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

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: Recruiting
• Conditions: HIV
• Intervention / Treatment: Behavioral: OPPEN; Behavioral: Control Condition

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; 50% HIV-positive) 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: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather A Pines, PhD; Phone Number: 619-594-2481; Email: hpines@health.ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • Recruiting
      • University of California, San Diego
      • Contact: Heather A Pines, PhD; Phone Number: 619-594-2481; Email: hpines@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
PrEP interest	Self-reported via survey	Baseline
PrEP linkage	Self-reported via survey and abstracted from medical record	3-month follow-up
PrEP uptake	Self-reported via survey and abstracted from medical record	3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP conversations with peers	Self-reported via survey	Baseline and 3-month follow-up
PrEP information	Self-reported via survey	Baseline
PrEP motivation	Self-reported via survey	Baseline
PrEP behavioral skills	Self-reported via survey	Baseline
OPPEN acceptability	Self-reported via survey and exit interview	Baseline and 3-month follow-up
OPPEN feasibility	Self-reported via survey and exit interview	Baseline and 3-month follow-up

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Heather A Pines, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID 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