Test-and-treat for Influenza in Homeless Shelters

NCT04141917 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY00007800
• Study Type: interventional
• Target: 1,618
• Locations: 1 country
• Sites: 9

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.

Conditions

Influenza; Respiratory Viral Infection

Keywords

Tamiflu; Oseltamivir; Baloxavir; Influenza; Flu; Rapid Test; Xofluza

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period

  The intervention period is when test and treatment on-site was available and the control period is when just standard surveillance was available at a shelter.

  Year 1 of the intervention (4.5 months)

Secondary Outcomes (7)

• Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters

  Up to 24 months

• Feasibility of Implementation of Influenza Treatment in Shelters

  Up to 24 months

• Number of Participants That Drop Out of Study

  Up to 24 months

• Number of Participants That Show Non-compliance With Study Drug

  Up to 24 months

• Number of Laboratory-confirmed Influenza Cases That Report Fever

  Up to 24 months

Study Arms (2)

Standard influenza surveillance

NO INTERVENTION

Subjects exhibiting ≥ 2 ARI symptoms or new or worsening cough in the last 7 days at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab for RT-PCR testing.

Point-of-care molecular testing and treatment of influenza

ACTIVE COMPARATOR

Subjects exhibiting ≥ 2 ARI symptoms, or new or worsening cough, in the last 48 hrs at a participating shelter complete a survey collecting demographic and clinical data, and provide a mid-turbinate nasal swab to be tested on-site with a molecular assay (Abbott ID NOW™ Influenza A \& B (Chicago, IL)) and receive an antiviral if tested positive (XOFLUZA™ or Tamiflu®) .

Combination Product: Point-of-care molecular testing and treatment of influenza

Interventions

Point-of-care molecular testing and treatment of influenza COMBINATION_PRODUCT

Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged \<12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving.

Point-of-care molecular testing and treatment of influenza

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Genentech, Inc.: collaborator

Study Sites (9)

Mary's Place Burien

Burien, Washington, 98146, United States

Location

Compass Housing Alliance at First Presbyterian

Seattle, Washington, 98104, United States

Location

Downtown Emergency Service Center Shelter

Seattle, Washington, 98104, United States

Location

ROOTS Young Adult Shelter

Seattle, Washington, 98105, United States

Location

Compass Housing Alliance Blaine Center Men's Shelter

Seattle, Washington, 98109, United States

Location

Mary's Place North Seattle

Seattle, Washington, 98133, United States

Location

St Martin De Porres Shelter

Seattle, Washington, 98134, United States

Location

Compass Housing Alliance Jan & Peter's Place Women's Shelter

Seattle, Washington, 98144, United States

Location

Mary's Place White Center

Seattle, Washington, 98146, United States

Location

Related Publications (9)

• 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.

  PMID: 30184455 BACKGROUND

• 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.

  PMID: 31211675 BACKGROUND

• 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.

  PMID: 9103130 BACKGROUND

• 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.

  PMID: 24499605 BACKGROUND

• 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.

  PMID: 36276877 DERIVED

• 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.

  PMID: 35749582 DERIVED

• 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.

  PMID: 34863618 DERIVED

• 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.

  PMID: 33228787 DERIVED

• 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.

  PMID: 32931328 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

Decline in influenza activity following the advent of SARS-CoV-2 public health mitigation measures led to early termination of study for operational futility purposes. Low infection detection and study power after year 1 also limited our ability to conduct statistical analyses on several intended secondary outcomes.

Results Point of Contact

• Title: Dr. Helen Chu
• Organization: University of Washington

helenchu@uw.edu

206-685-8702

Study Officials

• Helen Y Chu, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine: Division of Allergy & Infectious Diseases

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 28, 2019
• Study Start: November 15, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: June 22, 2022
• Results First Posted: June 22, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)