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.

项目总结/摘要 变性妇女是艾滋病毒感染率最高的人口， 美国（US），2015-2019年的新诊断数量不断增加。三种预曝光 已经证明预防性治疗（PrEP）在TGW中非常有效，但在该人群中摄取仍然很低。 TGW在接受和坚持PrEP方面面临许多障碍，包括服用PrEP的药丸疲劳， 激素药丸，对服用PrEP时性别肯定激素疗效降低的担忧， PrEP仅适用于与男性发生性关系的男性（MSM），以及其他障碍。许多这些障碍 可以通过额外的信息或通过选择不同的方案来缓解。决策支持工具可以 患者主导决策的有用辅助工具;南非顺性别妇女的PrEP决策辅助工具 PrEP摄取量翻倍我们正在调整这一工具（MyPrEP）用于美国英语和西班牙语的TGW。 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认可的循证PrEP支持工具 在年轻的MSM中显示出加倍的PrEP依从性。PrEPmate已经适用于TGW，但PrEP 该工具的导航部分没有充分纳入解决一些社会决定因素， 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， 参与PrEP，通过使用形成性研究。我们将在TGW进行6个焦点小组（3个用英语， 3西班牙语，每个5-7 TGW），并与8-10 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， 西班牙语TGW使用迭代焦点小组（2个英语，2个西班牙语，每个5-7 TGW）。这些重点 小组将在3个月内召开3次会议，为TGW的MyPrEP网站提供投入，并确保其 在文化和语言上适合英语和西班牙语使用者。在目标3中，我们将 进行一项初步随机对照试验，其中40名TGW随机接受MyPrEP与 PrEPmate（MyPrEP Plus），20名随机接受对照条件（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）， 比较MyPrEP Plus与pleaseprepme.org的可接受性和PrEP吸收。 MyPrEP Plus研究，我们将为英语和西班牙语TGW改编MyPrEP Plus，并将 确定它是否有足够的希望在TGW中进入一个完全供电的多站点RCT， 评估其对PrEP摄取、依从性和持久性的影响。