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

项目摘要/摘要 变性人妇女(TGW)是全世界艾滋病毒感染率最高的人群 美国(美国)，2015-2019年新诊断病例数量不断增加。三种类型的预曝光 预防(PrEP)已被证明在TGW中非常有效，但在这一人群中的摄取率仍然很低。 TGW在接受和使用PrEP方面面临许多障碍，包括服用PrEP和 激素药片，对服用PrEP时性别肯定激素疗效降低的担忧，以及担忧 除其他障碍外，PrEP仅适用于与男性发生性行为的男性(MSM)。这些障碍中的许多 可以通过补充信息或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；南非顺性女性的PrEP决策辅助工具 PrEP摄取率翻倍。我们正在调整这个工具(MyPrEP)，以便在美国英语和西班牙语的TGW中使用。 然而，TGW在启动PrEP时可能需要额外的帮助；因此，我们将MyPrEP与我们的 双向短信沟通工具(PrEPmate)，首个CDC认可的循证PrEP支持工具 在年轻的MSM中，PrEP依从性增加了一倍。PrEPmate已经被改编成TGW，但PrEP 该工具的导航组件尚未完全纳入解决以下问题的一些社会决定因素 健康是使用PrEP的TGW的障碍。因此，在目标1中，我们将探索不同PrEP的特点 对TGW最有价值的模式，并检查可能构成障碍的社会决定因素 通过使用形成性研究，参与PrEP。我们将在TGW组织6个焦点小组(3个英语小组， 3个西班牙语，每个5-7个TGW)，并为TGW与8-10个PrEP提供商进行访谈，以探索这些 主题。然后，在目标2中，我们将MyPrEP面向患者的决策支持工具改编为英文-和 使用迭代焦点小组的西班牙语TGW(英语2个，西班牙语2个，每个5-7个TGW)。这些焦点 小组将在3个月内举行3次会议，为TGW的MyPrEP网站提供投入，并确保 在文化和语言上都适合说英语和西班牙语的人。最后，在目标3中，我们将 进行一项先导随机对照试验，随机接受MyPrEP和TGW的联合治疗 PrEPmate(MyPrEP Plus)和20名随机接受对照条件的患者(请访问PEREPREPME.org网站)。 RCT将评估MyPrEP Plus使用的可行性(通过使用两个组件工具进行衡量)和 比较MyPrEP Plus的可接受性和PrEP的接受度和PrEP摄取量与请准备好的.org。在结束时， MyPrEP Plus研究，我们将针对英语和西班牙语TGW调整MyPrEP Plus，并将 确定它是否有足够的承诺推进到TGW的全动力、多站点RCT，以 评估其对PrEP摄取、依从性和持久性的影响。

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.