Test-and-treat for Influenza in Homeless Shelters

Phase 4

Terminated

• Conditions: Respiratory Viral Infection; Influenza
• Interventions: Combination Product: Point-of-care molecular testing and treatment of influenza

• Registration Number: NCT04141917
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-28
• Study Start: 2019-11-15
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Results First Submitted: 2022-03-30
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-23
• Last Update Submitted: 2022-05-23
• Results First Posted: 2022-06-22
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1618

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Point-of-care molecular testing and treatment of influenza	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®) .

Primary Outcome Measures

Name	Time	Method
Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters	Up to 24 months	Number of participants/participant encounters with les than 48 hours between symptom onset until diagnosis with RT-PCR.
Feasibility of Implementation of Influenza Treatment in Shelters	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
Influenza Viral RNA Levels	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.
Number of Participants That Drop Out of Study	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
Number of Participants That Show Non-compliance With Study Drug	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).
Number of Laboratory-confirmed Influenza Cases That Report Fever	Up to 24 months	Based on self-report of new or worsening fever in the past 7 days; not gold standard measurement
Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7	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.

Trial Locations

Locations (9)

Mary's Place Burien; 🇺🇸 Burien, Washington, United States

Compass Housing Alliance at First Presbyterian; 🇺🇸 Seattle, Washington, United States

ROOTS Young Adult Shelter; 🇺🇸 Seattle, Washington, United States

Downtown Emergency Service Center Shelter; 🇺🇸 Seattle, Washington, United States

Compass Housing Alliance Blaine Center Men's Shelter; 🇺🇸 Seattle, Washington, United States

Mary's Place North Seattle; 🇺🇸 Seattle, Washington, United States

St Martin De Porres Shelter; 🇺🇸 Seattle, Washington, United States

Compass Housing Alliance Jan & Peter's Place Women's Shelter; 🇺🇸 Seattle, Washington, United States

Mary's Place White Center; 🇺🇸 Seattle, Washington, United States