MyPEEPS Mobile for Young Transgender Men

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05424718
• Other study ID #: AAAT8624
• Secondary ID: R34MH128163
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 16, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital Chicago	Chicago	Illinois
United States	Callen-Lorde Community Health Center	New York	New York
United States	Columbia University	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Columbia University	Ann & Robert H Lurie Children's Hospital of Chicago, Callen-Lorde Community Health Center, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in self-reported Nonoccupational HIV postexposure prophylaxis (nPEP) and pre-exposure prophylaxis (PrEP) use	Change in self-reported nPEP and PrEP	Baseline, 3 and 6 months
Secondary	Change in self-reported HIV and sexually transmitted infections (STI) testing	Change in self-reported HIV and STI testing	Baseline, 3 and 6 months
Secondary	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