Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT06741631

Conditions

HIV/AIDS

Eligibility Criteria

Sex: Male

Age: 16 - 29

Healthy Volunteers: Accepted

Interventions

MyPEEPS Mobile

Study Details

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.

Conditions

HIV/AIDS

Study ID

NCT06741631

Start date

Jan 10, 2025

Status verified date

Feb, 2026

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 16 - 29

Healthy Volunteers: Accepted

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 Design

Enrollment

3200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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).

Interventions

MyPEEPS Mobile

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

Primary outcome measure

  • HIV Incidence [ Time Frame: Baseline, 6 month follow up, 12 month follow up. ]
  • Total Condomless Anal Sex Occurring in the Context of Insufficient PrEP Protection [ 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

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

Recruiting

Chicago, Illinois, United States, 60611

Columbia University

Recruiting

New York, New York, United States, 10032

More Information

Sponsor

Columbia University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Columbia University on 2026-02-27.