Division of Allergy and Infectious Diseases, University of Washington, UW Medicine at South Lake Union, Chu Lab Room E630, 750 Republican St., Seattle, WA, 98109, USA.
Seattle Children's Research Institute, Seattle, WA, USA.
Trials. 2020 Nov 23;21(1):956. doi: 10.1186/s13063-020-04871-5.
Influenza is an important public health problem, but data on the impact of influenza among homeless shelter residents are limited. The primary aim of this study is to evaluate whether on-site testing and antiviral treatment of influenza in residents of homeless shelters reduces influenza spread in these settings.
This study is a stepped-wedge cluster-randomized trial of on-site testing and antiviral treatment for influenza in nine homeless shelter sites within the Seattle metropolitan area. Participants with acute respiratory illness (ARI), defined as two or more respiratory symptoms or new or worsening cough with onset in the prior 7 days, are eligible to enroll. Approximately 3200 individuals are estimated to participate from October to May across two influenza seasons. All sites will start enrollment in the control arm at the beginning of each season, with routine surveillance for ARI. Sites will be randomized at different timepoints to enter the intervention arm, with implementation of a test-and-treat strategy for individuals with two or fewer days of symptoms. Eligible individuals will be tested on-site with a point-of-care influenza test. If the influenza test is positive and symptom onset is within 48 h, participants will be administered antiviral treatment with baloxavir or oseltamivir depending upon age and comorbidities. Participants will complete a questionnaire on demographics and symptom duration and severity. The primary endpoint is the incidence of influenza in the intervention period compared to the control period, after adjusting for time trends.
ClinicalTrials.gov NCT04141917 . Registered 28 October 2019. Trial sponsor: University of Washington.
流感是一个重要的公共卫生问题，但有关无家可归者收容所居民中流感影响的数据有限。本研究的主要目的是评估在无家可归者收容所居民中进行现场检测和流感抗病毒治疗是否能降低这些环境中的流感传播。
这是西雅图大都市区内 9 个无家可归者收容所进行现场流感检测和抗病毒治疗的阶梯式楔形集群随机试验。有急性呼吸道疾病（ARI）的参与者符合条件，定义为在过去 7 天内出现两种或更多呼吸道症状或新出现或恶化的咳嗽。预计在两个流感季节的 10 月至 5 月期间，将有大约 3200 人参与。所有地点将在每个季节开始时进入对照组，对 ARI 进行常规监测。将在不同时间点随机分配到干预组，对出现 2 天或更短症状的个体实施检测和治疗策略。符合条件的个人将在现场进行即时护理流感检测。如果流感检测呈阳性且症状出现时间在 48 小时内，则根据年龄和合并症为参与者开出处方抗病毒药物 baloxavir 或奥司他韦。参与者将完成一份关于人口统计学和症状持续时间和严重程度的问卷。主要终点是调整时间趋势后，干预期与对照组相比流感的发病率。
ClinicalTrials.gov NCT04141917。注册于 2019 年 10 月 28 日。试验赞助商：华盛顿大学。
