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临床试验/NCT05424718
NCT05424718已完成不适用

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

Columbia University4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
4
主要终点
Change in Condomless Receptive Sex Acts

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
15 Years 至 25 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in Condomless Receptive Sex Acts

时间窗: 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

次要结局

  • Self-reported Nonoccupational HIV Postexposure Prophylaxis (nPEP) Use(3 and 6 months)
  • Self-reported Pre-exposure Prophylaxis (PrEP) Use(3 and 6 months)
  • Self-reported HIV Testing(3 and 6 months)
  • Self-reported Sexually Transmitted Infections (STI) Testing(3 and 6 months)
  • Change in Partner PrEP Use and Adherence or Viral Suppression(Baseline, 3 and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Schnall, RN, MPH, PhD

Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion

Columbia University

研究点 (4)

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