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

NCT ID: NCT06741618

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-12-31

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

Participants randomized to the control arm will receive standard of care information regarding sexual and other behaviors that potentiate one's risk for HIV infection, receipt of a fact sheet about PrEP and PEP, referrals to the local PrEP clinic, and referrals for local sexually transmitted disease testing, and will have access to the MyPEEPS Mobile App during the study.

Group Type: ACTIVE_COMPARATOR

MyPEEPS Mobile

Intervention Type: BEHAVIORAL

An evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence

Intervention

Participants randomized to the intervention arm will have access to the MyPEEPS mobile application and Electronic peer PrEP navigation for the entire 12-month study period.

Group Type: EXPERIMENTAL

MyPEEPS Mobile

Intervention Type: BEHAVIORAL

An evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence

Electronic PrEP peer navigation

Intervention Type: BEHAVIORAL

Electronic peer navigation to PreP services

Interventions

MyPEEPS Mobile

An evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence

Intervention Type: BEHAVIORAL

Electronic PrEP peer navigation

Electronic peer navigation to PreP services

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 16-25 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: collaborator

Callen-Lorde Community Health Center

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Schnall, RN, MPH, PhD

Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Garofalo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Lisa Kuhns, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Columbia University

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rebecca Schnall, PhD, MPH

Role: CONTACT

rb897@columbia.edu

212-342-6886

Facility Contacts

Rebecca Schnall

Role: primary

rb897@cumc.columbia.edu

212-342-6886

Other Identifiers

R01MD019181

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU8894

Identifier Type: -

Identifier Source: org_study_id