruit participants where higher scores indicate greater feasibility (range: 1-5).

GroupValue95% CI
OPPEN Peer-Recruit Participants4.5± 0.7
Control Peer-Recruit Participants4.0± 0.6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for HIV

Currently open trials in the same condition.

Other University of California, San Diego trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05356910.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing