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

秘鲁利马顺性别男性夫妇基于网络的艾滋病毒预防工具包的可接受性、可行性和初步影响

• 批准号: 10633222
• 负责人: Jason W Mitchell
• 金额: $ 19.94万
• 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 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10633222
• 关键词: AIDS prevention; Adherence; Agreement; Algorithms; Area; Cellular Phone; Communication; Computers; Consent; Couples; Data Sources; Devices; Electronics; Elements; Eligibility Determination; Enrollment; Evaluation; Feedback; Goals; HIV; HIV Seronegativity; HIV Seropositivity; HIV/STD; Health; Home; Incidence; Individual; Internet; Intervention; Interview; Location; Measurement; Methods; Modeling; Online Systems; Outcome; Pattern; Peru; Pilot Projects; Prevention; Prevention strategy; Public Health; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research; Risk; Risk Reduction; STI prevention; Sex Behavior; Sexual Health; Stratification; Surveys; Testing; Time; Treatment Efficacy; United States Public Health Service; Update; Waiting Lists; Work; antiretroviral therapy; arm; behavior change; behavior test; cisgender; clinical care; commune; condoms; coping; cost; eHealth; evidence base; experience; follow-up; human centered design; improved; interest; male couples; member; men; men who have sex with men; novel; pre-exposure prophylaxis; preference; prevent; prevention service; preventive intervention; response; sexual minority men; sexual risk behavior; theories; transmission process; treatment as prevention; uptake; usability; web platform

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.

1 总结/摘要 2 3 秘鲁利马的性少数男性受到艾滋病毒的影响尤为严重，其中很大一部分 4 名男性在恋爱关系中感染艾滋病毒（即顺性别男性夫妇）。研究由成员进行。 5 调查小组发现，顺性别男性夫妇使用基于证据的艾滋病毒/性传播感染预防策略（例如， 6 ART、PrEP、常规 HIV/STI 检测、安全套使用）对于可靠预防感染和/或 7 鉴于目前的性危险行为，艾滋病毒和其他性传播感染的传播尚未出现。 利马或秘鲁其他地方提供 8 种基于艾滋病毒/性传播感染的预防干预措施。 9 拟议的三年期项目旨在帮助填补秘鲁艾滋病毒/性传播感染预防服务的这一关键空白。 10 开展了一个混合方法试点项目，以评估 PI 基于理论的电子医疗的可接受性， 利马 42 对顺性别男性夫妇进行了 11 起基于夫妻的 HIV/STI 预防工具包干预（14 名一致 12 位 HIV 阴性，16 位不一致，12 位一致 HIV 阳性） 90% 的夫妇表示对此的接受度很高。 13 干预，并且最喜欢协议构建活动 夫妇告诉我们他们想要更多信息。 14 关于艾滋病毒治疗作为预防（PrEP、ART、TasP/U=U）以及如何加强和管理自身和 15 家庭关系（文化背景）他们还希望可以在不同的网络上访问干预措施。 16 个联网设备的其他调查结果显示，只有 33%-50% 的夫妇包含基于证据的 HIV/STI。 他们同意的 17 项预防策略旨在帮助提高夫妇对循证方法的吸收和持续使用。 18 种预防策略，我们的解决方案是将电子算法集成到协议构建器活动中 19 为他们提供与他们的性行为相符的量身定制的建议 20 关系概况：通过提议的 R34，我们的下一步是应用其余阶段。 21 ADAPT-ITT 模型具有以人为本的设计元素，以适应我们基于夫妻的干预措施。 22 然后进行为期 6 个月的试点 RCT，并进行候补名单控制，以评估可行性、可接受性和初步结果 23 对 60 名顺性别男性夫妇进行调整后的干预措施（按其二人 HIV 血清状况分层）对 24 结果： a) 形成并遵守量身定制的风险降低计划和协议 b) 关系； 25 功能（例如沟通）；c) 使用基于证据的艾滋病毒预防策略；以及 d) 艾滋病毒/性传播感染的发生率； 26 随着时间的推移，我们提出的方法是严格的，具有科学前提，如混合方法和试点随机对照试验。 27 将使用候补名单控制来实现我们的具体目标。我们的项目也是及时、实用且关键的。 28 个利益相关者的支持，表明我们的提案对公共卫生具有重要意义。我们的研究结果将揭示这一点。 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 通过形成和坚持长期持续使用基于证据的艾滋病毒预防策略 31 定制协议和风险降低计划 我们的下一步将是应用这些发现（例如 R01）进行测试。 32 功效干预 我们的项目对 NOT-MH-20-019 和 NOT-MH-20-020 感兴趣。