Behavioral Research Project:Promoting HIV PrEP among MSM: a Randomized Controlled Trial Protocol

项目总结/摘要 尽管在过去30年的预防和治疗努力，拉丁美洲男子谁与男性发生性关系（MSM） 继续受到艾滋病毒的不成比例的影响：2010-2014年间， 40岁以下发病率最高。艾滋病毒生物医学干预措施，以减少艾滋病毒 感染没有到达拉丁裔社区。全国近30万拉丁美洲人有资格在艾滋病毒感染前 在2015年，只有7，600人获得了暴露预防（PrEP）的处方。 然而，行为改变的一个强大的文化动力来源却没有得到充分利用：家庭。拉丁裔 报告高度依赖家庭的物质和情感支持，并经常选择健康的行为“做 “对，对，对家人。然而，没有以家庭为基础的干预措施，以促进PrEP已在拉丁美洲男男性行为者中进行了测试 艾滋病感染的高危人群虽然拉丁裔男男性接触者经常经历家庭的排斥和耻辱，研究表明， 许多人继续优先考虑家庭对行为改变的支持，而不是其他支持来源; 随着时间的推移，家庭关系重新建立;拉丁裔男男性接触者和他们的兄弟姐妹相互依赖， 他们会变老兄弟姐妹通常是社会支持的终身来源，77%的拉丁美洲人至少有一个兄弟姐妹。 该项目旨在让拉丁裔男男性接触者的兄弟姐妹参与PrEP摄取的开发和交付 信息，并评估让兄弟姐妹参与艾滋病毒生物医学干预措施的初步效果。 具体目标： (1)制定干预信息，以增加PrEP在高风险拉丁裔MSM中的使用， 由他们的兄弟姐妹传递。我们将使用IMB模型构造来创建这些消息。我们会进行 与30个LMSM兄弟姐妹对进行深入访谈，以确定与开发和交付相关的因素， 增加PrEP使用的信息。信息将由专家小组进行评级，并由3个焦点小组进行测试。 (2)在一项针对拉丁裔男男性行为者及其 同胞（n=20对）。我们将使用前/后测试设计，对20名拉丁裔MSM兄弟姐妹进行30天随访 配对收集可行性和可接受性数据，并根据需要完善信息和传递程序。 (3)进行两组随机对照试验（n=124），以评价同胞分娩的疗效 PrEP消息与提供商交付的用于高风险的标准PrEP消息进行比较 拉丁裔男男性接触者 该项目的一个重要目标是开发一种有效和短暂的干预，可以通过我们的 社区合作伙伴和PrEP卓越中心，圣约翰儿童和家庭中心，最终 卫生部门和其他PrEP利益攸关方扩大了规模。未来的研究可以采用这种方法， 其他种族/族裔性和性别少数群体。

Project Summary/Abstract Despite the prevention and treatment efforts of the past 30 years, Latino men who have sex with men (MSM) continue to be disproportionately impacted by HIV: diagnoses increased 14% between 2010-2014 and those younger than 40 years old had the highest incidence rates. HIV biomedical interventions to reduce HIV infections are not reaching Latino communities. Nearly 300,000 Latinos in the nation were eligible for HIV pre- exposure prophylaxis (PrEP) in 2015, yet only 7,600 received a prescription for it. Yet a powerful cultural source of motivation for behavior change has been underutilized: the family. Latinos report a high reliance on family for material and emotional support and often choose healthy behaviors to “do right” by their family. Yet no family-based interventions to promote PrEP have been tested among Latino MSM at high-risk for HIV infection. Although Latino MSM often experience family rejection and stigma, studies show that many continue to prioritize family support for behavior change over other sources of support; that strained family ties are reestablished over time; and that Latino MSM and their siblings come to rely on each other as they age. Siblings are often a lifelong source of social support and 77% of Latinos have at least one sibling. This project aims to engage the siblings of Latino MSM in the development and delivery of PrEP-uptake messages and to evaluate the initial efficacy of involving siblings in HIV biomedical interventions. Specific Aims: (1) To develop intervention messages to increase PrEP use in high-risk Latino MSM that can be delivered by their siblings. We will use IMB model constructs to create these messages. We will conduct in-depth interviews with 30 LMSM-Sibling pairs to identify factors relevant for the development and delivery of messages to increase PrEP-use. Messages will be rated by a panel of experts and tested with 3 focus groups. (2) To implement the intervention messages in an uncontrolled pilot study with Latino MSM and their siblings (n=20 pairs). We will use a pre/post test design with 30-day follow-up with 20 Latino MSM-sibling pairs to gather feasibility and acceptability data, and to refine messages and delivery procedures as needed. (3) To conduct a two-group randomized control trial (n=124) to evaluate the efficacy of sibling-delivered PrEP messages compared with provider-delivered standard PrEP messages for use with high-risk Latino MSM. An important aim of this project is to develop an effective and brief intervention that can be sustained by our community partner and PrEP Center for Excellence, St. John’s Well Child and Family Center, and ultimately scaled-up by health departments and other PrEP stakeholders. Future studies could adapt this approach for other racial/ethnic sexual and gender minorities.