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。年轻跨性别女性 (YTW) 的艾滋病毒患病率/发病率高于其他任何女性 美国的危险群体 反复遭受性别少数群体的耻辱，再加上社会心理的影响 与社会弱势和经济边缘化相关的挑战加剧了艾滋病毒方面的差异 发生率并使 YTW 的性别认同无效。这可能会导致行为（例如，物质使用、性工作、 避免医疗保健）会增加艾滋病毒感染风险。为了降低 YTW 中的艾滋病毒感染率， 干预措施需要 1) 将艾滋病毒风险作为 YTW 生活环境的一部分； 2) 具有可及性和深远的影响 所有高危人群（例如农村地区）都可以在最方便的时间参与；和 3）具有高度可持续性，在现实环境中实施的相关成本较低。初步研究。 当前的提案是针对该人群 10 多年研究的结晶，其中包括：1) 开发并试点测试基于赋权、团体提供（亲自）的艾滋病毒预防干预措施 针对 16-29 岁的 YTW，称为 Project LifeSkills； 2) 进行全面、多中心随机对照试验 生命技能项目（NIMH R01；MPIs：Garofalo/Mimiaga）的（随机对照试验），我们证明了该方法的有效性 降低艾滋病毒风险的干预措施（注：生命技能项目是目前降低艾滋病毒风险的唯一“最佳证据” 针对 YTW 的干预措施已纳入 CDC 的循证干预措施纲要）； 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（MPI：Kuhns、Mimiaga），称为“LifeSkills Mobile”； 4) 完成一个 LifeSkills 移动应用程序的迭代可用性试点试验，以提高参与者研究的可接受性/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 Mobile 是一项移动医疗干预措施，旨在促进艾滋病毒生物行为预防 基于赋权理论的策略，是通过基于社区的参与性研究制定的 方法。研究设计概述。我们建议进行随机对照试验来评估 LifeSkills 的功效 在线招募的 5,000 名 YTW 中的移动干预与护理标准 (SOC) 状况的比较。 主要成果是减少艾滋病毒感染事件；次要结果是完全无套肛门/ 在 PrEP 保护不足的情况下发生的阴道性行为。基线时和每 6 个月一次 在 48 个月内，注册参与者将完成通过手机链接发送的在线调查 并将邮寄 OraQuick 家用 HIV 检测试剂盒。我们还将估算总成本和增量成本 从医疗保健部门和社会的角度来看，与 SOC 相关的 LifeSkills 移动干预。真实的 世界适用性。鉴于广泛传播面对面、基于群体的固有局限性 LifeSkills Mobile 通过开发移动设备扩展了干预的潜在范围 版本，并提供当前生物行为预防技术（例如 PrEP）的内容和访问权限。