Digital, Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in Young Transgender Women

背景资料。年轻的变性人妇女(YTW)的艾滋病毒流行率/发病率比其他任何人都高 在美国的风险群体。反复暴露于性别少数人的耻辱，加上心理社会 与社会劣势和经济边缘化相关的挑战加剧了艾滋病毒的差距 并使YTW的性别认同失效。这可能导致行为(例如，吸毒、性工作、 避免医疗保健)，这会增加艾滋病毒感染的风险。为了降低青瓦台工人中艾滋病毒的发病率， 干预措施需要1)将艾滋病毒风险作为YTW生活背景的一部分来解决；2)使这些风险变得可及和影响深远 确保整个高危人群(例如农村地区)能够在对他们最方便的时间参与；以及 3)高度可持续，相关成本较低，可在现实环境中实施。初步研究。 目前的建议是对这一人群进行了10多年研究的成果，其中包括：1) 开发和试点以赋权为基础的、团体提供的(亲自)艾滋病毒预防干预措施 针对16-29岁的YTW，称为生活技能计划；2)进行全面、多点随机对照试验 生活技能项目(NIMH R01；MPIS：Garofalo/Mimiaga)的(RCT)，在那里我们展示了这一方法的有效性 减少艾滋病毒风险的干预措施(注：生命技能项目是目前减少艾滋病毒风险的唯一“最佳证据” 对青瓦台的干预包括在疾病预防控制中心的循证干预简编中)；3)适应 Project LifeSkills的面对面版本到在线交付的移动应用程序平台(包含4个在线 模块)通过NIMH资助的R56(MPIs：Kuhns，Mimiaga)，称为“LifeSkills Mobile”；和4)完成 LifeSkills移动应用程序的迭代可用性试点试验，以提高参与者的接受度/研究的可行性 程序，并进行离职访谈，以评估应用程序的外观、手感和功能组件。 概念模型。LifeSkills Mobile是一种促进生物行为艾滋病毒预防的mHealth干预措施 战略基于赋权理论，并使用基于社区的参与性研究来制定 接近。研究设计概述。我们建议进行一项随机对照试验来评估生活技能的效果 在网上招募的5000名YTW中，将移动干预与标准护理(SOC)情况进行比较。 主要结果是艾滋病毒感染事件的减少；次要结果是完全无套肛门/ 阴道性行为发生在PrEP保护不足的情况下。按基准计算，每6个月一次 在为期48个月的时间里，注册参与者将通过手机链接完成一份在线调查 并将邮寄OraQuick家庭艾滋病毒检测试剂盒。我们还将估计以下项目的总成本和增量成本 从医疗保健部门和社会角度来看，LifeSkills移动干预相对于SOC。真实 世界适用性。鉴于面对面、基于群体的广泛传播的固有局限性 干预，LifeSkills Mobile通过开发一款移动设备来扩展干预的潜在范围 版本，并提供有关当前生物行为预防技术(例如PrEP)的内容和访问权限。

Background. Young transgender women (YTW) have the highest HIV prevalence/incidence than any other risk group in the U.S. The repeated exposure to gender minority stigma compounded by the psychosocial challenges associated with social disadvantage and economic marginalization exacerbates disparities in HIV incidence and invalidates YTW’s gender identity. This can lead to behaviors (e.g., substance use, sex work, healthcare avoidance) that potentiate HIV acquisition risk. In order to decrease HIV incidence among YTW, an intervention needs to 1) address HIV risk as part of YTW’s life contexts; 2) be accessible and far-reaching such that the entire at-risk population can participate (e.g., rural areas) during a time most convenient for them; and 3) be highly sustainable with low associated costs to implement in real-world settings. Preliminary Research. The current proposal is a culmination of over 10 years of research with this population, which included: 1) developing and pilot testing an empowerment-based, group-delivered (in person) HIV prevention intervention for YTW ages 16-29, called Project LifeSkills; 2) conducting a full-scale, multisite randomized controlled trial (RCT) of Project LifeSkills (NIMH R01; MPIs: Garofalo/Mimiaga), where we demonstrated the efficacy of this intervention to reduce HIV risk (note: Project LifeSkills is currently the only “best evidence” HIV risk reduction intervention for YTW included among the CDC’s compendium of evidence-based interventions); 3) adapting the face-to-face version of Project LifeSkills to an online-delivered, mobile app platform (containing 4 online modules) via an NIMH-funded R56 (MPIs: Kuhns, Mimiaga), called “LifeSkills Mobile”; and 4) completing an iterative usability pilot trial of the LifeSkills Mobile app to enhance participant acceptability/feasibility of study procedures and conducted exit interviews to evaluate the app’s look, feel, and functional components. Conceptual Model. LifeSkills Mobile is an mHealth intervention to promote biobehavioral HIV prevention strategies based on empowerment theory and was developed using a community-based participatory research approach. Overview of Study Design. We propose to conduct an RCT to assess the efficacy of the LifeSkills Mobile intervention in comparison to a standard of care (SOC) condition among 5,000 YTW recruited online. The primary outcome is reduction in incident HIV infections; a secondary outcome is total condomless anal/ vaginal sex acts occurring in the context of insufficient PrEP protection. At baseline and every 6 months through 48 months, enrolled participants will complete an online survey sent via a link to their mobile phone and will be mailed an OraQuick In-Home HIV Test kit . We will also estimate the total and incremental costs of the LifeSkills Mobile intervention relative to SOC, from healthcare sector and societal perspectives. Real World Applicability. Given inherent limitations to widespread dissemination of face-to-face, group-based interventions, LifeSkills Mobile extends the potential reach of the intervention via the development of a mobile version, and provides content on, and access to, current biobehavioral prevention technologies (e.g., PrEP).