Personalized prevention for couples

夫妻个性化预防

• 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
• 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

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概要/摘要 2 3在男男性行为者中，三分之一至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的NHBS项目中接受HIV检测的5个美国城市中，48%的HIV阳性MSM是 5例不知道自己的状况，3例提示男性中存在高水平未知血清不一致的可能性 六对夫妇。研究还说明了关系动态（例如，针对艾滋病毒的社会支助， 7建设性的沟通，性协议）在塑造男性夫妇的艾滋病毒风险4 -41;这也 8纵向显示，强烈表明促进积极的关系动态是一个重要的 减少男性配偶之间艾滋病毒传播的9个干预点42 -44 10对夫妇可以共同努力实现艾滋病毒预防和护理相关的目标，包括PrEP和U=U/TasP 11依赖于坚持和由此产生的病毒抑制，导致增加健康和减少的可能性， 45 -55需要有创新的、量身定制的解决方案，以满足艾滋病毒预防和护理的需求。 有风险的男性伴侣的13种需求。我们的解决方案是利用我们从初步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，以提出一种高度新颖的5年期 15个项目，修订和更新现有的基于电子保健夫妇的艾滋病毒/性传播感染预防工具包干预措施， 16项研究显示，有希望降低夫妇感染艾滋病毒的风险。这种干预在理论上是以夫妇为基础的。 17健康行为改变的相互依赖理论。63，64我们将首先应用适应性调整的其余阶段， 18 ITT模型65，具有以人为中心的设计元素66 -69，以纳入有风险、血清一致性阴性和 19对血清不一致的男性夫妇的预防和关系需求，同时也包括最新的科学， 20预防艾滋病毒/性传播感染。然后，我们将对300对高危男性夫妇进行为期16个月的随机对照试验， 21例8个月的教育对照情况。我们的具体目标是：1）检查干预的有效性， 22对夫妇的a）形成和遵守风险降低计划和协议，B）关系运作，c）自我 23个报告的和生物标志物证实的风险指标（性行为和性传播感染），以及艾滋病毒感染情况 24预防（PrEP依从性）和护理（ART依从性）; 2）通过使用 25三种不同的数据来源; 3）探索对夫妇结果的调节和中介作用a-c。我们的建议 26具有很高的公共卫生意义，因为艾滋病毒的差异和照顾夫妇独特的重要性， 27、预防和控制的需要。我们创新的、可获得的和量身定制的干预措施将填补当前 28预防服务，为夫妇提供个性化的计划。我们认为，全功率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有效性。 30科学的前提和严谨性将进一步让我们了解夫妻共同工作的过程 31人在其关系中管理艾滋病毒/性传播感染。我们的下一步可能包括进行1型混合试验， 32以提高效率，并探讨今后实施的最佳做法。