Acceptability, feasibility, and preliminary impact of a web-based, HIV prevention toolkit with cisgender male couples in Lima, Peru

1摘要/摘要 2. 3在秘鲁利马，性少数族裔男子感染艾滋病毒的比例不成比例，其中相当大一部分人 4名男子在恋爱期间感染艾滋病毒(即，顺性别的男性夫妇)。委员会成员进行的研究 5调查小组发现，顺性别男性夫妇使用循证艾滋病毒/性传播感染预防策略(例如， 6抗逆转录病毒疗法、PrEP、常规HIV/STI检测、避孕套使用)对于可靠地预防感染和/或 7鉴于他们目前从事的性行为危险，艾滋病毒和其他性传播疾病的传播。到目前为止，还没有情侣- 在利马或秘鲁其他地方提供以8为基础的艾滋病毒/性传播感染预防干预措施。的首要目标是 9拟议的3年项目是为了帮助填补秘鲁艾滋病毒/性传播感染预防服务的这一严重缺口。首先，我们 10进行了一项混合方法试点项目，以评估PI基于理论基础的eHealth的可接受性， 在利马，对42对顺性男性夫妇进行了11对基于夫妇的HIV/STI预防工具包干预(14对符合 HIV阴性12例，不一致16例，一致阳性12例)。90%的夫妇表示他们对婚姻的接受度很高 13干预，最喜欢协议缔造者活动。情侣们告诉我们他们想要更多的信息 14关于艾滋病毒作为预防的治疗(PrEP、ART、TasP/U=U)以及如何加强和管理自己和 15个家庭关系(文化背景)。他们还希望干预可以在不同的网络上访问- 16台互联设备。其他研究结果显示，只有33%-50%的夫妇包括循证艾滋病毒/性传播感染 17项预防战略在他们的协议中。帮助夫妻理解和继续使用循证证据 18预防策略，我们的解决方案是将电子算法集成到协议建立者活动中，以 19为他们提供量身定做的建议，与他们的性行为和 20关系简档。方法：通过建议的R34，我们的下一步是应用 21采用以人为中心的设计元素的适应-ITT模式，以适应我们以夫妇为基础的干预。我们会 22然后进行为期6个月的试验性随机对照试验，并对照等待名单，评估可行性、可接受性和初步 23对60对顺性男性夫妇进行适应性干预的影响，按他们的二联体HIV血清状况分层 24成果：a)形成并遵守量身定做的减少风险计划和协议；b)关系 25运作(如通信)；c)使用循证艾滋病毒预防战略；d)艾滋病毒/性传播感染发病率 随着时间的推移，26岁。我们建议的方法是严格的，以科学为前提的混合方法和试验性随机对照试验 27将使用轮候名单控制来实现我们的具体目标。我们的项目也是及时和实用的 28利益相关者买入，表明我们的提案对公共卫生的高度意义。我们的发现将揭示 29调整后的工具包干预措施降低夫妇艾滋病毒/性传播感染风险的可行性、可接受性和初步影响 30通过形成和遵守循证艾滋病毒预防战略，随着时间的推移持续使用这些战略 31达成了一项量身定制的协议和降低风险的计划。我们的下一步将是将这些发现(例如R01)应用于测试 32疗效干预。我们的项目对NOT-MH-20-019和NOT-MH-20-020感兴趣。

1 SUMMARY / ABSTRACT 2 3 Sexual minority men in Lima, Peru are disproportionately impacted by HIV, and a substantial proportion of these 4 men acquire HIV while in a relationship (i.e., cisgender male couples). Studies conducted by members of the 5 investigative team found that cisgender male couples’ use of evidence-based HIV/STI prevention strategies (e.g., 6 ART, PrEP, routine HIV/STI testing, condom use) are sub-optimal to reliably prevent acquisition and/or 7 transmission of HIV and other STIs given their current engagement in sexual risk behaviors. To date, no couples- 8 based HIV/STI prevention interventions are available in Lima or elsewhere in Peru. The overarching goal of the 9 proposed 3-year project is to help fill this critical gap in Peru’s HIV/STI prevention services. To start, we 10 conducted a mixed method pilot project to assess the acceptability of the PI’s theoretically-grounded eHealth, 11 couples-based HIV/STI prevention toolkit intervention with 42 cisgender male couples in Lima (14 concordant 12 HIV-negative, 16 discordant, 12 concordant HIV-positive). 90% of couples reported high acceptability of the 13 intervention, and liked the agreement builder activity the most. Couples told us they wanted more information 14 about HIV treatment as prevention (PrEP, ART, TasP/U=U) and how to strengthen and manage their own and 15 familial relationships (cultural context). They also wanted the intervention to be accessible on different web- 16 connected devices. Additional findings revealed only 33%-50% of couples included evidence-based HIV/STI 17 prevention strategies in their agreement. To help improve couples’ uptake and continued use of evidence-based 18 prevention strategies, our solution is to integrate an electronic algorithm into the agreement builder activity to 19 provide them with tailored recommendations that align with their engagement in sexual behaviors and 20 relationship profile. Methods: Via the proposed R34, our next steps are to apply the remaining stages of the 21 ADAPT-ITT model with elements of human-centered design to adapt our couples-based intervention. We will 22 then conduct a 6-month pilot RCT with a waitlist control to assess the feasibility, acceptability, and preliminary 23 impact of the adapted intervention with 60 cisgender male couples, stratified by their dyad HIV serostatus, on 24 outcomes of: a) formation and adherence to a tailored risk-reduction plan and agreement; b) relationship 25 functioning (e.g., communication); c) use of evidence-based HIV prevention strategies; and d) HIV/STI incidence 26 over time. Our proposed approach is rigorous with scientific premise as mixed methods and a pilot RCT with 27 a waitlist control will be used to achieve our Specific Aims. Our project is also timely and practical with key 28 stakeholder buy-in, suggesting the high Public Health significance of our proposal. Our findings will reveal the 29 feasibility, acceptability and preliminary impact of the adapted toolkit intervention to reduce couples’ HIV/STI risk 30 via sustained use of evidence-based HIV prevention strategies over time through their formation and adherence 31 to a tailored agreement and risk-reduction plan. Our next step will be to apply these findings (e.g., R01) to test 32 the intervention for efficacy. Our project is of interest to NOT-MH-20-019 and NOT-MH-20-020.