PrEPmate 211: Developing a mobile app to support the safe and effective use of on-demand PrEP among MSM in the US

项目摘要/摘要 男男性行为者(MSM)是美国受艾滋病毒影响最大的人群，据统计 在所有新的艾滋病毒诊断病例中，有三分之二以上。暴露前预防(PrEP)显示出高水平的 然而，对于艾滋病毒预防的有效性，全国范围内的PrEP启动率一直很低，停用率为 很高。按需使用PrEP，或在性行为前/之后使用口服PrEP，已被证明对 临床试验和现实世界实践，并已得到国际抗病毒协会-美国和 世界卫生组织。美国男男性接触者对每天服用避孕药不感兴趣，他们表达了很高的水平 对按需PrEP感兴趣，几家诊所已开始提供按需PrEP作为替代 每日预习。然而，对于遵守这一复杂的方案(2粒2-24粒)，人们有很大的担忧 性行为前数小时，24小时和48小时后各1粒)。支持选择按需使用的个人的工具 准备工作是确保按需给药的有效性和将危害降至最低的关键。在此R34应用程序中，我们 建议开发和完善移动应用PrEPmate 211，以支持安全有效地使用ON- 美国男男性接触者对PrEP的需求。基于情境信息、动机、行为技能模型，这 应用程序将以1)《PrEP 211基础知识》为特色，提供有关如何按需使用PrEP的信息；2)激励 每周的签到信息以提供支持；3)性生活和服药日记，以及性行为前/性后的提醒 剂量和显示保护时间的显示器；以及4)关于是否继续- 点播PrEP或改用每日PrEP。在目标1中，我们将评估患者和提供者确定的障碍和 通过与20名MSM的焦点小组和5-7名临床医生的访谈，促进按需使用PrEP 并征求他们的反馈意见，以便为PrEPmate 211的开发提供信息。在目标2中，我们将进行2 在12-15个月的MSM中进行月优化试点，按需进行PrEP以完善功能、技术 性能，以及应用程序的用户满意度。在目标3中，我们将进行试点随机对照试验，以 评估PrEPmate 211扩大PrEP覆盖范围的可行性、可接受性和初步影响 性行为。在此试验中，我们将招募60名正在接受或有兴趣启动按需PrEP的MSM，他们将 随机2：1接受PrEPmate 211(N=40)或增强型护理标准(手册和咨询 按需PrEP，瓶盖计时器显示最后一次给药时间，N=20)。该计划的可行性和可接受性 APP将通过APP ParaData的使用模式和系统可用性尺度进行评估。初步 将通过评估通过性行为/剂量评估的PrEP覆盖的性行为的比例来评估影响 数据输入PrEPmate 211或网络应用程序；我们还将试点使用一种新的尿替诺福韦自我检测试纸 以确认过去一周的PrEP剂量。项目完成后，我们将开发出一种高度创新的 支持MSM使用按需PrEP的工具，准备在更大的疗效试验中进行测试。

Project Summary/Abstract Men who have sex with men (MSM) are the population most affected by HIV in the United States, accounting for over two-thirds of all new HIV diagnoses. Pre-exposure prophylaxis (PrEP) has demonstrated high levels of efficacy for HIV prevention, however, PrEP initiations have been low nationwide, and discontinuation rates are high. On-demand PrEP, or the use of oral PrEP before/after sex, has been shown to be highly effective in clinical trials and real-world practice and has been endorsed by the International Antiviral Society-USA and World Health Organization. MSM in the US not interested in taking a daily pill have expressed high levels interest in on-demand PrEP, and several clinics have begun offering on-demand PrEP as an alternative to daily PrEP. However, there are substantial concerns about adherence to this complex regimen (2 pills 2-24 hours before sex, 1 pill 24 and 48 hours later). Tools to support individuals who choose to use on-demand PrEP are critical to ensure effectiveness and minimize harm of on-demand dosing. In this R34 application, we propose to develop and refine a mobile app, PrEPmate 211, to support the safe and effective use of on- demand PrEP among US MSM. Grounded in the situated Information, Motivation, Behavioral Skills model, this app will feature 1) "PrEP 211 Basics" providing information on how to take on-demand PrEP; 2) motivational weekly check-in messages to provide support; 3) a sexual and pill-taking diary, with reminders for pre/post-sex doses and display showing time to protection; and 4) a shared decision-making tool on whether to continue on- demand PrEP or switch to daily PrEP. In aim 1, we will assess patient and provider-identified barriers and facilitators of on-demand PrEP use through focus groups with 20 MSM and interviews with 5-7 clinical providers, and elicit their feedback to inform the development of PrEPmate 211. In aim 2, we will conduct a 2 month optimization pilot among 12-15 MSM taking on-demand PrEP to refine the functionality, technical performance, and user satisfaction of the app. In aim 3, we will conduct a pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary impact of PrEPmate 211 to increase PrEP coverage of sex acts. In this trial, we will enroll 60 MSM currently taking or interested in starting on-demand PrEP who will be randomized 2:1 to receive PrEPmate 211 (N=40) or enhanced standard of care (brochure and counseling on on-demand PrEP with bottle timer cap showing time of last dose, N=20). Feasibility and acceptability of the app will be assessed through app paradata of usage patterns and the System Usability Scale. Preliminary impact will be assessed by evaluating the proportion of sex acts covered by PrEP assessed via sex/dosing data entered into PrEPmate 211 or a web app; we will also pilot the use of a novel urine tenofovir self-test strip to confirm PrEP dosing in the past week. Upon project completion, we will have developed a highly innovative tool to support MSM using on-demand PrEP ready for testing in a larger efficacy trial.