Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM

描述（由申请人提供）：在全国和迈阿密大都会统计区（MSA），与男性发生性关系的西班牙裔男性（HMSM）受到艾滋病毒流行的严重影响。尽管有迫切的需求，但很少有基于理论的、文化上合适的行为干预措施来降低HMSM之间的性感染或艾滋病毒传播的风险，并进行了严格的测试。我们的团队一直在从事以社区为基础的HMSM艾滋病毒预防研究（R01- da -16026; R01 MH-62700; U-R3-CCU-41644），这为Proyecto SOL课程草案的制定提供了信息，我们建议在此应用中测试其初步功效。proyeto SOL是一种以理论为基础，以文化为基础的群体水平干预，旨在降低HMSM感染或传播艾滋病毒的风险，有两种版本：SOL- 1（针对艾滋病毒血清状态为阴性或未知的HMSM）和SOL- ii（针对艾滋病毒阳性的HMSM）。在本申请中，我们建议参与一项倡议，以检查对HMSM有希望的行为干预的初步效果，这些干预包括协作和特定地点的成分。在项目的初始阶段，我们将召集6-8个焦点小组，并进行2 - 3次“演练”，以最终确定proyeto SOL的两个版本（包括手册）。我们将完成具体地点的评估；对ACASI进行程序设计和台架测试，培训员工等。在此阶段，我们还将与多站点研究小组合作，制定核心评估项目，控制干预（TBD-CONTROL），确定招聘程序等，并完成与计划相关的其他活动。在第2年和第3年，我们将进行两项平行随机对照试验（RCT），以确定每个版本的Proyecto SOL与TBD-CONTROL的初步疗效、可接受性和可行性。我们将测试在我们过去的研究中，与HMSM的风险和保护直接相关的关键因素（文化取向、种族主义、性控制观念和内化的同性恋负性）是否会缓和干预效果。在研究1中，我们将招募120名血清状态为阴性或未知的HMSM，并将他们随机分配到sol - 1或TBD-CONTROL组。在研究2中，我们将招募120名HIV阳性的HMSM，随机分配到SOL-II或TBD-CONTROL组。虽然我们建议在社区和互联网场所招募这两项研究，关于招募方法的最终决定将共同做出。使用ACASI的评估将在基线和干预后3个月进行。可接受性和可行性评估将在每次干预后完成。在整个项目期间，我们将继续与多地点研究小组合作，参加预定的电话会议，参加会议，准备手稿，在地方，国家和国际会议上发表演讲，以及其他与该倡议相关的工作。

DESCRIPTION (provided by applicant): Hispanic men who have sex with men (HMSM) have been highly impacted by the HIV epidemic, both nationally and in the Miami metropolitan statistical area (MSA). Despite the urgent need, few theoretically based, culturally appropriate behavioral interventions to reduce risk of sexual acquisition or transmission of HIV among HMSM have been developed and rigorously tested Our team has been engaged in community- based HIV prevention research with HMSM (R01-DA-16026; R01 MH-62700; U-R3-CCU-41644) that informed the development of the draft curricula of Proyecto SOL, whose preliminary efficacy we are proposing to test in this application. Proyecto SOL is a theoretically grounded, culturally based, group level intervention to reduce risk of HIV acquisition or transmission among HMSM with two versions: SOL-I (for HMSM whose HIV serostatus is negative or unknown), and SOL-II (for HMSM who are HIV positive). In this application, we propose to participate in an initiative to examine preliminary efficacy of promising behavioral interventions for HMSM that has both collaborative and site specific components. In the initial phase of project, we will convene 6-8 focus groups and conduct 2 to 3 "dry-runs" to finalize the two versions (including manuals) of Proyecto SOL. We will finalize the site-specific assessment; program and bench test the ACASI, train staff etc. During this phase, we will also work with the multi-site study group to develop the core set of assessment items, control intervention (TBD-CONTROL), define the recruitment procedures etc., and complete additional activities of relevance to the initiative. During Years 2 and 3, we will conduct two parallel randomized control trials (RCT) to determine preliminary efficacy, acceptability, and feasibility of each version of Proyecto SOL compared with the TBD-CONTROL. We will test whether key factors (cultural orientation, racism, perceptions of sexual control, and internalized homonegativity) directly linked to risk and protection among HMSM in our past studies moderate intervention effects. For Study 1, we will recruit 120 HMSM of negative or unknown serostatus and randomly assign them to SOL-I or TBD-CONTROL. For Study 2, we will recruit 120 HIV positive HMSM and randomly assign them to SOL-II or TBD-CONTROL. Although we propose to recruit in community and internet venues for both studies, final decisions regarding recruitment approaches will be made collaboratively. Assessments using ACASI will be done at baseline and 3 months post intervention. Acceptability and feasibility assessments will be completed after each intervention session. Throughout the project period, we will continue to collaborate with the multi-site study group by participating in scheduled conference calls, attending meetings, preparing manuscripts, presenting at local, national and international meetings and other work of relevance to the initiative.