MyPEEPS LITE Trial

This study will use community-informed advertisements and messages through electronic methods to recruit and retain a large (N=3,200), diverse national sample of high-risk young men who have sex with men (YMSM) and non-binary individuals that are assigned male sex at birth, 16-29 years of age to determine the efficacy of the MyPEEPS Mobile intervention on reduced incident HIV infections in comparison to a standard of care condition and to examine the degree to which reduced incident HIV infections occurs in the context of potential multilevel moderators and conceptual mediators. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: MyPEEPS Mobile

Detailed Description

In direct response to RFA-AI-21-018, Limited Interaction Targeted Epidemiology (LITE-2): To Advance HIV Prevention (UG3/UH3 Clinical Trial Optional), we proposed to harness innovative electronic methods to conduct a large, rigorous national study collecting and contextualizing epidemiological HIV incidence data in Young Men who have Sex with Men (YMSM) and testing the efficacy of MyPEEPS Mobile, an evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence. We proposed to establish a large national cohort of 3,200 racially and ethnically diverse YMSM 16-29 years old, the age YMSM are most susceptible to HIV acquisition to identify theoretically-driven correlates of HIV seroconversion among a key population experiencing a disproportionate number of new HIV diagnoses.

Randomized controlled trials (RCTs) are considered the gold standard for estimating treatment efficacy because randomization mitigates risk of bias by balancing measured and unmeasured confounders across treatment groups. However, RCTs are costly, time-consuming, and can be challenging to conduct in certain context. We are therefore integrating the robust epidemiological data that we collected during the UG3 phase into the clinical trial design. That integration is a potentially appealing way to generate an external comparator cohort to increase the power of our RCT to estimate the effect of MyPEEPS Mobile on HIV incidence.

• Study Type: Interventional
• Enrollment (Estimated): 3200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Schnall, PhD, MPH; Phone Number: 212-342-6886; Email: rb897@columbia.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H. Lurie Children's Hospital of Chicago
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Be between 16-29 years of age;
• Sex assigned at birth is male and identify gender as male or non-binary;
• Understand and read English;
• Live within US and its territories;
• Own or have access to a smartphone;
• Self-report anal sex with someone who has a penis in the last 12 months; and
• Be HIV-negative or status unknown

Exclusion Criteria:

• Individuals who identify as transgender

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants randomized to the control arm will receive standard of care. This consists of HIV home testing every 6 months, 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.
Experimental: Intervention; Participants randomized to the intervention arm will have access to MyPEEPS Mobile for the next 6 months. MyPEEPS Mobile is a secure web app with content delivered through games, scenarios, and role-plays within 22 mobile activities (true/ false questions, multiple choice, matching, videos).	Behavioral: MyPEEPS Mobile; An evidence-based, digitally delivered mHealth sexual risk reduction intervention on HIV incidence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Incidence	OraQuick In-Home HIV Tests will be shipped to participants at baseline, 6 and 12 months.	Baseline, 6 month follow up, 12 month follow up.
Total Condomless Anal Sex Occurring in the Context of Insufficient PrEP Protection	Condomless anal sex acts not protected by PrEP, defined as condomless anal sex acts in the prior 6 months without protection via PrEP. We will measure sexual risk with the AIDS-Risk Behavior Assessment.	Baseline, 6 month follow up, 12 month follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported PrEP Initiation	Self reported PrEP initiation variables will be measured for the purposes of characterizing the uptake of PrEP over the course of the study. We will use a self-reported approach to capture the date of initiation of medication, current use, and most recent date the medication was taken.	Baseline, 6 month follow up, 12 month follow up.

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Northwestern University; Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Rebecca Schnall, PhD, MPH, Columbia University; Principal Investigator: Robert Garofalo, MD, MPH, Ann & Robert H Lurie Children's Hospital of Chicago; Principal Investigator: Dustin Duncan, ScD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 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): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: AAAV4619; UH3AI169658 (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.: Yes