NCT06741631

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,200

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Jan 2025Dec 2028

First Submitted

Initial submission to the registry

December 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

December 15, 2024

Last Update Submit

February 24, 2026

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Self-Reported PrEP Initiation

    Baseline, 6 month follow up, 12 month follow up.

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

MyPEEPS MobileBEHAVIORAL

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

Intervention

Eligibility Criteria

Age16 Years - 29 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSex assigned at birth is male and identify gender as male or non-binary
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals who identify as transgender

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Schnall, PhD, MPH

CONTACT

212-342-6886rb897@columbia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Disease Prevention and Health Promotion and Professor of Population and Family Health; Associate Dean of Faculty Development

Study Record Dates

First Submitted

December 15, 2024

First Posted

December 19, 2024

Study Start

January 10, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

US(2)