Personalized prevention for couples

夫妻个性化预防

基本信息

批准号：
10664980
负责人：
Jason W Mitchell
金额：
$ 49.67万
依托单位：
FLORIDA INTERNATIONAL UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-01 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10664980
关键词：
AIDS prevention Adherence Affect Agreement Biological Markers Caring Characteristics Cities Communication Couples Data Data Sources Education Effectiveness Elements Evaluation Goals HIV HIV Infections HIV Seropositivity HIV disparities HIV risk HIV/STD Health Health behavior change Home Human immunodeficiency virus test Individual Intervention Interview Legitimacy Length Mediating Mental Health Method Acceptability Methods Modeling Outcome Pathway interactions Patient Self-Report Prevention Prevention strategy Process Public Health Randomized Randomized, Controlled Trials Reporting Research Risk Risk Reduction Role STI prevention Sampling Science Sex Behavior Shapes Social support Testing Time Treatment Efficacy Update Viral Work arm binge drinking cisgender commune coping digital eHealth effectiveness evaluation efficacy evaluation future implementation health information technology human centered design hybrid type 1 trial improved indicated prevention individualized prevention innovation intimate partner violence male male couples men who have sex with men multiple data sources novel pre-exposure prophylaxis prevention service preventive intervention programs response sex substance use theories time use transmission process uptake usability

项目摘要

1 SUMMARY / ABSTRACT 2 3 Between one to two-thirds of new HIV infections among MSM are attributable to sex with main partners (i.e., 4 male couples).1,2 48% of HIV-positive MSM in 5 US cities who were HIV tested in CDC's NHBS project were 5 unaware of their status,3 suggesting the potential for high levels of unknown sero-discordance among male 6 couples. Research has also illustrated the role that relationship dynamics (e.g., HIV-specific social support, 7 constructive communication, sexual agreements) have in shaping male couples' risk for HIV4-41; this has also 8 been shown longitudinally, strongly suggesting that promoting positive relationship dynamics is a significant 9 intervention point for reducing HIV transmission among male couples.42-44 There is also evidence at-risk male 10 couples can work together towards shared HIV prevention and care-related goals, including PrEP and U=U/TasP 11 that rely on adherence and resultant viral suppression, leading to increased health and reduced likelihood of 12 onward HIV transmission.45-55 Innovative and tailored solutions are needed to meet the HIV prevention and care 13 needs of at-risk male couples. Our solution is to leverage our strong findings from the preliminary work we 14 conducted in the US (R34 pilot RCT & mixed method acceptability project)59-62 to propose a highly novel, 5-year 15 project to revise and update an existing, eHealth couples-based HIV/STI prevention toolkit intervention that 16 showed promise for reducing couples' HIV risk. The intervention is theoretically grounded in Couples 17 Interdependence Theory for health behavior change.63,64 We will first apply the remaining stages of the ADAPT- 18 ITT model65 with elements of human-centered design66-69 to incorporate at-risk, sero-concordant negative and 19 sero-discordant male couples' prevention and relationship needs while also including the latest science in 20 HIV/STI prevention. We will then conduct a 16-month RCT with 300 at-risk male couples using a delayed, 21 educational control condition of 8 months. Our Specific Aims are to: 1) examine efficacy of the intervention on 22 couples' a) formation and adherence to a risk-reduction plan and agreement, b) relationship functioning, c) self- 23 reported and biomarker confirmed indicators of risk (sexual behavior and STI), and engagement in HIV 24 prevention (PrEP adherence) and care (ART adherence); 2) evaluate use of the intervention over time by using 25 three different data sources; 3) explore moderating and mediating effects on couples' outcomes a-c. Our proposal 26 has high Public Health significance given the HIV disparities and importance of attending to couples' unique 27 relationship and prevention needs. Our innovative, accessible, and tailored intervention will fill a gap in current 28 prevention services by offering couples a personalized program. We believe results from the fully powered RCT 29 will show efficacy toward improving sustained HIV prevention outcomes among at-risk male couples in the US. 30 The scientific premise and rigor will further allow us to understand the processes that couples work together 31 to manage HIV/STIs in their relationships. Our next steps may include conducting a Type 1 Hybrid Trial to assess 32 for effectiveness and explore best practices for future implementation.70

1 总结/摘要 2 3 MSM 中三分之一到三分之二的新艾滋病毒感染可归因于与主要伴侣的性行为（即， 4 对男性夫妇）。1,2 在 CDC NHBS 项目中接受 HIV 检测的美国 5 个城市中，48% 的 HIV 阳性 MSM 是 5 不知道自己的状况，3 表明男性之间可能存在高水平的未知血清不一致 6对情侣。研究还说明了关系动态（例如针对艾滋病毒的社会支持、 7 建设性沟通、性协议）对男性夫妇感染 HIV4-41 的风险有影响；这也有 8 纵向显示，强烈表明促进积极的关系动态是一个重要的减少男性夫妇之间艾滋病毒传播的 9 个干预点。42-44 也有证据表明男性处于高危人群 10 对夫妇可以共同努力实现共同的艾滋病毒预防和护理相关目标，包括 PrEP 和 U=U/TasP 11 依赖于坚持和由此产生的病毒抑制，从而提高健康水平并降低感染的可能性 12 今后的艾滋病毒传播。45-55 需要创新和量身定制的解决方案来满足艾滋病毒预防和护理的需要高危男性夫妇的 13 种需求。我们的解决方案是利用我们从前期工作中得出的强有力的发现 14 在美国进行（R34 试点 RCT 和混合方法可接受性项目）59-62 提出了一项高度新颖的、为期 5 年的研究 15 项目旨在修订和更新现有的、基于电子健康夫妇的艾滋病毒/性传播感染预防工具包干预措施， 16显示出降低夫妇感染艾滋病毒风险的希望。干预措施在理论上以夫妻为基础 17 健康行为改变的相互依存理论。63,64 我们将首先应用 ADAPT- 的其余阶段 18 ITT 模型65 具有以人为本的设计元素66-69，将有风险的、血清一致的阴性和 19 名血清不一致的男性夫妇的预防和关系需求，同时还包括最新的科学 20 艾滋病毒/性传播感染的预防。然后，我们将对 300 名高危男性夫妇进行为期 16 个月的随机对照试验，使用延迟、 21.教育控制状况8个月。我们的具体目标是：1）检查干预措施的有效性 22 对夫妇 a) 形成并遵守降低风险的计划和协议，b) 关系正常运转，c) 自我保护 23 项已报告并经生物标志物确认的风险指标（性行为和性传播感染）以及艾滋病毒参与度 24 预防（PrEP 依从性）和护理（ART 依从性）； 2) 评估随着时间的推移干预措施的使用 25 三种不同的数据源； 3）探索对夫妻结果a-c的调节和中介作用。我们的建议考虑到艾滋病毒差异以及关注夫妻独特情况的重要性，26 具有很高的公共卫生意义 27 关系和预防需求。我们创新、方便且量身定制的干预措施将填补当前的空白 28 项预防服务，为夫妻提供个性化计划。我们相信全动力 RCT 的结果 29 将显示对改善美国高危男性夫妇的持续艾滋病毒预防结果的功效。 30 科学前提和严谨性将进一步让我们了解夫妻共同努力的过程 31 管理人际关系中的艾滋病毒/性传播感染。我们接下来的步骤可能包括进行 1 型混合试验来评估 32 提高有效性并探索未来实施的最佳实践。70