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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05356910
• Other study ID #: R34MH121234
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: University of California, San Diego
• Contact: Heather A Pines, PhD
• Phone: 619-594-2481
• Email: hpines[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP interest	Self-reported via survey	Baseline
Primary	PrEP linkage	Self-reported via survey and abstracted from medical record	3-month follow-up
Primary	PrEP uptake	Self-reported via survey and abstracted from medical record	3-month follow-up
Secondary	PrEP conversations with peers	Self-reported via survey	Baseline and 3-month follow-up
Secondary	PrEP information	Self-reported via survey	Baseline
Secondary	PrEP motivation	Self-reported via survey	Baseline
Secondary	PrEP behavioral skills	Self-reported via survey	Baseline
Secondary	OPPEN acceptability	Self-reported via survey and exit interview	Baseline and 3-month follow-up
Secondary	OPPEN feasibility	Self-reported via survey and exit interview	Baseline and 3-month follow-up