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: 10414059
• 负责人: Katie Brooks Biello
• 金额: $ 21.19万
• 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 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10414059
• 关键词: AIDS prevention; Address; Adherence; Advisory Committees; Affect; 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; Text Messaging; Time; Treatment Efficacy; Universities; Virus; Visit; Woman; Work; adaptive intervention; arm; base; behavioral economics; cis-male; design; empowerment; ethnic diversity; gender minority; high risk; high risk population; internalized stigma; male; meetings; member; motivational enhancement therapy; peer; pill; pilot test; 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; substance use; 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).

项目概要 背景。 PrEP 极大地改变了艾滋病毒预防的承诺，特别是对于跨性别者 女性 (TGW) 是美国艾滋病毒感染风险最高的群体之一，而 PrEP 可以减少艾滋病毒感染 超过 90% 的人有足够的依从性，TGW 在 PrEP 获取、采用、 坚持和保留。 PI 与社区组织建立了长期合作伙伴关系， 为罗得岛州普罗维登斯的这一群体提供性别肯定服务，并运营第一个临床 PrEP 之一 由我们在米里亚姆医院/布朗大学的团队领导的美国项目。概念模型。这 干预方案（“PrEP N’ Shine”）基于十多年的形成性和规划性工作 植根于高风险 TGW 的社会认知和背景现实，因此，概念模型 干预的基础借鉴了赋权理论和社会认知理论。 “PrEP N’ Shine” 一揽子计划包括两项独立但互补的干预措施：1）同行主导、基于优势的案例 PrEP 连接和吸收的管理 (SBCM)； 2) 资源高效、适应性强的“阶梯式护理” 技术和咨询干预，以优化 PrEP 依从性。 “阶梯式护理”是一种医疗保健服务 模型中，首先提供干预措施中资源最少的部分，并且只有那些 继续在坚持 PrEP 方面遇到问题，接受资源密集型的组件。方法。 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，我们将在公开试点中迭代完善干预措施 进行退出面谈，最多 10 TGW，以提高参与者的可接受性、研究程序的可行性，以及 最终确定研究方案（目标 1b）。对于目标 2，我们将进行一项试点随机对照试验 (RCT) 使用 2 阶段随机化设计的“PrEP N’ Shine”干预：对于第 1 阶段，我们的目标是随机化 106 TGW 谁是 PrEP 候选人，接受同行主导的 SBCM 以进行 PrEP 联系和采用，或者接受 PrEP 标准 护理（SOC；即仅限 PrEP 转诊）。对于第 2 阶段，来自第 1 阶段的启动 PrEP 的人员 (n~44)，无论 然后，它们的随机化条件将被同等地重新随机化为资源高效、自适应的 “阶梯式护理”干预，以优化 PrEP 依从性（最初，该组中的 TGW 将接受每日 2 种治疗） 确认性别的短信提醒，然后那些仍然坚持不良的人将收到 4 更密集的咨询课程）或 SOC 状况。主要结果包括 PrEP 关联和 吸收； PrEP 依从性（生物医学和自我报告评估）；和保留 PrEP 护理。 创新。 “PrEP N’ Shine”干预措施在现实世界中具有高度可扩展性和可持续性，因为它需要 考虑到“PrEP 获取的未来”，同时 1) 解决获取方面的障碍， 2) 帮助建立联系，并为有需要的人提供保险和免费 PrEP 计划选项，以及 3) 减少 PrEP 依从性障碍并培养支持 PrEP 依从性的技能（一旦 TGW 能够获得 PrEP）。