MyPEEPS Mobile Plus: A Multi-Level HIV Prevention Intervention for Young MSM

Not Applicable

Recruiting

• Conditions: HIV/AIDS

• Registration Number: NCT06741618
• Lead Sponsor: Columbia University

Brief Summary

MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.

Detailed Description

This study expands MyPEEPS Mobile to develop MyPEEPS Mobile Plus, a multi-level intervention comprised of MyPEEPS Mobile with added PrEP content (based upon expert advisory and youth feedback) + PrEP E-Peer Navigation to overcome the challenges of PrEP initiation, adherence, and persistence among YMSM. Peer navigation is an evidence-based, widely recommended intervention for reaching youth and MSM for HIV-related care outcomes, with evidence of acceptability among racial/ethnic minority YMSM for PrEP. Peer navigation addresses common reasons for failing to begin or maintain PrEP use, including low perceived risk, structural or logistic barriers to care engagement, and anticipated side effects. Relative to in-person and group-based HIV prevention programs, behavioral interventions with digital and virtual components can have vast reach and present unique potential to rapidly scale delivery to very large and hidden groups. Therefore, the investigators propose to conduct a randomized controlled trial to test the efficacy of MyPEEPS Mobile Plus (a multi-level intervention comprised of MyPEEPS Mobile + PrEP E-Peer Navigation) for promoting initiation, adherence, and persistence of PrEP and decreased HIV risk behavior in YMSM. Building upon the team's demonstrated ability to enroll large numbers of young racially and ethnically diverse YMSM and extensive experience developing mobile health interventions, the proposed study will test the efficacy of this expanded, multi-level mobile HIV prevention intervention emphasizing PrEP. If efficacious, it will increase PrEP initiation, adherence, and persistence and decrease overall HIV risk in diverse YMSM in the US.

Study Timeline

• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-15
• Study First Posted: 2024-12-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Study Start: 2025-03-31
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

• 17-25 years of age
• identify as male, non-binary, or genderqueer
• male sex assigned at birth
• understand and read english
• own a smartphone
• report condomless anal sex with a male in the past year
• HIV-negative (OraQuick verified)

Exclusion Criteria

• HIV Positive
• If study staff determine participant unable to consent due to obvious and severe cognitive impairment or under the influence of drugs or alcohol
• Transgender identity
• currently report consistent use of PrEP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PrEP Initiation:	Baseline, 6-month follow-up, 12-month follow-up	Participants will self-report attending at least one PrEP-related care visit to asess medical eligibility for PrEP initiation.

Secondary Outcome Measures

Name	Time	Method
PrEP Adherence	Baseline, 6-month follow-up, 12-month follow-up	Daily oral PrEP users will report PrEP use in the past 7-days.
PrEP Persistence	Baseline, 6-month follow-up, 12-month follow-up	Questions will be measure visit constancy, i.e., self-report at least 1 PrEP related care visit in the past 6 months.

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States