Test-and-treat for Influenza in Homeless Shelters

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1618 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2021-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza Respiratory Viral Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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®) .

Group Type ACTIVE_COMPARATOR

Point-of-care molecular testing and treatment of influenza

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No