Personalized prevention for couples

1摘要/摘要 2. 3男男性接触者中新感染艾滋病毒的1/3至2/3可归因于与主要伴侣的性行为(即， 1，2，48%的美国5个城市的HIV阳性男男性行为者在CDC的NHBS项目中接受了HIV检测， 5不知道自己的状态，3表明男性中可能存在高度未知的血清不一致 6对夫妇。研究还表明，关系动态(例如，针对艾滋病毒的社会支持， 7建设性的沟通、性协议)在塑造男性夫妇感染HIV4-41病毒的风险方面起到了作用；这也 8是纵向的，强烈地表明促进积极的关系动态是一个重要的 9减少艾滋病毒在男性夫妇中传播的干预点。42-44也有证据表明高危男性 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，导致增加健康和降低发病的可能性 12艾滋病毒的传播。45-55需要创新和量身定做的解决方案来满足艾滋病毒的预防和护理 13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得出的强有力的发现 14在美国进行(R34 RCT和混合方法可接受性试验项目)59-62，以提出一个非常新颖的5年期 15修订和更新现有的以电子健康夫妇为基础的艾滋病毒/性传播感染预防工具包干预项目 16人表示有希望降低夫妇感染艾滋病毒的风险。理论上，这种干预是以夫妻为基础的 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的剩余阶段- 18 ITT型号65，采用以人为中心的设计元素66-69，将高危、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研究 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个月的教育控制条件。我们的具体目标是：1)检查干预的效果 22夫妻a)形成并遵守降低风险的计划和协议，b)关系运作，c)自我 23个报告和生物标记物确认的风险指标(性行为和性传播感染)，以及参与艾滋病毒 24预防(遵守PrEP)和护理(ART遵守)；2)评估干预措施随时间的使用情况 25三个不同的数据来源；3)探索对夫妻结局a-c的调节和中介效应。我们的建议 26具有很高的公共卫生意义，考虑到艾滋病毒的差异和关注夫妇独特的 27关系和预防需要。我们创新的、可访问的、量身定制的干预措施将填补当前 28通过为夫妇提供个性化计划提供预防服务。我们相信全功率随机对照试验的结果 29将显示出改善美国高危男性夫妇持续艾滋病毒预防结果的有效性。 30科学的前提和严谨将使我们进一步了解夫妻共同工作的过程 31在他们的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类型1混合试验，以评估 32以求实效，并探索今后实施的最佳做法。

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