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，美国58%至78%的MSM在同性关系(例如，男性伴侣)的背景下从他们的主要伴侣那里感染艾滋病毒。对男性夫妇的研究检查了哪些因素，包括性行为协议，会影响他们感染艾滋病毒的风险。在美国，许多男性情侣都有性行为协议：两个伴侣之间就他们的关系内外可能发生的性行为和其他行为达成的明确协议。从本质上讲，夫妻的性行为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，迫切需要考虑到男性夫妇的关系背景的新的新办法，以显著改善艾滋病毒预防。为了帮助填补这一关键缺口，这项拟议的为期3年的研究旨在为美国艾滋病毒阴性的高危男性夫妇开发和试点理论派生的、基于网络的艾滋病毒预防工具包。通过完成模块的完成，互动艾滋病毒预防工具包将指导和帮助目前实行无保护肛交(UAI)的高危艾滋病毒阴性男性夫妇--男男性接触者感染艾滋病毒的主要性行为--形成明确的性行为协议，其中包括艾滋病毒和性传播感染的间隔检测和预防信息，同时独特地满足他们关系的需要。基于网络的预防工具包将由两个部分组成：一个互动网站，其中包含供夫妇在达成协议时完成的基于理论的模块，以及相应的智能手机应用程序(APP)，其中将包含协议的副本以及启用GPS的性健康资源的列表，例如他们可以在哪里检测艾滋病毒和性传播感染，以及获取免费的更安全的性行为用品和生物医学预防方法。预防工具包的开发将分3个阶段进行。在第一阶段，我们将在底特律和亚特兰大对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，他们实行UAI，目前有性行为协议(15个开放，15个封闭)，以获得对预防工具包模块中内容的反馈，这些内容来自我们之前对男性夫妇的性协议和关系动态进行的广泛的艾滋病毒预防研究。从第一阶段获得的反馈将被整合以改进模块的内容，并被软件公司用来设计第一版本的预防工具包。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试行这些单元的内容，并就互动练习的呼吁和禁欲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，在开始试行干预措施之前，将对预防工具包进行进一步改进。在第三阶段，将通过互联网对160对高危艾滋病毒阴性男性夫妇进行为期6个月的小型前瞻性随机对照试验，以确定接受干预的夫妇(即预防工具包)是否会形成并遵守他们的性行为协议，提高他们的艾滋病毒和性传播感染的检测率，以及与控制组的临时MSM伴侣相比，他们避免或减少UAI的发生。这项拟议的研究是创新的，因为适当地使用了技术来最大限度地扩大影响范围和影响，同时根据每对夫妇的需求进行独特的定制。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前景，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.