Proyecto SOL: A Risk Reduction Intervention for Hispanic MSM

Proyecto SOL：针对西班牙裔 MSM 的风险降低干预措施

• 批准号: 7231145
• 负责人: MARIA ISABEL FERNANDEZ
• 金额: $ 29.63万
• 依托单位: NOVA SOUTHEASTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2009-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7231145
• 关键词: AIDS education /prevention; HIV infections; Hispanic Americans; behavioral /social science research tag; clinical research; clinical trials; cooperative study; group therapy; health disparity; high risk behavior /lifestyle; homosexuals; human subject; human therapy evaluation; information dissemination; male; safe sex /sex abstinence; sex behavior; therapy design /development

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.

描述（由申请人提供）：西班牙裔男男性行为者 (HMSM) 受到艾滋病毒流行的严重影响，无论是在全国范围内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、文化上适当的行为干预措施来降低 HMSM 中性感染或传播艾滋病毒的风险，并经过严格测试。我们的团队一直与 HMSM 一起从事基于社区的艾滋病毒预防研究（R01-DA-16026；R01 MH-62700；U-R3-CCU-41644），这为 Proyecto 课程草案的开发提供了信息 SOL，我们建议在此应用中测试其初步功效。 Proyecto SOL 是一种有理论依据、以文化为基础的群体层面干预措施，旨在降低 HMSM 中 HIV 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）。在此应用中，我们建议参与一项计划，以检查有希望的 HMSM 行为干预措施的初步功效，该干预措施具有协作和特定于场地的组成部分。在项目的初始阶段，我们将召集6-8个焦点小组并进行2至3次“演练”，以最终确定Proyecto SOL的两个版本（包括手册）。我们将完成针对具体地点的评估；在此阶段，我们还将与多地点研究小组合作开发核心评估项目集、控制干预（TBD-CONTROL）、定义招聘程序等，并完成与该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 Proyecto SOL 与 TBD-CONTROL 相比每个版本的初步功效、可接受性和可行性。在我们过去的研究中，我们将测试与 HMSM 风险和保护直接相关的关键因素（文化取向、种族主义、性控制观念和内在同性消极）是否会调节干预效果。对于研究 1，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-I 或 TBD-CONTROL。对于研究 2，我们将招募 120 名 HIV 阳性 HMSM，并将他们随机分配到 SOL-II 或 TBD-CONTROL。尽管我们建议在社区和互联网场所招募这两项研究，但有关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。每次干预会议后将完成可接受性和可行性评估。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相关的其他工作。