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Completed

NCT Number: NCT05424718

MyPEEPS 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.

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Key information

Age range

15 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H. Lurie Children's Hospital Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MyPEEPS Mobile

Behavioral

Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).

Primary outcomes

  1. Change in Condomless Receptive Sex Acts

    Time frame: Baseline, 3 and 6 months

    Change in self-reported number of condomless receptive anal or vaginal sex acts with sex partners assigned male at birth

Secondary outcomes

  1. Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use

    Time frame: 3 and 6 months

    Number of participants that self-reported nPEP use

  2. Self-reported Pre-exposure Prophylaxis (PrEP) Use

    Time frame: 3 and 6 months

    Number of participants that self-reported Pre-exposure Prophylaxis (PrEP) Use

  3. Self-reported HIV Testing

    Time frame: 3 and 6 months

    Number of participants that self-reported HIV testing

  4. Self-reported Sexually Transmitted Infections (STI) Testing

    Time frame: 3 and 6 months

    Number of participants that self-reported STI Testing

  5. Change in Partner PrEP Use and Adherence or Viral Suppression

    Time frame: Baseline, 3 and 6 months

    Change in participant's self-report of their partner(s) PrEP use and adherence or viral suppression (if partner(s) is HIV+)

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Callen-Lorde Community Health Center
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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