Clinical trial NCT05424718: MyPEEPS Mobile for Young Transgender Men
Official title: MyPEEPS (Male Youth Pursuing Empowerment, Education, and Prevention Around Sexuality) Mobile for Young Transgender Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: MyPEEPS
Mobile Intervention
Human Immunodeficiency Virus (HIV)
Transgender Youth
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Callen-Lorde Community Health Center
First posted: 2022-06-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Condomless Receptive Sex Acts
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use
timeFrame: 3 and 6 months
measure: Self-reported Pre-exposure Prophylaxis (PrEP) Use
timeFrame: 3 and 6 months
measure: Self-reported HIV Testing
timeFrame: 3 and 6 months
measure: Self-reported Sexually Transmitted Infections (STI) Testing
timeFrame: 3 and 6 months
measure: Change in Partner PrEP Use and Adherence or Viral Suppression
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital Chicago
state: Illinois
city: New York
country: United States
facility: Callen-Lorde Community Health Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Rebecca Schnall, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: