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

LifeSkills Mobile 数字化、有限互动功效试验可降低年轻跨性别女性的艾滋病毒发病率

• 批准号: 10598468
• 负责人: MARVIN E BELZER
• 金额: $ 207.59万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-09 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10598468
• 关键词: AIDS prevention; Accounting; Address; Adherence; Adult; Affect; Age; Antibodies; Anus; Area; Award; Behavior; Birth; California; Caring; Cellular Phone; Communities; Data; Development; Diagnostic Reagent Kits; Disparity; Economics; Educational Curriculum; Evidence based intervention; Exposure to; Facebook; Feasibility Studies; Feminine; Funding; Gender; Gender Identity; Geography; HIV; HIV Infections; HIV risk; Health Care Costs; Health Care Sector; Healthcare; Home; Human immunodeficiency virus test; Incidence; Intervention; Interview; Knowledge; Laboratories; Letters; Life; Link; Location; Los Angeles; Mediator; Modeling; Motivation; National Institute of Mental Health; Participant; Pediatric Hospitals; Persons; Population; Populations at Risk; Prevalence; Prevention; Prevention strategy; Procedures; Process; Randomized; Randomized, Controlled Trials; Research; Research Design; Research Infrastructure; Research Personnel; Research Support; Resources; Risk; Risk Reduction; Sampling; San Francisco; Screening procedure; Self Efficacy; Sexual Partners; Site; Surveys; Technology; Testing; Time; Treatment Efficacy; Universities; Update; Vagina; Work; acceptability and feasibility; biobehavior; care systems; cohort; community based participatory research; condoms; cost; digital; efficacy evaluation; efficacy testing; efficacy trial; empowerment; experience; gender minority; group intervention; handheld mobile device; health service use; high risk; incremental cost; innovation; mHealth; male; marginalization; mobile application; models and simulation; online delivery; participant enrollment; pilot test; pilot trial; pre-exposure prophylaxis; prevent; preventive intervention; primary outcome; psychosocial; recruit; reproductive; rural area; satisfaction; secondary outcome; self esteem; sex; skills; social disparities; social stigma; sociodemographic variables; socioeconomics; standard of care; substance use; theories; transgender; transgender women; uptake; usability; web app

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).

背景。年轻的变性妇女（YTW）的HIV患病率/发病率最高 在美国，风险群体反复暴露于心理社会的性别少数污名 与社会灾难和经济边缘化相关的挑战加剧了艾滋病毒的分布 发病率并使YTW的性别认同无效。这可能会导致行为（例如，使用物质，性工作， 避免医疗保健）潜在的艾滋病毒收购风险。为了减少YTW中的艾滋病毒事件， 干预需要1）作为YTW生活环境的一部分解决艾滋病毒的风险； 2）可访问和深远的这样的 在最方便的时间内，整个高危人群可以参与（例如粗糙的地区）；和 3）在现实环境中实施的相关成本较低，高度可持续。初步研究。 当前的提案是与该人群进行了十多年研究的高潮，其中包括：1） 开发和试点测试基于授权的，基于赋权的（亲自）艾滋病毒预防干预 YTW年龄16-29岁，称为Project Lifeskills； 2）进行全尺度的多站点随机对照试验 （RCT）Lifeskills（NIMH R01； MPI：Garofalo/Mimiaga），我们在其中证明了这一点的效率 降低艾滋病毒风险的干预措施（注意：项目救生员目前是唯一的“最佳证据”艾滋病毒风险降低 CDC的基于循证干预措施的汇编中包括YTW的干预措施）； 3）适应 项目Lifeskills的面对面版本可用于在线交付的移动应用平台（包含4个在线） 模块）通过NIMH资助的R56（MPI：Kuhns，Mimiaga），称为“ Lifeskills Mobile”； 4）完成 Lifeskills移动应用程序的迭代可用性试验试验，以增强研究的参与性可接受性/可行性 程序并进行了退出访谈，以评估应用程序的外观，感觉和功能性组件。 概念模型。 Lifeskills Mobile是一种MHealth干预措施，可促进预防生物行为的HIV 基于授权理论的策略，并使用基于社区的参与研究开发 方法。研究设计概述。我们建议进行RCT来评估Lifeskills的效率 与在线招募的5,000年YTW中的护理标准（SOC）相比，移动干预措施相比。 主要结果是减少了艾滋病毒感染。次要结果是总无糖肛门/ 阴道性行为发生在准备不足的背景下。基线和每6个月 到48个月，入学参与者将完成通过其手机链接发送的在线调查 并将邮寄一个Oraquick在家中的HIV测试套件。我们还将估计 从医疗保健部门和社会角度来看，Lifeskills移动干预相对于SOC。真实的 世界适用性。鉴于对面对面的宽度传播的继承限制 干预措施，Lifeskills Mobile通过移动的开发扩展了干预的潜在影响 版本，并提供当前生物行为预防技术（例如Prep）的内容和访问。