Parrying the Pitfalls of PrEP: Preventing Premature PrEP Discontinuation and STIs among Young Black MSM

避开 PrEP 的陷阱：防止年轻黑人 MSM 过早停止 PrEP 和性传播感染

• 批准号: 10399433
• 负责人: Colleen F Kelley
• 金额: $ 75万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10399433
• 关键词: AIDS prevention; Characteristics; Clinical; Consultations; Counseling; Data; Diagnosis; Dose; Doxycycline; Drug usage; Early Intervention; Elements; Enrollment; Epidemic; Evaluation; HIV; HIV Infections; HIV Seronegativity; HIV diagnosis; Hour; Incidence; Infection; Intervention; Lead; Measures; Modeling; National Institute of Drug Abuse; Oral; Outcome; Pattern; Population; Prevention approach; Process Measure; Prophylactic treatment; Reporting; Risk; Role; Services; Sexually Transmitted Diseases; Surveys; System; United States; Visit; Work; aged; arm; base; black men who have sex with men; cohort; condoms; diaries; experience; falls; high risk; innovation; insight; interest; men; men who have sex with men; mobile application; motivational enhancement therapy; novel; peer; pill; premature; prevent; preventive intervention; primary outcome; prospective; randomized trial; response; screening; sex; side effect; success; trial design; uptake

Abstract Young (aged 18-29) Black men who have sex with men (YBMSM) in Atlanta experience high rates of HIV acquisition (8.9%/year) and STI infection (30%/year). Over the past 5 years, we have followed a cohort of 300 YBMSM in Atlanta and have offered PrEP as part of a comprehensive package of prevention interventions. We have had substantial uptake of PrEP – over 40% of YBMSM initiated PrEP – but we have also observed high rates of PrEP discontinuation (39% of all PrEP starts) and ongoing high rates of new STI diagnoses. Even with 44% PrEP uptake in the cohort, HIV incidence remained high at 6.2%/year. This represents a 30% reduction in HIV incidence compared to our pre-PrEP comparison cohort, but is still unacceptably high. Therefore, we proposed to continue our cohort approach but to add three new interventions: (1) an innovative “early warning” system to identify YBMSM on PrEP who are at risk for discontinuing PrEP, and providing a motivational interviewing-based peer intervention; (2) offering on-demand PrEP to men who decline daily PrEP or who plan to stop daily PrEP because they are unwilling to take a daily pill or perceive their risks to be infrequent; and (3) offering STI PEP with doxycycline for all men, regardless of PrEP use, to avert new STIs. This is an implementation-focused, single arm cohort approach, using a target trial design to emulate a randomized trial and evaluation of process measures. Primary outcomes are rates of PrEP discontinuation and rates of new STI diagnoses.

摘要 亚特兰大的年轻（18-29岁）黑人男男性行为者（YBMSM）感染艾滋病毒的比率很高 感染率（8.9%/年）和性传播感染率（30%/年）。在过去的5年里，我们跟踪了300名 YBMSM在亚特兰大，并提供了PrEP作为一个全面的一揽子预防干预措施的一部分。 我们已经大量吸收了PrEP -超过40%的YBMSM启动了PrEP -但我们也观察到 PrEP中断率高（所有PrEP开始的39%）和新的STI诊断率持续高。 即使队列中PrEP摄取率为44%，艾滋病毒发病率仍高达6.2%/年。这代表了30% 与我们的PrEP前比较队列相比，HIV发病率有所降低，但仍然高得不可接受。 因此，我们建议继续我们的队列方法，但增加三个新的干预措施：（1）创新的 “早期预警”系统，以确定YBMSM在PrEP谁是在风险中断PrEP，并提供一个 基于动机访谈的同伴干预;（2）向拒绝每日PrEP的男性提供按需PrEP 或计划停止每日PrEP的人，因为他们不愿意每天服用药丸或认为他们的风险是 罕见;（3）为所有男性提供带有强力霉素的STI PEP，无论是否使用PrEP，以避免新的STI。 这是一种以实施为重点的单臂队列方法，使用靶向试验设计来模拟 随机试验和过程措施评价。主要结局是PrEP中止率 和新的性传播感染诊断率。