MyPEEPS Mobile for Young Transgender Men

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: MyPEEPS Mobile


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The intervention arm receives the intervention from baseline to 3 months and at the 3 month visit, access to the intervention is removed and the control/ delayed intervention arm then receives the intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention<br>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<br>* Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).<br>|
| Experimental: Delayed Intervention<br>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<br>* Mobile technology to deliver HIV prevention information specifically developed for at-risk young men that have sex with men (YMSM).<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Change in self-reported HIV and sexually transmitted infections (STI) testing | Change in self-reported HIV and STI testing | Baseline, 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MyPEEPS, Mobile Intervention, Human Immunodeficiency Virus (HIV), Transgender Youth