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摘要 /摘要 2 MSM中新艾滋病毒感染的三分之一至三分之二归因于与主要伴侣的性行为（即， 4位男性夫妇）.1,2 48％的HIV阳性MSM在5个在CDC的NHBS项目中测试HIV的美国城市是 5没有意识到自己的状态，3表明雄性有可能获得高水平的无知血清差异 6对夫妇。研究还说明了关系动态的作用（例如，特定于HIV的社会支持， 7建设性沟通，性协议）具有塑造男性夫妇对HIV4-41的风险的影响；这也有 8纵向显示，强烈表明促进正相关动态是重要的 9减少男性夫妇艾滋病毒传播的干预点。42-44也有证据表明男性 10对夫妇可以共同努力为共享的HIV预防和与护理有关的目标，包括PREP和U = U/TASP 11依赖于依从性和导致的病毒抑制，从而增加健康状况和降低的可能性 12向前艾滋病毒传播。45-55需要创新和量身定制的解决方案来满足艾滋病毒的预防和护理 13个高危男性夫妇的需求。我们的解决方案是利用我们从初步工作中的有力发现 14在美国进行（R34 Pilot RCT和混合方法可接受性项目）59-62提出了一个高度新颖的5年 15修改和更新现有的基于eHealth夫妇的艾滋病毒/STI预防工具包干预措施的项目 16显示了降低夫妇的艾滋病毒风险的希望。理论上的干预是在夫妻中接地的 17健康行为的相互依赖理论变化。63,64我们将首先应用适应性的剩余阶段 18 ITT Model65具有以人为中心设计的元素66-69，以融合在风险的，血清概念的负面和 19血清男性夫妻的预防和关系需求，同时还包括最新的科学 20 HIV/STI预防。然后，我们将使用延迟的，延迟 21教育控制条件为8个月。我们的具体目的是：1）检查干预的功效 22夫妇的a）形成和遵守风险降低计划和协议，b）关系功能，c）自我 23报告和生物标志物确认了风险（性行为和性传播感染）的指标，并参与艾滋病毒 24预防（准备依从性）和护理（艺术依从性）； 2）通过使用随着时间的推移评估干预措施的使用 25三个不同的数据源； 3）探索对夫妻结果A-C的调节和中介作用。我们的建议鉴于艾滋病毒差异和参与夫妻的独特性的重要性和重要性，26具有很高的公共卫生意义 27关系和预防需求。我们的创新，可访问和量身定制的干预措施将填补当前的空白 28预防服务通过为夫妻提供个性化计划。我们相信完全动力的RCT的结果 29将显示出在美国高危男性夫妇中改善持续的HIV预防结果的功效。 30科学前提和严格将进一步使我们了解夫妻共同努力的过程 31在他们的关系中管理艾滋病毒/性传播疾病。我们的下一步可能包括进行1型混合试验以评估 32有关有效性并探索未来实施的最佳实践。70