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. 2020 Nov 23;21(1):956.
doi: 10.1186/s13063-020-04871-5.

Point-of-care molecular testing and antiviral treatment of influenza in residents of homeless shelters in Seattle, WA: study protocol for a stepped-wedge cluster-randomized controlled trial

Kira L Newman  1 , Julia H Rogers  1 , Denise McCulloch  1 , Naomi Wilcox  1 , Janet A Englund  1   2 , Michael Boeckh  1   3 , Timothy M Uyeki  4 , Michael L Jackson  5 , Lea Starita  1 , James P Hughes  1 , Helen Y Chu  6 ; Seattle Flu Study Investigators
Affiliations

Point-of-care molecular testing and antiviral treatment of influenza in residents of homeless shelters in Seattle, WA: study protocol for a stepped-wedge cluster-randomized controlled trial

Kira L Newman et al. Trials. .

Abstract

Introduction: 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.

Methods and analysis: 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.

Trial registration: ClinicalTrials.gov NCT04141917 . Registered 28 October 2019. Trial sponsor: University of Washington.

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Conflict of interest statement

JAE: Consulting fees from Sanofi Pasteur and Meissa Vaccines; research support from AstraZeneca, GlaxoSmithKline, Novavax, and Merck. MB: Consulting fees and research support from Gilead Sciences, Janssen, Ansun Biopharma, GlaxoSmithKline, Vir Biotechnology; consulting fees from Pulmocyte, Adma Biologics, Moderna, Evrys Bio; research support from Alveo. MLJ: research funding from Sanofi Pasteur. HYC: Consulting fees from Merck and Glaxo Smith Kline, and research support from Sanofi Pasteur, Ellume, Genentech, and Cepheid. All other authors report no competing interests.

Figures

Fig. 1
Fig. 1
Stepped-wedge design for trial with theoretical influenza (flu) seasons
Fig. 2
Fig. 2
Trial schema
Fig. 3
Fig. 3
Asymptomatic enrollment schema for study participation November 2019–March 2020. Asymptomatic study participation was modified from a monthly activity to every day there was a research assistant on-site conducting study recruitment and enrollments at a shelter
See this image and copyright information in PMC

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