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

背景年轻的变性妇女（YTW）的艾滋病毒感染率/发病率比任何其他人都高 反复暴露于性别少数的耻辱，加上心理社会因素， 与社会不利地位和经济边缘化相关的挑战加剧了艾滋病毒方面的差距 事件和失效YTW的性别认同。这可能会导致行为（例如，吸毒，性工作， 避免医疗保健），这会增加HIV感染风险。为了降低艾滋病病毒感染率， 干预需要1）将艾滋病毒风险作为YTW生活环境的一部分; 2）可获得和深远的， 整个高危人群都可以参与（例如，在对他们最方便的时间内， 3)具有高度可持续性，在现实环境中实施的相关成本低。初步研究。 目前的提案是对这一人群进行了10多年研究的结果，其中包括： 制定和试点测试一种基于赋权的、群体提供的（亲自）艾滋病毒预防干预措施 对于16-29岁的YTW，称为生活技能项目; 2）进行全面的多地点随机对照试验 (RCT)生活技能项目（NIMH R 01; MPI：Garofalo/Mimiaga），我们在那里证明了这种方法的有效性。 降低艾滋病毒风险的干预措施（注：生活技能项目是目前降低艾滋病毒风险的唯一“最佳证据” （三）将青少年工作坊的干预措施纳入疾病预防控制中心的循证干预措施汇编）;（三）适应 面对面版本的生活技能项目，以在线交付，移动的应用程序平台（包含4个在线 模块）通过NIMH资助的R56（MPI：Kuhns，Mimiaga），称为“生活技能移动的”;以及4）完成 LifeSkills移动的应用程序的迭代可用性试点试验，以提高参与者对研究的可接受性/可行性 程序，并进行离职面谈，以评估应用程序的外观，感觉和功能组件。 概念模型。LifeSkills移动的是一项移动健康干预措施，旨在促进生物行为艾滋病毒预防 战略的基础上赋权理论，并制定了基于社区的参与性研究 approach.研究设计概述。我们建议进行一项随机试验，以评估生活技能的成效 在线招募的5，000名YTW中，移动的干预与标准护理（SOC）条件的比较。 主要结局是减少HIV感染事件;次要结局是完全无避孕套肛门/肛门。 在PrEP保护不足的情况下发生阴道性行为。基线时和每6个月 在48个月内，注册的参与者将完成一项在线调查，该调查通过链接发送到他们的移动的手机上 并将邮寄一个OraQuick家庭艾滋病毒检测试剂盒。我们还将估算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，对与SOC相关的生活技能移动的干预进行评估。真实的 世界适用性。鉴于面对面、以群体为基础的信息广泛传播的固有局限性， LifeSkills移动的通过开发移动的 版本，并提供有关当前生物行为预防技术的内容和访问权限（例如，PrEP）。

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).