MyPEEPS Mobile for Young Transgender Men

NCT ID: NCT05424718

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-16
• Study Completion Date: 2024-03-21

Brief 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.

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

MyPEEPS Mobile

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

MyPEEPS Mobile

Intervention Type: BEHAVIORAL

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

Interventions

MyPEEPS Mobile

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: collaborator

Callen-Lorde Community Health Center

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Schnall, RN, MPH, PhD

Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Schnall, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R34MH128163

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT8624

Identifier Type: -

Identifier Source: org_study_id