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Test-and-treat for Influenza in Homeless Shelters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04141917
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Helen Chu, 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.

Condition or disease Intervention/treatment Phase
Influenza Respiratory Viral Infection Combination Product: Point-of-care molecular testing and treatment of influenza Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Incidence of cases of influenza in shelters during the intervention period compared to the control period. [ Time Frame: Up to 24 months ]
    Calculated as the number of cases of laboratory-confirmed influenza among shelter residents per person-day of observations (person-days of observation will be based on the daily census at the shelter). The incidence during intervention periods will be compared to the incidence during non-intervention periods using general estimating equation models to control for clustering, differences in shelters, and time period.


Secondary Outcome Measures :
  1. Feasibility of implementation of point-of-care molecular testing and treatment of influenza in shelters, [ Time Frame: Up to 24 months ]
    Time between symptom onset until diagnosis

  2. Feasibility of implementation of influenza treatment in shelters [ Time Frame: Up to 24 months ]
    Time between symptom onset until treatment

  3. Cost effectiveness of test-and-treat intervention in shelters [ Time Frame: Up to 24 months ]
    Assessed using health resource utilization (including emergency department visits) and school and work absenteeism among influenza cases before and after the intervention, incorporating cost of test-and-treat infrastructure

  4. Proportion of participants that drop out of study [ Time Frame: Up to 24 months ]
    Measured as dropping out after providing consent

  5. Proportion 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.

  6. Total number of person-tests per census-day at shelters among residents that are eligible for testing [ Time Frame: Up to 24 months ]
    Census for each shelter available daily

  7. Symptom type, duration and severity among influenza-positive cases [ Time Frame: Up to 24 months ]
    Descriptive statistics of clinical manifestations of illness, stratified by demographic, comorbidity, and stain-specific data

  8. Point prevalence of clinical, demographic, and behavioral factors associated with asymptomatic influenza-positive cases [ Time Frame: Up to 24 months ]
    Monthly participation of asymptomatic subjects

  9. Proportion of laboratory-confirmed influenza cases that report fever [ Time Frame: Up to 24 months ]
    Based on self-report, not gold standard measurement

  10. Comparison of symptoms type, duration, and severity between season influenza vaccinated and unvaccinated subjects with an influenza-positive test result [ Time Frame: Up to 24 months ]
    Based on self-report

  11. Viral titer [ Time Frame: Up to 24 months ]
    Measured for each sample collection

  12. Proportion of samples with detectable influenza RNA virus at days 2/3 and days 5/6/7 [ Time Frame: Up to 24 months ]
    Provided subject has not become lost to follow up

  13. Proportion of cases in the shelter that are found via sequencing to be secondary cases, and proportion that are community-acquired [ Time Frame: Up to 24 months ]
    Assessed by genetic sequencing of influenza strains

  14. Emergence of antiviral resistance [ Time Frame: Up to 24 months ]
    Assessed by genetic sequencing of influenza strains



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141917


Contacts
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Contact: Julia H Rogers, MPHc 206-616-5958 jr66@uw.edu
Contact: Denise MCulloch, MD 206-616-5958 dmccull@uw.edu

Locations
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United States, Washington
Mary's Place Burien Recruiting
Burien, Washington, United States, 98146
Contact: Julia Rogers         
Compass Housing Alliance at First Presbyterian Recruiting
Seattle, Washington, United States, 98104
Contact: Julia Rogers         
Downtown Emergency Service Center Shelter Recruiting
Seattle, Washington, United States, 98104
Contact: Julia Rogers         
ROOTS Young Adult Shelter Recruiting
Seattle, Washington, United States, 98105
Contact: Julia Rogers         
Compass Housing Alliance Blaine Center Men's Shelter Recruiting
Seattle, Washington, United States, 98109
Contact: Julia Rogers         
Mary's Place North Seattle Recruiting
Seattle, Washington, United States, 98133
Contact: Julia Rogers         
St Martin De Porres Shelter Recruiting
Seattle, Washington, United States, 98134
Contact: Julia Rogers         
Compass Housing Alliance Jan & Peter's Place Women's Shelter Recruiting
Seattle, Washington, United States, 98144
Contact: Julia Rogers         
Mary's Place White Center Recruiting
Seattle, Washington, United States, 98146
Contact: Julia Rogers         
Sponsors and Collaborators
University of Washington
Genentech, Inc.
Investigators
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Principal Investigator: Helen Y Chu, MD, MPH University of Washington
Publications:
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Responsible Party: Helen Chu, Assistant Professor, School of Medicine: Division of Allergy & Infectious Diseases, University of Washington
ClinicalTrials.gov Identifier: NCT04141917    
Other Study ID Numbers: STUDY00007800
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helen Chu, University of Washington:
Tamiflu
Oseltamivir
Baloxavir
Influenza
Flu
Rapid Test
Xofluza
Additional relevant MeSH terms:
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Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases