Evaluating the Feasibility and Acceptability of a Latino MSM Focused PrEP Uptake Intervention

项目摘要：艾滋病毒的差异在与男性发生性关系的拉丁美洲男性（MSM）中持续存在，特别是 那些移民。疾病预防控制中心估计，拉丁美洲男男性行为者的终生艾滋病毒风险为五分之一，而拉丁美洲男男性行为者为五分之一。 白色男男性接触者11例。暴露前预防（PrEP）是一种有效预防艾滋病毒的生物医学策略 获得，有可能减少美国拉丁裔男男性行为者中新的艾滋病毒感染人数。 包括每天一次的药物给药。FDA已经批准了两种药物， 将Truvada®和Descovy®命名为日常使用的PrEP。疾病控制和预防中心 (CDC)制定了向高风险候选人提供PrEP的临床指南。虽然有证据 表明PrEP的使用在美国正在上升，在拉丁美洲男同性恋者之间的吸收差异持续存在，尽管他们 报告了使用PrEP的高度兴趣。为了解决这种差异，我们提出了一个两阶段的项目， 制定一项名为Estoy PrEParado（我是PrEPared）的试点PrEP干预措施，以促进启动和遵守 在拉丁裔男男性接触者中开展预防措施该项目将制定一项有吸引力的、针对文化的干预措施 信息动机行为技能（IMB）模型该项目的具体目标是：目标1： 根据先前研究的数据，该项目将征求反馈，验证和修改最初的 Estoy PrEParado干预的内容领域，以促进PrEP的采用和移民之间的遵守 拉丁裔男男性行为者;目标2：该项目将进行一项小型随机试点Estoy PrEParado， 可行性，可接受性和初步的影响，在移动移民拉丁美洲男男性接触者沿着 PrEP级联至启动。在形成阶段1，该项目将使用创新且新颖的World Café 方法，以促进与移民LMSM的社区对话（n = 40），以验证，修改和完善 Estoy PrEParado试点干预的初始干预内容领域。世界咖啡馆是一个强大的 促进建设性小组对话的对话过程，产生的想法和知识， 付诸实践。该项目还将征求一个非政府组织对干预措施内容的反馈意见和投入， 由学术和社区专家组成的项目特定干预咨询委员会（IAC）。在 第二阶段，该项目将进行一个小型随机试点，80名参与者（40名参与者接受PrEP 干预和40名接受标准护理的参与者，即，PrEP转介）以确定可行性， 可接受性和初步影响。如果干预显示出希望，则研究结果将支持准备 一个更大规模的R 01疗效试验。

PROJECT ABSTRACT: HIV disparity persist among Latino men who have sex with men (MSM), especially those who are immigrants. The CDC estimates the lifetime HIV risk is 1 in 5 for Latino MSM compared to 1 in 11 for white MSM. Pre-Exposure Prophylaxis (PrEP) is a biomedical strategy highly effective in preventing HIV acquisition, with the potential to reduce the number of new HIV infections among Latino MSM in the U.S. PrEP involves once daily dosing of medications. The FDA has approved two medications, sold under the brand names Truvada® and Descovy® for daily use as PrEP. The Centers for Disease Control and Prevention (CDC) has established clinical guidelines for administering PrEP to high-risk candidates. While evidence indicates that PrEP use is rising in the U.S., disparities persist in uptake among Latino MSM, despite their reported high levels of interest in using PrEP. To address this disparity, we propose a 2-phase project to develop a pilot PrEP intervention called Estoy PrEParado (I'm PrEPared) to facilitate initiation and adherence to PrEP among immigrant Latino MSM. The project will develop an engaging, culturally tailored intervention using the Information-Motivation-Behavioral Skills (IMB) model. The specific aims of the project are: Aim 1: based on data from a prior study, the project will elicit feedback, validation and modification to the initial content areas of the Estoy PrEParado intervention to facilitate PrEP adoption and adherence among immigrant Latino MSM; and Aim 2: the project will conduct a small randomized pilot of Estoy PrEParado to assess the feasibility, acceptability and preliminary impact of the intervention in moving immigrant Latino MSM along the PrEP cascade to initiation. In formative phase 1, the project will use the innovative and novel World Café approach to facilitate a community conversation with immigrant LMSM (n≈40) to validate, modify and refine the initial intervention content areas of the Estoy PrEParado pilot intervention. The World Café is a powerful conversational process for facilitating constructive group dialogue that produces ideas and knowledge that can be put into practice. The project will also elicit feedback and input on the contents of the intervention from a project-specific Intervention Advisory Committee (IAC) comprised of academic and community experts. In phase 2, the project will conduct a small randomized pilot of 80 participants (40 participants receiving the PrEP intervention and 40 participants receiving standard care, i.e., PrEP referrals) to establish feasibility, acceptability and preliminary impact. If the intervention shows promise, the findings will support the preparation of a larger scale R01 efficacy trial.