Test-and-treat for Influenza in Homeless Shelters

May 23, 2022 updated by: Helen Chu, University of Washington

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1618

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Burien, Washington, United States, 98146
        • Mary's Place Burien
      • Seattle, Washington, United States, 98104
        • Compass Housing Alliance at First Presbyterian
      • Seattle, Washington, United States, 98104
        • Downtown Emergency Service Center Shelter
      • Seattle, Washington, United States, 98105
        • ROOTS Young Adult Shelter
      • Seattle, Washington, United States, 98109
        • Compass Housing Alliance Blaine Center Men's Shelter
      • Seattle, Washington, United States, 98133
        • Mary's Place North Seattle
      • Seattle, Washington, United States, 98134
        • St Martin De Porres Shelter
      • Seattle, Washington, United States, 98144
        • Compass Housing Alliance Jan & Peter's Place Women's Shelter
      • Seattle, Washington, United States, 98146
        • Mary's Place White Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard influenza surveillance
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.
Active Comparator: Point-of-care molecular testing and treatment of influenza
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period
Time Frame: Year 1 of the intervention (4.5 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters
Time Frame: Up to 24 months
Number of participants/participant encounters with les than 48 hours between symptom onset until diagnosis with RT-PCR.
Up to 24 months
Feasibility of Implementation of Influenza Treatment in Shelters
Time Frame: Up to 24 months
Number of influenza-positive participants identified through on-site molecular testing in the intervention period that were treated with an antiviral
Up to 24 months
Number of Participants That Drop Out of Study
Time Frame: Up to 24 months
Measured as becoming lost to follow-up (did not complete both follow-up study visits on day 2/3 and day 5/6/7) after testing positive for influenza at baseline enrollment with an on-site molecular test and receiving an antiviral
Up to 24 months
Number of Participants That Show Non-compliance With Study Drug
Time Frame: Up to 24 months
Only applicable to those that receive oseltamivir rather than baloxavir which is a single-dose antiviral. Measured based on self-report during follow-up visits with study research assistants. Non-compliance is measured as the participant self-reporting fewer doses taken than to be expected at time of of follow-up (e.g. a participant that took there first dose of oseltamivir in the AM on March 8 would be expected to have taken 6 doses if their follow-up visit was in the PM on March 10).
Up to 24 months
Number of Laboratory-confirmed Influenza Cases That Report Fever
Time Frame: Up to 24 months
Based on self-report of new or worsening fever in the past 7 days; not gold standard measurement
Up to 24 months
Influenza Viral RNA Levels
Time Frame: Up to 24 months
Measured mean cycle threshold (Ct) value for each laboratory-confirmed influenza-positive specimen collected at baseline enrollment, by subtype. Ct values have an inverse relationship with viral load.
Up to 24 months
Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7
Time Frame: Up to 24 months
Measured at subject follow-up visits with nasal swabs provided to study staff; provided subject has not become lost to follow up.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2019

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (Actual)

October 28, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

May 23, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007800

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We do not currently expect to share specimens with outside investigators, but if compelling opportunities arise that will advance the overall objectives of this research, the Executive Committee of the study will consider such requests. They alone have the authority to make such decisions.

All biospecimens (nasal swabs) will be coded and identifiable through the study's main database. Any specimens shared with external investigators (if deemed appropriate by the Executive Committee) will have identifiers removed prior to sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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