Mobile Adaptation and Testing of a Uniquely Targeted HIV Intervention for Young Transgender Women

这项拟议研究的目标是适应“生活技能”-一个有效的和独特的目标群体- 为16-29岁有艾滋病毒风险的年轻变性妇女（YTW）提供基于艾滋病毒预防的干预措施 传输或采集-到移动的平台;并且一旦适应，就进行全面的随机化 对照试验（RCT），以确定其在降低艾滋病毒风险行为方面的疗效。在美国，YTW是一把钥匙 艾滋病毒感染的高风险人群，美国城市YTW中的艾滋病毒流行率估计为 19- 22%。有证据表明，社会经济边缘化和相关的心理社会共同- 发病率驱动高水平的艾滋病毒相关风险YTW，表明需要全面的艾滋病毒预防 针对其独特情况和脆弱性的方案。到目前为止，还没有证据表明 YTW的艾滋病毒预防干预措施（EBI）列在CDC的EBI汇编中;干预措施包括 需要广泛扩展到实践环境。我们将通过以下方式解决这一差距 研究目标：1）使生活技能适应移动的网络平台，包括1a）修订和更新 生活技能干预，包括扩大的艾滋病毒生物医学预防和治疗模式（例如，PrEP 和艾滋病毒治疗作为预防）; 1b）调整干预内容，使之适合移动的部署， 通过定性焦点小组，以用户为中心，在每个入组研究中心建立更大的研究团队和YTW 设计会议和可用性测试。2)对经过调整的移动的干预措施进行试点测试，以提高可行性 40名16-29岁的YTW有HIV感染或传播风险（10名参与者/研究中心） 并准备全面实施。3)测试移动的生活技能干预在以下方面的有效性： 与延迟干预对照组的主要结局比较：无安全套性交次数 行为（肛门和阴道; 4个月召回）没有保护的PrEP/ART;和次要结局： 艾滋病毒/性传播感染（泌尿生殖道/肛门衣原体和淋病、梅毒）。此外，我们将：3a） 通过干预措施的概念性调解人，研究干预组之间艾滋病毒风险的调解： 跨性别适应/融合，集体自尊/赋权，信息，动机， 行为技能3b）与对照组相比，评估移动的生活技能干预的有效性 艾滋病毒预防和护理连续性成果的条件，包括PrEP/艾滋病毒护理联系， 启动和保留，并通过HIV状态（实验室确认）评估效果改变。

The goals of this proposed study are to adapt “LifeSkills”- an efficacious and uniquely targeted group- based HIV prevention intervention for young transgender women (YTW) ages 16-29, at risk for HIV transmission or acquisition- to a mobile platform; and once adapted, to conduct a full-scale randomized controlled trial (RCT) to determine its efficacy in decreasing HIV risk behavior. In the U.S., YTW are a key population at high risk of HIV infection, with HIV prevalence estimates in U.S. among urban YTW ranging from 19-22%. Evidence suggests that socioeconomic marginalization, and related psychosocial co- morbidities drive high levels of HIV-related risk YTW, indicating a need for comprehensive HIV prevention programs targeted to their unique circumstances and vulnerabilities. To date there are no evidence-based HIV prevention interventions (EBIs) for YTW listed in the CDC compendium of EBIs; interventions are needed that are widely scalable to the practice environment. We will address this gap via the following study aims: 1) adapting LifeSkills to a mobile web-based platform, including 1a) revising and updating the LifeSkills intervention to include expanded biomedical HIV prevention and treatment modalities (e.g., PrEP and HIV Treatment as Prevention); 1b) adapting the intervention content for mobile deployment with the larger investigative team and YTW at each enrollment site via qualitative focus groups, user-centered design sessions, and usability testing. 2) Pilot testing the adapted mobile intervention to enhance feasibility and acceptability with 40 YTW ages 16-29 at-risk of HIV acquisition or transmission (10 participants/site) and prepare for full implementation. 3) Testing the efficacy of the mobile LifeSkills intervention in comparison to a delayed intervention control group on the primary outcome: number of condomless sex acts (anal and vaginal; 4-month recall) without protection of PrEP/ART; and secondary outcome: acquisition of HIV/STIs (urogenital/anal chlamydia and gonorrhea, syphilis). Furthermore, we will: 3a) examine mediation in HIV risk between intervention groups by the conceptual mediators of the intervention: transgender adaptation/integration, collective self-esteem/empowerment, information, motivation, and behavioral skills. 3b) assess the efficacy of the mobile LifeSkills intervention in comparison to the control condition on outcomes across the HIV prevention and care continuum, including PrEP/HIV care linkage, initiation, and retention, with assessment of effect modification by HIV status (lab-confirmed).