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

NCT05356910 | Completed Results

• 1 other identifier: R34MH121234
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

• PrEP Interest (Peer-Recruit Participants)

  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.

  Baseline

• PrEP Linkage (Peer-Recruit Participants)

  Attended a PrEP care visit since baseline.

  3-month follow-up

• PrEP Uptake (Peer-Recruit Participants)

  Started using oral or injectable PrEP since baseline.

  3-month follow-up

Secondary Outcomes (8)

• PrEP Conversations With Peers (Index Participants)

  3-month follow-up

• PrEP Information (Peer-Recruit Participants)

  Baseline

• PrEP Motivation (Peer-Recruit Participants)

  Baseline

• PrEP Behavioral Skills (Peer-Recruit Participants)

  Baseline

• Session Acceptability (Index Participants)

  3-month follow-up

Study Arms (2)

OPPEN Intervention

EXPERIMENTAL

OPPEN consists of three small-group and two one-on-one sessions to train YMSM of color engaged in HIV or PrEP care to be peer PrEP educators within their social networks.

Behavioral: OPPEN

Control Condition

OTHER

The time- and attention-matched control condition consists of three small-group and two one-on-one sessions to support diet and nutrition behavior change.

Behavioral: Control Condition

Interventions

OPPEN BEHAVIORAL

OPPEN training sessions (three small-group and two one-on-one sessions) build skills for effective peer PrEP outreach through didactic instruction, group discussions, role-play exercises, and goal planning and problem-solving activities.

OPPEN Intervention

Control Condition BEHAVIORAL

Control sessions (three small-group and two one-on-one sessions) build skills for diet and nutrition behavior change through didactic instruction, group discussions, and goal planning and problem-solving activities.

Control Condition

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: Persons screened for eligibility will be asked their gender identity. Those who identify as cisgender men will be eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years-old
• Cisgender male
• Fluent in English or Spanish
• Person of color
• HIV-negative
• Not using PrEP

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

Results Point of Contact

• Title: Heather Pines
• Organization: University of California, San Diego

hpines@health.ucsd.edu

619-594-2481

Study Officials

• Heather A Pines, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: April 7, 2022
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: July 23, 2025
• Results First Posted: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Approximately 6 months after the publication of the study's primary findings.
• Access Criteria: Requests from researchers for de-identified data will be reviewed by the research team (Principal Investigator and Co-Investigators).

Locations

US (1)