MyPEEPS Mobile for Young Transgender Men

MyPEEPS (Male Youth Pursuing Empowerment, Education, and Prevention Around Sexuality) Mobile for Young Transgender Men

The proposed MyPEEPS intervention for young transgender men is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information to high risk youth. The final product will be the basis for conducting a large-scale efficacy study in this population.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: MyPEEPS Mobile

Detailed Description

Transgender youth in the United States have unique health needs but often face barriers to accessing and receiving health care services which contribute to disparate health outcomes including high vulnerability to HIV and other sexually transmitted infections. Emerging evidence has begun to document HIV-related sexual risk among young transgender men (YTM), as well as low uptake of pre-exposure prophylaxis among those with indications, suggesting high vulnerability to HIV infection. Despite the high prevalence and increased risk of HIV in YTM who have sex with cisgender men, only one prior HIV prevention intervention has been developed to address the specific sexual health needs of YTM, which indicates a critical gap in HIV prevention science. In response to this need, and building off preliminary work, the investigators propose to develop a mobile intervention for YTM building on MyPEEPS Mobile, which was originally developed for very young sexual minority men. Central to this intervention is the premise that it will be delivered to youth during a developmental period that precedes or coincides with sexual debut, an important time for intervention, prior to or concurrent with initiation of high-risk behaviors.

Given both the gap in HIV prevention science and the lack of current targeted interventions, and building upon our multidisciplinary team's extensive experience in HIV prevention, mobile health (mHealth), behavioral interventions, randomized controlled trials, and transgender health, the investigators propose the following specific aims: 1) Using qualitative methodology, expert feedback, and usability assessments, develop MyPEEPS Mobile for YTM, 2) Conduct a pilot randomized controlled trial to examine the feasibility, acceptability, and preliminary efficacy of the revised MyPEEPS Mobile App in a sample of 80 YTM (15-25 years) and refine the study methods for a future efficacy trial, and 3) Assess predisposing, enabling, and reinforcing factors for MyPEEPS Mobile among YTM through theoretically-guided in depth interviews. The proposed MyPEEPS intervention for YTM will be the first study to develop and pilot a scaled-up, mobile HIV prevention intervention designed by, and piloted for, a diverse group of YTM. The final product of this study will be the basis for an R01 application to conduct a large-scale efficacy study for this population.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Ann & Robert H. Lurie Children's Hospital Chicago
  • New York
    • New York, New York, United States, 10032
      • Columbia University
    • New York, New York, United States, 10011
      • Callen-Lorde Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

To participate in any aspect of the study, participants must be:

• Between 15 and 25 years of age;
• Female sex assigned at birth;
• Identify as a transgender man or along the transmasculine spectrum (including a transmasculine non-binary gender; e.g., male, trans male, transmasculine gender non-binary);
• Understand and read English;
• Live within the US;
• Own a smartphone;
• Self-report condomless receptive anal or vaginal penile sex with either a cisgender male or transgender woman (e.g., individual designated or assigned male at birth) in the past year; and
• Self-report HIV-negative or unknown status.

Exclusion Criteria:

Youth are ineligible to participate in the trial if:

• HIV positive;
• Unable to provide informed consent due to severe mental or physical illness or substance intoxication at the time of enrollment;
• Concurrently enrolled in another HIV prevention study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delayed Intervention; Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile for the first 3 months of the study and will receive access to the MyPEEPS Mobile App at the 3 month follow-up visit.	Behavioral: MyPEEPS Mobile; Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).
Experimental: Immediate Intervention; Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile application for the first three months of the trial and then the intervention is removed at the 3 month follow-up visit.	Behavioral: MyPEEPS Mobile; Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Condomless Receptive Sex Acts	Change in self-reported number of condomless receptive anal or vaginal sex acts with sex partners assigned male at birth	Baseline, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use	Number of participants that self-reported nPEP use	3 and 6 months
Self-reported Pre-exposure Prophylaxis (PrEP) Use	Number of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use	3 and 6 months
Self-reported HIV Testing	Number of participants that self-reported HIV testing	3 and 6 months
Self-reported Sexually Transmitted Infections (STI) Testing	Number of participants that self-reported STI Testing	3 and 6 months
Change in Partner PrEP Use and Adherence or Viral Suppression	Change in participant's self-report of their partner(s) PrEP use and adherence or viral suppression (if partner(s) is HIV+)	Baseline, 3 and 6 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Mental Health (NIMH); Ann & Robert H Lurie Children's Hospital of Chicago; Callen-Lorde Community Health Center
• Investigators: Principal Investigator: Rebecca Schnall, PhD, MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Actual): March 21, 2024
• Study Completion (Actual): March 21, 2024

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Human Immunodeficiency Virus (HIV); Mobile Intervention; MyPEEPS; Transgender Youth
• Other Study ID Numbers: AAAT8624; R34MH128163 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: While individual participant data (IPD) will not be shared, the results of the study will be shared at conferences such as the American Public Health Association annual meeting and Infectious Disease week; provide organizations that are influential in HIV public health practice (e.g., International AIDS Society) with an executive summary, press releases, and/or published papers; publish results in peer-reviewed academic journals; provide a lay summary for participants and community partners.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No