Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM

描述（由申请人提供）：西班牙裔男性与男性发生性关系（HMSM）受到艾滋病毒流行的高度影响，无论是在全国还是在迈阿密大都市统计区（MSA）。尽管迫切需要，但很少有基于理论的，文化上适当的行为干预措施，以减少HMSM中的性获得或传播艾滋病毒的风险，并进行了严格的测试。（R01-DA-16026; R01 MH-62700; U-R3-CCU-41644），为Proyecto SOL课程草案的开发提供了信息，我们建议在本申请中测试其初步有效性。SOL项目是一项有理论依据、基于文化的群体干预措施，旨在降低HMSM感染或传播艾滋病毒的风险，有两个版本：SOL-I（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）。在这个应用程序中，我们建议参与一项倡议，以检查有前途的行为干预HMSM的初步疗效，既有合作和网站的具体组成部分。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"试运行"，以最终确定Proyecto SOL的两个版本（包括手册）。我们将最终完成研究中心特定评估;对ACASI进行程序和台架测试，培训工作人员等。在此阶段，我们还将与多中心研究小组合作开发核心评估项目集、控制干预（TBD-CONTROL），定义招募程序等，并完成与该倡议有关的其他活动。在第2年和第3年，我们将进行两项平行随机对照试验（RCT），以确定与TBD-对照相比，每个版本的Proyecto SOL的初步疗效、可接受性和可行性。我们将测试是否关键因素（文化取向，种族主义，性控制的看法，和内在的同性恋）直接联系到风险和保护HMSM在我们过去的研究温和的干预效果。对于研究1，我们将招募120例血清状态为阴性或未知的HMSM，并将其随机分配至SOL-I或TBD-对照组。对于研究2，我们将招募120名HIV阳性HMSM，并将其随机分配至SOL-II或TBD-对照组。虽然我们建议在社区和互联网上进行两项研究的招募，但关于招募方法的最终决定将由合作做出。将在基线和干预后3个月使用ACASI进行评估。可接受性和可行性评估将在每次干预会议后完成。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，准备手稿，在地方，国家和国际会议上发言以及与该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.