NCT06741618

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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 Progress2%
Apr 2026Sep 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
1.3 years until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2028

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

December 15, 2024

Last Update Submit

May 6, 2026

Conditions

HIV/AIDS

Keywords

PrEPcare navigation

Outcome Measures

Primary Outcomes (1)

  • PrEP Initiation:

    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 Outcomes (2)

  • PrEP Adherence

    Baseline, 6-month follow-up, 12-month follow-up

  • PrEP Persistence

    Baseline, 6-month follow-up, 12-month follow-up

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Intervention

EXPERIMENTAL

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 MobileBehavioral: Electronic PrEP peer navigation

Interventions

MyPEEPS MobileBEHAVIORAL

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

ControlIntervention
Electronic PrEP peer navigationBEHAVIORAL

Electronic peer navigation to PreP services

Intervention

Eligibility Criteria

Age16 Years - 25 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale, nonbinary, genderqueer
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

  • Robert Garofalo, MD, MPH

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

  • Lisa Kuhns, PhD, MPH

    Ann & Robert H Lurie Children's Hospital of Chicago

    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
Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion

Study Record Dates

First Submitted

December 15, 2024

First Posted

December 19, 2024

Study Start

April 20, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 16, 2028

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations

US(1)