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

PrEPmate 211：开发移动应用程序以支持美国 MSM 安全有效地使用按需 PrEP

• 批准号: 10242038
• 负责人: Albert Ying-Hwa Liu
• 金额: $ 19.05万
• 依托单位: PUBLIC HEALTH FOUNDATION ENTERPRISES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10242038
• 关键词: AIDS prevention; Accounting; Adherence; Affect; Antiviral Agents; Behavioral; California; Cities; Clinic; Clinic Visits; Clinical; Clinical Trials; Color; Complex; Counseling; Data; Development; Dose; Effectiveness; Enrollment; Ensure; Event; Feedback; Focus Groups; France; Frequencies; Guidelines; HIV; HIV Infections; HIV Seropositivity; HIV diagnosis; Harm Reduction; Hour; Individual; International; Intervention; Interview; Modeling; Motivation; Municipalities; New York; Oral; Pamphlets; Patients; Pattern; Performance; Pharmaceutical Preparations; Population; Provider; Public Health; Randomized; Randomized Controlled Trials; Regimen; Reporting; Risk; San Francisco; Societies; Surveys; System; Tenofovir; Testing; Time; United States; Urine; World Health Organization; Youth; acceptability and feasibility; arm; base; diaries; dose information; efficacy trial; improved; innovation; interest; mHealth; men who have sex with men; mobile application; novel; pill; pre-exposure prophylaxis; prevent; programs; response; satisfaction; self testing; sex; sexual encounter; shared decision making; side effect; skills; standard of care; test strip; tool; uptake; usability; web app; young men who have sex with men

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.

项目总结/摘要 在美国，男男性行为者（MSM）是受艾滋病毒影响最严重的人群， 超过三分之二的艾滋病新诊断病例。暴露前预防（PrEP）已证明高水平的 然而，预防艾滋病毒的有效性，全国范围内的PrEP启动率很低， 高按需PrEP，或在性行为之前/之后使用口服PrEP，已被证明在以下方面非常有效： 临床试验和现实世界的实践，并已得到国际抗病毒协会-美国和 世界卫生组织。在美国，对每日服用避孕药不感兴趣的男男性行为者表示， 对按需PrEP感兴趣，一些诊所已经开始提供按需PrEP作为替代方案， 然而，对于坚持这种复杂的方案（2片2-24 在性交前24小时和48小时后服用1片）。支持选择按需使用的个人的工具 PrEP对于确保有效性和最大限度地减少按需给药的危害至关重要。在这个R34应用程序中，我们 建议开发和完善一个移动的应用程序，PrEPmate 211，以支持安全和有效地使用上- 在美国MSM中要求PrEP。基于情境信息、动机、行为技能模型， 应用程序将具有1）“PrEP 211基础知识”，提供有关如何按需PrEP的信息; 2）激励 每周签到信息，以提供支持; 3）性和服药日记，提醒性行为前/后 剂量和显示保护时间的显示器;以及4）关于是否继续- 在目标1中，我们将评估患者和提供者确定的障碍， 通过与20名MSM的焦点小组和与5-7名临床 提供者，并征求他们的反馈，以告知PrEPmate 211的发展。在目标2中，我们将进行2 在12-15名MSM中进行为期一个月的优化试点，采取按需PrEP，以完善功能，技术 在目标3中，我们将进行一项试点随机对照试验， 评估PrEPmate 211的可行性，可接受性和初步影响，以增加PrEP覆盖率 性行为。在这项试验中，我们将招募60名目前正在服用或有兴趣开始按需PrEP的MSM，他们将 以2：1的比例随机接受PrEPmate 211（N=40）或加强标准治疗（手册和咨询 按需PrEP，瓶计时器盖显示最后一次给药的时间，N=20）。可行性和可接受性 应用程序将通过应用程序使用模式和系统可用性量表进行评估。初步 将通过评估PrEP通过性别/剂量评估的性行为比例来评估影响 数据输入PrEPmate 211或网络应用程序;我们还将试点使用新型尿液替诺福韦自我测试条 确认上周的PrEP剂量项目完成后，我们将开发一个高度创新的 工具，以支持MSM使用按需PrEP准备在一个更大的疗效试验测试。