Clinical trial NCT04141917: Test-and-treat for Influenza in Homeless Shelters
Official title: Stepped-wedge Design Study of Point-of-care Molecular Testing for Influenza and Treatment With Baloxavir for Prevention of Secondary Transmission of Influenza in Homeless Shelters in Seattle, WA
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Influenza
Respiratory Viral Infection
Keywords: Tamiflu
Oseltamivir
Baloxavir
Influenza
Flu
Rapid Test
Xofluza
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2019-10-28
Enrollment: 1618
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is a stepped-wedge cluster-randomized trial of on-site rapid testing and treatment for influenza in homeless shelters within the Seattle area to determine whether this strategy reduced the incidence of influenza in the shelter environment.

Detailed description: The study will be conducted over the course of two flu seasons, and all shelters will start with routine surveillance of influenza using mid-turbinate nasal swabs for sample collection and RT-PCR testing. Shelters will be randomized to implement a test-and-treat strategy at different months throughout flu season, treating individuals who present ARI symptoms or new or worsening cough within 2 days (48 hours). Shelters will continue routine surveillance until all offer the test-and-treat strategy. Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment. Individuals with 3-7 days of symptoms, or who choose not to participate in the intervention strategy, will still be eligible for participation in the routine surveillance.

Our primary hypothesis is that implementation of a point-of-care diagnostic and antiviral treatment intervention among sheltered individuals experiencing homelessness will reduce the incidence of influenza within this population over the course of a flu season. A process evaluation will also be conducted to explore the feasibility of point-of-care testing implementation in this population.

Eligibility criteria: Inclusion Criteria:

* Resident for 1 or more days at a participating shelter
* ≥2 ARI symptoms or acute cough alone
* Willing to take study medication
* Willing to comply with all study procedures, including weekly surveillance and repeat nasal swab at day 2/3 and day 5/6/7 post-treatment
* Able to provide written, informed consent and/or assent

Exclusion Criteria:

* Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration
* Inability to consent and/or comply with study protocol
* Individuals who have received oseltamivir or baloxavir within past 7 days for treatment of influenza
* Individuals with known hypersensitivity to baloxavir marboxil or oseltamivir
* Individuals with chronic kidney disease

Primary outcomes:
measure: Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period
timeFrame: Year 1 of the intervention (4.5 months)
Secondary outcomes:
measure: Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters
timeFrame: Up to 24 months
measure: Feasibility of Implementation of Influenza Treatment in Shelters
timeFrame: Up to 24 months
measure: Number of Participants That Drop Out of Study
timeFrame: Up to 24 months
measure: Number of Participants That Show Non-compliance With Study Drug
timeFrame: Up to 24 months
measure: Number of Laboratory-confirmed Influenza Cases That Report Fever
timeFrame: Up to 24 months
measure: Influenza Viral RNA Levels
timeFrame: Up to 24 months
measure: Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Burien
country: United States
facility: Mary's Place Burien
state: Washington
city: Seattle
country: United States
facility: Compass Housing Alliance at First Presbyterian
state: Washington
city: Seattle
country: United States
facility: Downtown Emergency Service Center Shelter
state: Washington
city: Seattle
country: United States
facility: ROOTS Young Adult Shelter
state: Washington
city: Seattle
country: United States
facility: Compass Housing Alliance Blaine Center Men's Shelter
state: Washington
city: Seattle
country: United States
facility: Mary's Place North Seattle
state: Washington
city: Seattle
country: United States
facility: St Martin De Porres Shelter
state: Washington
city: Seattle
country: United States
facility: Compass Housing Alliance Jan & Peter's Place Women's Shelter
state: Washington
city: Seattle
country: United States
facility: Mary's Place White Center
state: Washington
Study officials:
affiliation: University of Washington
name: Helen Y Chu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197.
citation: Boonyaratanakornkit J, Ekici S, Magaret A, Gustafson K, Scott E, Haglund M, Kuypers J, Pergamit R, Lynch J, Chu HY. Respiratory Syncytial Virus Infection in Homeless Populations, Washington, USA. Emerg Infect Dis. 2019 Jul;25(7):1408-1411. doi: 10.3201/eid2507.181261.
citation: Hwang SW, Orav EJ, O'Connell JJ, Lebow JM, Brennan TA. Causes of death in homeless adults in Boston. Ann Intern Med. 1997 Apr 15;126(8):625-8. doi: 10.7326/0003-4819-126-8-199704150-00007.
citation: Thiberville SD, Salez N, Benkouiten S, Badiaga S, Charrel R, Brouqui P. Respiratory viruses within homeless shelters in Marseille, France. BMC Res Notes. 2014 Feb 5;7:81. doi: 10.1186/1756-0500-7-81.
citation: Cox SN, Rogers JH, Thuo NB, Meehan A, Link AC, Lo NK, Manns BJ, Chow EJ, Al Achkar M, Hughes JP, Rolfes MA, Mosites E, Chu HY. Trends and factors associated with change in COVID-19 vaccination intent among residents and staff in six Seattle homeless shelters, March 2020 to August 2021. Vaccine X. 2022 Dec;12:100232. doi: 10.1016/j.jvacx.2022.100232. Epub 2022 Oct 19.
citation: Chow EJ, Casto AM, Roychoudhury P, Han PD, Xie H, Pfau B, Nguyen TV, Sereewit J, Rogers JH, Cox SN, Wolf CR, Rolfes MA, Mosites E, Uyeki TM, Greninger AL, Hughes JP, Shim MM, Sugg N, Duchin JS, Starita LM, Englund JA, Chu HY. The Clinical and Genomic Epidemiology of Rhinovirus in Homeless Shelters-King County, Washington. J Infect Dis. 2022 Oct 7;226(Suppl 3):S304-S314. doi: 10.1093/infdis/jiac239.
citation: Rogers JH, Cox SN, Hughes JP, Link AC, Chow EJ, Fosse I, Lukoff M, Shim MM, Uyeki TM, Ogokeh C, Jackson ML, Boeckh M, Englund JA, Mosites E, Rolfes MA, Chu HY. Trends in COVID-19 vaccination intent and factors associated with deliberation and reluctance among adult homeless shelter residents and staff, 1 November 2020 to 28 February 2021 - King County, Washington. Vaccine. 2022 Jan 3;40(1):122-132. doi: 10.1016/j.vaccine.2021.11.026. Epub 2021 Nov 15.
citation: Newman KL, Rogers JH, McCulloch D, Wilcox N, Englund JA, Boeckh M, Uyeki TM, Jackson ML, Starita L, Hughes JP, Chu HY; Seattle Flu Study Investigators. 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. Trials. 2020 Nov 23;21(1):956. doi: 10.1186/s13063-020-04871-5.
citation: Rogers JH, Link AC, McCulloch D, Brandstetter E, Newman KL, Jackson ML, Hughes JP, Englund JA, Boeckh M, Sugg N, Ilcisin M, Sibley TR, Fay K, Lee J, Han P, Truong M, Richardson M, Nickerson DA, Starita LM, Bedford T, Chu HY; Seattle Flu Study Investigators. Characteristics of COVID-19 in Homeless Shelters : A Community-Based Surveillance Study. Ann Intern Med. 2021 Jan;174(1):42-49. doi: 10.7326/M20-3799. Epub 2020 Sep 15.