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

评估以拉丁裔 MSM 为重点的 PrEP 摄取干预措施的可行性和可接受性

• 批准号: 10083014
• 负责人: Ronald Andrew Brooks
• 金额: $ 22.79万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-15 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10083014
• 关键词: AIDS prevention; Address; Adherence; Adopted; Adoption; Advisory Committees; Applications Grants; Area; Attitude; Behavioral; California; Centers for Disease Control and Prevention (U.S.); Charge; Clinical; Communities; Control Groups; Counseling; County; Data; Disclosure; Dose; Effectiveness; Enrollment; Epidemic; Ethnic group; Feedback; Grant; Guidelines; HIV; HIV Infections; HIV diagnosis; HIV risk; Healthcare Systems; Home environment; Human immunodeficiency virus test; Immigrant; Individual; Intervention; Knowledge; Latino; Los Angeles; Medicaid; Medical; Modeling; Modification; Monitor; Motivation; Names; Participant; Pharmaceutical Preparations; Phase; Population; Preparation; Prevention; Prevention strategy; Process; Public Health; Randomized; Reporting; Research; Risk Behaviors; Self Care; Self Efficacy; Services; Site; Social Interaction; Support Groups; Text Messaging; Training; Treatment Efficacy; United States Food and Drug Administration; Validation; base; black men who have sex with men; cost; cultural values; design; efficacy trial; flexibility; high risk; high risk men; innovation; insight; interest; male; men who have sex with men; novel; patient-clinician communication; peer; pre-exposure prophylaxis; prevent; programs; racial and ethnic; risk perception; side effect; skills; social stigma; standard care; truvada; uptake

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.

项目摘要：艾滋病毒差异在拉丁裔男男性行为者 (MSM) 中持续存在，尤其是 那些移民。 CDC 估计拉丁裔男男性接触者终生感染艾滋病毒的风险为五分之一，而这一比例为五分之一。 11 为白色 MSM。暴露前预防 (PrEP) 是一种非常有效预防 HIV 的生物医学策略 获得，有可能减少美国拉丁裔 MSM 中新发 HIV 感染的数量。 涉及每天服用一次药物。 FDA 已批准两种以该品牌销售的药物 将日常使用的 Truvada® 和 Descovy® 命名为 PrEP。疾病控制和预防中心 (CDC) 已制定了对高风险候选人进行 PrEP 的临床指南。虽然有证据 表明 PrEP 在美国的使用正在增加，拉丁裔 MSM 的使用率仍然存在差异，尽管他们 报道称人们对使用 PrEP 非常感兴趣。为了解决这一差距，我们提出了一个分两阶段的项目 开发名为 Estoy PrEParado（我是 PrEPared）的试点 PrEP 干预措施，以促进启动和坚持 移民拉丁裔 MSM 中的 PrEP。该项目将开发一种引人入胜的、针对文化的干预措施 使用信息-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、验证和修改初始方案 Estoy PrEParado 干预措施的内容领域旨在促进移民采用和遵守 PrEP 拉丁裔男男性行为者；目标 2：该项目将进行 Estoy PrEParado 的小型随机试点，以评估 移民拉丁裔男男性接触者沿途的可行性、可接受性和初步影响 PrEP 级联至启动。在第一阶段，该项目将使用创新新颖的世界咖啡馆 促进与移民 LMSM (n≈40) 进行社区对话的方法，以验证、修改和完善 Estoy PrEParado 试点干预的初始干预内容领域。世界咖啡厅实力雄厚 促进建设性小组对话的对话过程，产生可以 付诸实践。该项目还将征求专家对干预内容的反馈和意见 特定项目的干预咨询委员会（IAC）由学术和社区专家组成。在 第 2 阶段，该项目将进行一项由 80 名参与者组成的小型随机试点（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 转诊）以确定可行性， 可接受性和初步影响。如果干预措施显示出希望，研究结果将支持准备工作 更大规模的 R01 功效试验。