Development of a HIV prevention toolkit for at-risk HIV-negative male couples

描述（由申请人提供）：目前的估计表明，在美国，58%至78%的MSM在同性关系的背景下从其主要伴侣那里获得艾滋病毒（例如，男性伴侣）。对男性夫妇的研究审查了哪些因素，包括性协议，影响他们感染艾滋病毒的风险。在美国，许多男性伴侣会形成一个性协议：两个伴侣之间关于在他们的关系内外可能发生的性行为和其他行为的明确协议。从本质上讲，夫妻的性协议对他们感染艾滋病毒和其他性传播疾病的风险有直接影响。由于针对男性夫妇的艾滋病毒预防干预措施很少，因此迫切需要考虑到男性夫妇关系背景的新的和新颖的方法，以大大改善艾滋病毒预防工作。为了帮助填补这一关键空白，拟议的3年研究旨在开发和试点理论推导，基于网络的艾滋病毒预防工具包，用于美国高危艾滋病毒阴性男性夫妇。通过完成模块，交互式艾滋病毒预防工具包将指导和协助目前进行无保护肛交（UAI）的高危艾滋病毒阴性男性伴侣（MSM中感染艾滋病毒的主要性风险行为）形成明确的性协议，其中整合了艾滋病毒和性传播感染的间隔检测以及预防信息，同时独特地满足他们关系的需求。基于网络的预防工具包将包括两个部分：一个互动网站，其中包含理论为基础的模块，供夫妇完成，同时形成他们的协议，和相应的智能手机应用程序（应用程序），将包含一份协议的副本沿着的全球定位系统启用的性健康资源的列表，如在那里他们可以测试艾滋病毒和性传播感染，并获得免费的安全性用品和生物医学预防方法。预防工具包的开发将分三个阶段进行。在第一阶段，我们将在底特律和亚特兰大与30对艾滋病毒阴性的男性夫妇进行个人和夫妇层面的访谈，这些男性夫妇实行UAI，目前有一个性协议（15个开放，15个关闭），以获得有关预防工具包模块内容的反馈，这些模块来自我们以前关于男性夫妇性协议和关系动态的广泛的艾滋病毒预防研究。第一阶段获得的反馈将被整合，以改进模块的内容，并由软件公司用于设计预防工具包的第一版。第二阶段将包括举办两个重点小组，一个在底特律，一个在亚特兰大，由7对艾滋病毒阴性的男性夫妇参加，对单元内容进行试点测试，并就互动练习的吸引力和禁欲主义以及预防工具包的组成部分获得反馈。通过整合第二阶段的调查结果，将在开始试点测试干预措施之前进一步完善预防工具包。对于第3阶段，将通过互联网进行一项为期6个月的小型前瞻性随机对照试验，采用160对高危HIV阴性男性夫妇的全国便利样本，以确定接受干预的夫妇（即，预防工具包）将形成和坚持他们的性协议，增加他们的艾滋病毒和性传播感染的检测率，并避免或减少他们与非正式男男性行为者的UAI发生。拟议的研究是创新的，因为技术被适当地用于最大限度地扩大覆盖面和影响，同时独特地适应每对夫妇的需求。我们预计我们的试点干预措施将显示出降低男性夫妇艾滋病毒风险的希望，然后将通过更大的随机对照试验进一步测试其有效性。

DESCRIPTION (provided by applicant): Current estimates indicate that between 58% and 78% of MSM in the US acquire HIV from their main partners within the context of a same-sex relationship (e.g., male couples). Studies with male couples have examined which factors, including sexual agreements, impact their risk for acquiring HIV. Many male couples in the US form a sexual agreement: an explicit agreement made between two partners about what sexual and other behaviors may occur within and outside of their relationship. By nature, couples' sexual agreements have direct implications toward their risk for HIV and other STIs. Because few HIV prevention interventions exist for male couples, new and novel approaches that consider the relational context of male couples are urgently needed to significantly improve HIV prevention. To help fulfill this critical gap, the proposed 3-year study aims to develop and pilot theoretically derived, web-based HIV prevention toolkit for at-risk HIV-negative male couples in the US. Through the completion of modules, the interactive HIV prevention toolkit will guide and assist at-risk HIV-negative male couples who currently practice unprotected anal intercourse (UAI) - the primary sexual risk behavior for HIV acquisition among MSM - form an explicit sexual agreement that integrates interval testing for HIV and STIs and prevention messaging while uniquely meeting the needs of their relationship. The web-based prevention toolkit will consist of two components: an interactive website that contains theoretically-based modules for couples to complete while forming their agreement, and a corresponding smartphone application (app) that will contain a copy of the agreement along with a list of GPS- enabled sexual health resources, such as where they can test for HIV and STIs, and access free safer sex supplies and biomedical approaches to prevention. Development of the prevention toolkit will occur through 3 phases. In Phase 1, we will conduct individual- and couple-level interviews in Detroit and Atlanta with 30 HIV- negative male couples who practice UAI and currently have a sexual agreement (15 open, 15 closed) to obtain feedback about the content in the prevention toolkit modules, derived from our extensive previous HIV prevention studies about male couples' sexual agreements and relationship dynamics. Feedback obtained from Phase 1 will be integrated to improve the content of the modules, and used by the software company to design the first version of prevention toolkit. Phase 2 will include conducting 2 focus groups, one in Detroit and one in Atlanta, with 7 HIV-negative male couples to pilot test the content of the modules, and obtain feedback about the appeal and ascetics of the interactive exercises and components of the prevention toolkit. By integrating findings from Phase 2, further refinements will be made to the prevention toolkit before beginning to pilot test the intervention. For Phase 3, a small prospective RCT with a 6-month follow-up period will be conducted via the Internet with a national convenience sample of 160 at-risk HIV-negative male couples to determine whether couples who receive the intervention (i.e., prevention toolkit) will form and adhere to their sexua agreement, increase their testing rates for HIV and STIs, and abstain from or decrease their occurrences of UAI with casual MSM partners when compared to couples in the control group. The proposed study is innovative because technology is appropriately used to maximize reach and impact while uniquely tailoring to the needs of each couple. We anticipate our pilot intervention will show promise for reducing male couples' HIV risk, which would then be further tested for efficacy through a larger RCT.