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

项目摘要 背景PrEP极大地改变了艾滋病毒预防的承诺，特别是对跨性别者 女性（TGW）是美国艾滋病毒风险最高的群体之一，而PrEP减少了艾滋病毒感染 通过>90%的充分遵守，TGW面临多种跨性别特定的障碍与PrEP的访问，摄取， 坚持和保留。PI与社区组织建立了长期的伙伴关系， 为普罗维登斯的这一群体提供性别肯定服务，RI并运营首批临床PrEP之一 在美国，由我们在米里亚姆医院/布朗大学的团队领导概念模型。的 干预包（“PrEP N' Shine”）是基于十多年的形成和方案工作 基于高风险TGW的社会认知和背景现实，因此，概念模型 干预的理论基础是授权理论和社会认知理论。“PrEP N' Shine” 一揽子措施包括两个独立但互补的干预措施：1）同行领导，基于优势的案例 预防前预防措施联系和吸收的SBCM; 2）资源高效，适应性的“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， 首先提供干预措施中资源密集程度最低的部分，只有那些 继续有问题坚持PrEP接收更多的资源密集型组件. APPROACH. 最初，我们将继续与社区成员和社区咨询委员会合作， “PrEP N' Shine”干预（目标1a）。接下来，我们将在一个开放的试点试验中反复完善干预措施 与离职面谈，最多10个TGW，以提高参与者的可接受性，研究程序的可行性， 完成研究方案（目标1b）。对于目标2，我们将进行一项初步随机对照试验（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的候选人，接受同行领导的SBCM的PrEP链接和吸收或标准， 护理（SOC;即，仅PrEP转介）。对于第2阶段，那些从第1阶段开始PrEP的人（n~44），无论 然后，它们的随机化条件将被同样地重新随机化为资源有效的、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将接受每日双向 确认性别的短信提醒，然后那些坚持性仍然较差的人将收到4 更密集的咨询会议）或SOC条件。主要成果包括PrEP联系， 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”干预在真实的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）解决围绕获取的障碍， 2)帮助导航链接，对于那些需要它的人，保险和免费的PrEP计划选项，以及 3)减少障碍，并建立技能，以支持，PrEP依从性（一旦TGW获得PrEP）。

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).