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

May 6, 2026 updated by: Rebecca Schnall, RN, MPH, PhD, Columbia University

MyPEEPS Mobile Plus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

500

Phase

  • 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 Locations

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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
  • currently report consistent use of PrEP

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Behavioral: MyPEEPS Mobile
An evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence
Experimental: 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.
Behavioral: MyPEEPS Mobile
An evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence
Behavioral: Electronic PrEP peer navigation
Electronic peer navigation to PreP services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP Initiation:
Time Frame: 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.
Baseline, 6-month follow-up, 12-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP Adherence
Time Frame: Baseline, 6-month follow-up, 12-month follow-up
Daily oral PrEP users will report PrEP use in the past 7-days.
Baseline, 6-month follow-up, 12-month follow-up
PrEP Persistence
Time Frame: 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.
Baseline, 6-month follow-up, 12-month follow-up

Collaborators and Investigators

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

Sponsor

Columbia University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
Ann & Robert H Lurie Children's Hospital of Chicago
Callen-Lorde Community Health Center

Investigators

  • Principal Investigator: Lisa Kuhns, PhD, MPH, Ann & Robert H Lurie Children's Hospital of Chicago
  • Principal Investigator: Robert Garofalo, MD, MPH, Ann & Robert H Lurie Children's Hospital of Chicago

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)

April 20, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 16, 2028

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 15, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU8894
  • R01MD019181 (U.S. NIH Grant/Contract)

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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