Recruiting

HIV Prevention

Sponsor:

Columbia University

Code:

NCT06741618

Conditions

HIV/AIDS

Eligibility Criteria

Sex: Male

Age: 16 - 25

Healthy Volunteers: Accepted

Interventions

MyPEEPS Mobile

Electronic PrEP peer navigation

Study Details

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.

Conditions

HIV/AIDS

Study ID

NCT06741618

Start date

Apr 20, 2026

Status verified date

Jun, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 16 - 25

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 16-25 years of age
  • identify as male or non-binary
  • 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
  • currently enrolled in another HIV prevention study

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

MyPEEPS Mobile

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

Electronic PrEP peer navigation

Electronic peer navigation to PreP services

Primary outcome measure

  • PrEP Initiation: [ Time Frame: Baseline, 6-month follow-up, 12-month follow-up ]

Central Contacts and Locations

Central contacts

Rebecca Schnall, PhD, MPH

212-342-6886rb897@columbia.edu

Locations

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Rebecca Schnall

212-342-6886rb897@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • PrEP
  • care navigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-26.