Test-and-treat for Influenza in Homeless Shelters

University of Washington

Status and phase: Terminated; Phase 4

Conditions: Influenza; Respiratory Viral Infection

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04141917

STUDY00007800

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,618 patients

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,618 participants in 2 patient groups

Standard influenza surveillance

No Intervention group

Description:

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 group

Description:

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®) .

Treatment:

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