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

项目摘要/摘要 尽管在过去的30年里做出了预防和治疗的努力，拉丁裔男男性行为者(MSM) 继续受到艾滋病毒的不成比例的影响：2010-2014年间，确诊病例比 年龄在40岁以下的发病率最高。减少艾滋病毒感染的生物医学干预措施 感染没有蔓延到拉丁裔社区。在美国，近30万拉丁裔有资格感染艾滋病毒 2015年实施了暴露预防(PrEP)，但只有7600人收到了处方。 然而，促使行为改变的一个强大的文化来源一直没有得到充分利用：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 是他们的家人给的。然而，在拉丁裔MSM中还没有测试过以家庭为基础的干预措施来促进PrEP 处于感染艾滋病毒的高危状态。研究表明，尽管拉丁裔MSM经常经历家庭排斥和耻辱 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；这造成了压力 随着时间的推移，家庭关系会重新建立；拉丁裔MSM和他们的兄弟姐妹开始相互依赖 他们会变老。兄弟姐妹通常是终生的社会支持来源，77%的拉丁裔至少有一个兄弟姐妹。 该项目旨在让拉丁裔MSM的兄弟姐妹参与PrEP摄取的开发和交付 并评估让兄弟姐妹参与艾滋病毒生物医学干预的初步效果。 具体目标： (1)开发干预信息，以增加高危拉丁裔MSM中PrEP的使用，这可能是 由他们的兄弟姐妹接生。我们将使用IMB模型构造来创建这些消息。我们将进行 与30对LMSM兄弟姐妹进行深入访谈，以确定与发展和交付 增加PrEP使用率的消息。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)在对拉丁裔MSM及其成员进行的非受控试点研究中实施干预信息 兄弟姐妹(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天的随访 Pair收集可行性和可接受性数据，并根据需要改进报文和交付程序。 (3)进行两组随机对照试验(n=124)，以评价兄弟姐妹分娩的疗效 PREP报文与提供商交付的用于高风险的标准PrEP报文的比较 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简短的干预措施，该干预措施可以由我们的 社区合作伙伴和PrEP卓越中心，圣约翰儿童和家庭中心，并最终 由卫生部门和其他PrEP利益攸关方扩大。未来的研究可能会使这种方法适用于 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.