Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence among At-Risk Transgender Women

开发并试点测试适应性干预措施，以促进高危跨性别女性对 PrEP 的吸收并最大限度地提高 PrEP 的依从性

• 批准号: 10082543
• 负责人: Katie Brooks Biello
• 金额: $ 21.86万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-15 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10082543
• 关键词: AIDS prevention; Address; Adherence; Advisory Committees; Affect; Alcohol or Other Drugs use; Behavior; Behavioral; Birth; Blood drug level result; Caring; Case Management; Centers for Disease Control and Prevention (U.S.); Cognitive; Cognitive Therapy; Communities; Counseling; Data; Enrollment; Exposure to; Face; Feasibility Studies; Feminine; Future; Gender; General Population; Goals; Grant; Guidelines; HIV; HIV Infections; Health; Healthcare; Hospitals; Hour; Incidence; Insurance; Insurance Coverage; Intervention; Intervention Studies; Intervention Trial; Interview; Knowledge; Laboratories; Lead; Maintenance; Methods; Modeling; Motivation; Participant; Patient Self-Report; Persons; Pharmaceutical Preparations; Population; Prevalence; Preventive service; Procedures; Process; Protocols documentation; Randomized; Randomized Controlled Trials; Research; Research Personnel; Resources; Risk; Schedule; Self Efficacy; Service delivery model; Services; Source; Structure; Technology; Testing; Text Messaging; Time; Treatment Efficacy; Universities; Virus; Visit; Woman; Work; adaptive intervention; arm; base; behavioral economics; cisgender; design; empowerment; ethnic diversity; gender minority; high risk; high risk population; male; meetings; member; men; motivational enhancement therapy; peer; pill; pilot trial; pre-clinical; pre-exposure prophylaxis; primary outcome; programs; psychosocial; racial and ethnic; sex; sexual identity; skills; social; social cognitive theory; social disadvantage; social stigma; standard of care; theories; tool; transgender; transgender women; uptake

PROJECT SUMMARY BACKGROUND. PrEP has dramatically changed the promise of HIV prevention, particularly for transgender women (TGW) who are among the highest risk group for HIV in the U.S. While PrEP reduces HIV acquisition by >90% with adequate adherence, TGW face multiple transgender-specific barriers with PrEP access, uptake, adherence, and retention. The PIs have longstanding partnerships with community-based organizations that provide gender-affirming services to this group in Providence, RI and operate one of the first clinical PrEP programs in the U.S., led by our team at Miriam Hospital/Brown University. CONCEPTUAL MODEL. The intervention package (“PrEP N’ Shine”) is based on over a decade of formative and programmatic work grounded in the social-cognitive and contextual realities of high-risk TGW, and as such, the conceptual model underlying the intervention draws on Empowerment Theory and Social Cognitive Theory. The “PrEP N’ Shine” package includes two separate but complementary interventions: 1) peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake; and 2) a resource-efficient, adaptive “stepped-care” technology and counseling intervention to optimize PrEP adherence. “Stepped-care” is a healthcare delivery model in which the least resource intensive part of an intervention is delivered first, and only those who continue to have problems adhering to PrEP receive the more resource-intensive components. APPROACH. Initially, we will continue to work with community members and a community advisory board to further inform the “PrEP N’ Shine” intervention (Aim 1a). Next, we will iteratively refine the intervention, in an open pilot trial with exit interviews, with up to 10 TGW to enhance participant acceptability, feasibility of study procedures, and finalize study protocols (Aim 1b). For Aim 2, we will conduct a pilot randomized controlled trial (RCT) of the “PrEP N’ Shine” intervention using a 2-stage randomization design: For Stage 1, we aim randomize 106 TGW who are candidates for PrEP to receive either the peer-led SBCM for PrEP linkage and uptake or standard of care (SOC; i.e., PrEP referrals only). For Stage 2, those from Stage 1 who initiate PrEP (n~44), regardless of their randomization condition, will then be equally re-randomized to either the resource-efficient, adaptive “stepped-care” intervention to optimize PrEP adherence (initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and then those continuing to have poor adherence will receive the 4 more intensive counseling sessions) or the SOC condition. Primary outcomes include PrEP linkage and uptake; PrEP adherence (both biomedical and self-report assessments); and retention in PrEP care. INNOVATION. The “PrEP N’ Shine” intervention is highly scalable and sustainable in the real world, as it takes into account the “future of PrEP access,” while simultaneously 1) addressing the barriers surrounding access, 2) aiding in navigating linkage, and for those who need it, both insurance and free PrEP program options, and 3) reducing barriers to, and building skills to support, PrEP adherence (once TGW have access to PrEP).

项目总结 背景资料。PREP极大地改变了预防艾滋病毒的承诺，特别是对变性人来说 女性(TGW)是美国艾滋病毒的高危群体之一，而PrEP减少了艾滋病毒的获得 到90%，如果有足够的依从性，TGW在PrEP的获取、吸收、 坚守和保留。私人投资机构与以社区为基础的组织建立了长期的合作伙伴关系， 在RI的普罗维登斯为这一群体提供性别确认服务，并运营首批临床PrEP之一 在美国的项目，由我们在米里亚姆医院/布朗大学的团队领导。概念模型。这个 干预方案(“PrEP N‘Shine”)是基于十多年的形成性和程序性工作 基于高风险TGW的社会认知和背景现实，因此，概念模型 在干预的背后，借鉴了授权理论和社会认知理论。《PrEP N‘Shine》 一揽子计划包括两个独立但互补的干预措施：1)同行主导、基于优势的案例 用于PrEP联系和吸收的管理(SBCM)；和2)资源高效、适应性强的“分步护理” 技术和咨询干预，以优化PrEP依从性。“阶梯式护理”是一种医疗服务。 首先提供干预的资源密集度最低的部分的模式，并且只有那些 继续有问题的坚持PrEP接收更多的资源密集型组件。进场。 最初，我们将继续与社区成员和社区咨询委员会合作，以进一步告知 “PrEP N‘Shine”干预(目标1a)。接下来，我们将在开放的试点试验中反复改进干预措施 通过离职面谈，最多10个TGW，以提高参与者的接受度、研究程序的可行性，以及 最后确定研究方案(目标1b)。对于目标2，我们将进行一项试点随机对照试验 采用两阶段随机化设计的“PrEP N‘Shine”干预：对于第一阶段，我们的目标是随机化106个TGW 谁是PrEP的候选者，接受同行领导的SBCM以进行PrEP链接和吸收，或者接受 CARE(SOC；即仅限PrEP转诊)。对于阶段2，阶段1中发起PrEP的人员(n~44)，无论 他们的随机化条件，然后将被同等地重新随机化到资源高效、自适应的 “分步护理”干预，以优化PrEP依从性(最初，TGW在该手臂将接受每日双向治疗 确认性别的短信提醒，然后那些继续坚持不佳的人将收到4 更密集的咨询会议)或SOC情况。主要结果包括PrEP关联和 摄取；PrEP依从性(生物医学和自我报告评估)；以及PrEP护理中的保留。 创新。“PrEP N‘Shine”干预在现实世界是高度可扩展和可持续的，因为它需要 考虑到“PrEP接入的未来”，同时1)解决围绕接入的障碍， 2)帮助导航链接，并为需要它的人提供保险和免费PrEP计划选项，以及 3)减少遵守PrEP的障碍，并培养支持PrEP的技能(一旦TGW能够获得PrEP)。