MyPrEP Plus: Development and Pilot Testing of Novel Pre-Exposure Prophylaxis Support Tools for Transgender Women

MyPrEP Plus：针对跨性别女性的新型暴露前预防支持工具的开发和试点测试

• 批准号: 10618102
• 负责人: Susan Buchbinder
• 金额: $ 52.19万
• 依托单位: PUBLIC HEALTH FOUNDATION ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-07 至 2025-09-06
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10618102
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; African American; Behavioral; Black race; Client satisfaction; Communication; Communication Tools; Contraceptive Agents; Coupled; Decision Aid; Decision Making; Development; Drug Interactions; Eligibility Determination; Enrollment; Ensure; Epidemic; Evaluation; Evidence based intervention; Face; Fatigue; Focus Groups; Fumarates; HIV; HIV Infections; High Prevalence; Hormones; Injectable; International; Intervention; Interview; Knowledge; Language; Latinx; Linguistics; Literature; Measures; Methods; Modality; Modeling; Motivation; Newly Diagnosed; Participant; Patients; Pharmaceutical Preparations; Population; Prevalence; Process; Provider; Randomized; Randomized, Controlled Trials; Regimen; Reporting; Research; Services; Site; South Africa; Tenofovir; Testing; Time; United States; Work; cis-female; efficacy trial; emtricitabine; evidence base; gender affirming hormones; improved; informant; iterative design; meetings; men who have sex with men; novel; pill; pilot test; pre-exposure prophylaxis; preference; provider-level barriers; satisfaction; skills; social determinants; social health determinants; support tools; tool; transgender women; treatment choice; two way texting; uptake; web site; web-based tool; young men who have sex with men

Project Summary/Abstract Transgender women (TGW) are the population with the highest prevalence of HIV infection in the United States (US), with increasing numbers of new diagnoses from 2015-2019. Three types of pre-exposure prophylaxis (PrEP) have been shown to be highly effective in TGW, but uptake remains low in this population. TGW face a number of barriers in taking up and staying on PrEP, including pill fatigue from taking PrEP and hormone pills, concerns about reduced efficacy of gender-affirming hormones when taking PrEP, and concerns that PrEP works only for men who have sex with men (MSM), among other barriers. Many of these barriers could be alleviated by additional information or by choice of a different regimen. Decision support tools can be a useful adjunct to patient-led decision-making; a PrEP decision aid for cis-gender women in South Africa doubled PrEP uptake. We are adapting this tool (MyPrEP) for use in US English- and Spanish-speaking TGW. However, TGW likely need additional help in starting PrEP; therefore, we are combining MyPrEP with our bidirectional SMS communication tool (PrEPmate), the first CDC-endorsed evidence-based PrEP support tool shown to double PrEP adherence in young MSM. PrEPmate has already been adapted for TGW, but the PrEP navigation component of the tool has not fully incorporated addressing some of the social determinants of health that are barriers for TGW using PrEP. Therefore, in Aim 1, we will explore features of different PrEP modalities that are of greatest value to TGW and examine social determinants that may pose barriers to engaging in PrEP, through the use of formative research. We will conduct 6 focus groups in TGW (3 in English, 3 in Spanish, 5-7 TGW each) and conduct interviews with 8-10 PrEP providers for TGW, to explore these themes. Then, in Aim 2, we will adapt the MyPrEP patient-facing decision support tool for English- and Spanish-speaking TGW using iterative focus groups (2 in English, 2 in Spanish, 5-7 TGW each). These focus groups will meet 3 times over 3 months to provide input into the MyPrEP website for TGW, and to ensure it is culturally and linguistically appropriate for both English- and Spanish-speakers. Finally, in Aim 3, we will conduct a pilot randomized controlled trial with 40 TGW randomized to receive the combination of MyPrEP with PrEPmate (MyPrEP Plus), and 20 randomized to receive the control condition (pleaseprepme.org website). The RCT will evaluate the feasibility of MyPrEP Plus use (measured by use of both component tools) and compare the acceptability and PrEP uptake of MyPrEP Plus versus pleaseprepme.org. At the end of the MyPrEP Plus studies, we will have adapted MyPrEP Plus for English- and Spanish-speaking TGW, and will determine whether it holds enough promise to move forward into a fully powered, multi-site RCT in TGW to assess its impact on PrEP uptake, adherence, and persistence.

项目概要/摘要 跨性别女性（TGW）是世界上艾滋病毒感染率最高的人群 美国（US），2015-2019 年新诊断数量不断增加。预曝光的三种类型 预防 (PrEP) 已被证明对 TGW 非常有效，但该人群的使用率仍然较低。 TGW 在接受和继续使用 PrEP 方面面临许多障碍，包括因服用 PrEP 而产生的药物疲劳和 激素药丸、对服用 PrEP 时性别确认激素功效降低的担忧以及担忧 除其他障碍外，PrEP 仅适用于男男性行为者 (MSM)。其中许多障碍 可以通过补充信息或选择不同的治疗方案来缓解。决策支持工具可以是 以患者为主导的决策的有用辅助手段；为南非顺性别女性提供 PrEP 决策援助 PrEP 摄取量增加一倍。我们正在调整此工具 (MyPrEP)，以便在美国英语和西班牙语 TGW 中使用。 然而，TGW 可能需要额外的帮助来启动 PrEP；因此，我们将 MyPrEP 与我们的 双向短信通信工具 (PrEPmate)，第一个 CDC 认可的基于证据的 PrEP 支持工具 结果表明，年轻 MSM 的 PrEP 依从性提高了一倍。 PrEPmate 已针对 TGW 进行了调整，但 PrEP 该工具的导航部分尚未完全纳入解决某些社会决定因素的问题 健康状况是 TGW 使用 PrEP 的障碍。因此，在目标 1 中，我们将探讨不同 PrEP 的特点 对 TGW 具有最大价值的模式，并审查可能构成障碍的社会决定因素 通过形成性研究参与 PrEP。我们将在 TGW 中开展 6 个焦点小组（3 个为英语， 3 个西班牙语，每个 5-7 个 TGW），并与 8-10 个 TGW 的 PrEP 提供者进行访谈，以探索这些 主题。然后，在目标 2 中，我们将调整 MyPrEP 面向患者的决策支持工具，以适应英语和 使用迭代焦点小组的西班牙语 TGW（2 个英语，2 个西班牙语，每个 5-7 个 TGW）。这些重点 小组将在 3 个月内召开 3 次会议，向 TGW 的 MyPrEP 网站提供意见，并确保其 在文化和语言上适合英语和西班牙语使用者。最后，在目标 3 中，我们将 对 40 名 TGW 进行一项试点随机对照试验，随机接受 MyPrEP 与 PrEPmate (MyPrEP Plus)，以及 20 名随机接受对照条件的患者（pleaseprepme.org 网站）。 RCT 将评估 MyPrEP Plus 使用的可行性（通过使用两种组件工具进行测量）和 比较 MyPrEP Plus 与 pleaseprepme.org 的可接受性和 PrEP 吸收率。结束时 MyPrEP Plus 研究，我们将针对讲英语和西班牙语的 TGW 调整 MyPrEP Plus，并将 确定它是否有足够的希望进入 TGW 中的全功能、多站点 RCT，以 评估其对 PrEP 吸收、依从性和持久性的影响。