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

July 2, 2025 updated by: Heather Pines, University of California, San Diego
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pre-exposure prophylaxis (PrEP) uptake has been slow among young men who have sex with men (YMSM), particularly those of color who experience a high rate of new HIV infections in the United States. Limited PrEP knowledge, unfamiliarity with how to access PrEP, medical mistrust, and stigma are barriers to PrEP care engagement among YMSM, including those of color. Peer-driven social network interventions that train individuals as peer educators to disseminate information about HIV prevention and treatment within their social networks have been implemented to address similar barriers and improve HIV outcomes within hard to reach populations. YMSM of color engaged in HIV/PrEP care often employ resilience processes to overcome socio-structural barriers to HIV prevention and care. As such, training YMSM of color engaged in HIV/PrEP care as peer PrEP educators may position them as credible sources of PrEP information who can influence behavior change (i.e., PrEP care engagement) among YMSM peers of color in their social networks via their ability to disseminate culturally competent PrEP messages in the context of their personal experiences using these resilience processes to navigate the healthcare system, medical mistrust, and stigma. Drawing on existing peer-driven social network interventions, the diffusion of innovations and information-motivation-behavioral skills models, and Harper et al.'s resilience framework, this study will develop and pilot Onboarding Positives and PrEP users to Engage Negatives (OPPEN), a peer-driven PrEP education social network intervention, among YMSM of color in San Diego, California. Through three small-group and two one-on-one sessions, OPPEN will train YMSM of color engaged in HIV/PrEP care to be peer PrEP educators within their social networks. In Phase I, OPPEN was developed, pretested, and refined using an iterative process that integrated feedback elicited from YMSM of color living with HIV and YMSM using PrEP trained via OPPEN as well as HIV-negative YMSM who could benefit from PrEP (AIM 1). In Phase II, OPPEN will be piloted in a randomized controlled trial with 70 YMSM of color engaged in HIV/PrEP care (i.e., indexes; up to two-thirds engaged in PrEP care) randomly assigned to OPPEN (n=35) or a time- and attention-matched control condition (n=35). All indexes will receive coupons to recruit YMSM peers of color within their social networks to the study. Assuming ~2 peers will be recruited per index, ~140 peers will present at the study site (i.e., peer-recruits) and undergo HIV testing. HIV-negative peer-recruits interested in PrEP will be scheduled for a PrEP clinic visit. Data collected via surveys (baseline and 3-month study visits) and medical records will be used to evaluate the preliminary effect of OPPEN on PrEP interest, linkage, and uptake among peer-recruits (AIM 2) and theory-based mechanisms targeted by OPPEN among indexes and peer-recruits (AIM 3). OPPEN acceptability and feasibility will be evaluated using a mixed-methods approach (AIM 4).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OPPEN Intervention
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
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.
Other: Control Condition
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PrEP Interest (Peer-Recruit Participants)
Time Frame: 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.
Baseline
PrEP Linkage (Peer-Recruit Participants)
Time Frame: 3-month follow-up
Attended a PrEP care visit since baseline.
3-month follow-up
PrEP Uptake (Peer-Recruit Participants)
Time Frame: 3-month follow-up
Started using oral or injectable PrEP since baseline.
3-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PrEP Conversations With Peers (Index Participants)
Time Frame: 3-month follow-up
Reported having conversations about PrEP with at least one YMSM peer in their social network in the last three months.
3-month follow-up
PrEP Information (Peer-Recruit Participants)
Time Frame: Baseline
Sum score on 13-item PrEP knowledge scale where higher scores indicate greater PrEP knowledge (range: 0-13).
Baseline
PrEP Motivation (Peer-Recruit Participants)
Time Frame: 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).
Baseline
PrEP Behavioral Skills (Peer-Recruit Participants)
Time Frame: Baseline
Sum score on 8-item PrEP self-efficacy scale where higher scores indicate greater PrEP self-efficacy (range: 8-32).
Baseline
Session Acceptability (Index Participants)
Time Frame: 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).
3-month follow-up
Session Feasibility (Index Participants)
Time Frame: 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).
3-month follow-up
Acceptability of Interaction With Referring Index (Peer-Recruit Participants)
Time Frame: 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).
Baseline
Feasibility of Interaction With Referring Index (Peer-Recruit Participants)
Time Frame: 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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather A Pines, PhD, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34MH121234 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available upon review of written requests from researchers.

IPD Sharing Time Frame

Approximately 6 months after the publication of the study's primary findings.

IPD Sharing Access Criteria

Requests from researchers for de-identified data will be reviewed by the research team (Principal Investigator and Co-Investigators).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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