Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM

描述(由申请人提供)：西班牙裔男男性行为者(HMSM)在全国和迈阿密大都市统计区(MSA)都受到艾滋病毒流行病的严重影响。尽管迫切需要，但很少有基于理论的、文化上合适的行为干预措施来减少男男性接触者中艾滋病毒的性感染或传播风险，并进行了严格的测试。我们的团队一直在从事基于社区的男男性接触者艾滋病毒预防研究(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，我们建议在此应用程序中测试其初步疗效。Proyecto SOL是一种理论上的、基于文化的、群体层面的干预措施，旨在降低HMSM中艾滋病毒感染或传播的风险，有两个版本：SOL-I(针对HIV血清状态为阴性或未知的HMSM)和SOL-II(针对HIV阳性的HMSM)。在这项申请中，我们建议参与一项倡议，以检查针对HMSM的承诺行为干预的初步效果，该干预包括协作和现场特定组件。在项目的初始阶段，我们将召集6至8个重点小组，并进行2至3次“演练”，以最终确定Proyecto Sol的两个版本(包括手册)。我们将最终确定特定地点的评估；对ACASI进行计划和试验台测试，培训工作人员等。在此阶段，我们还将与多地点研究小组合作，制定一套核心评估项目，控制干预措施(待定-控制)，定义招聘程序等，并完成与该计划相关的额外活动。在第二年和第三年，我们将进行两个平行的随机对照试验(RCT)，以确定每个版本的Proyecto Sol与待定对照的初步疗效、可接受性和可行性。在我们过去的研究中，我们将测试与HMSM的风险和保护直接相关的关键因素(文化取向、种族主义、性控制感和内在性负性)是否会影响干预效果。对于研究1，我们将招募120名血清状态阴性或未知的HMSM，并随机将他们分配到SOL-I或待定对照组。对于研究2，我们将招募120名HIV阳性的HMSM，并随机将他们分配到SOL-II或待定对照组。虽然我们建议在社区和互联网场所招聘这两项研究，但关于招聘方法的最终决定将通过合作做出。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一次干预会议之后完成。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，出席会议，编写手稿，在地方、国家和国际会议上介绍情况，以及与倡议有关的其他工作。

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.