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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04141917|
Recruitment Status : Terminated (Operational futility (i.e. near zero circulation of influenza in the community during year 2))
First Posted : October 28, 2019
Last Update Posted : July 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Influenza Respiratory Viral Infection||Combination Product: Point-of-care molecular testing and treatment of influenza||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||1222 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||March 31, 2021|
|Actual Study Completion Date :||March 31, 2021|
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.
- 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.
- 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
- Feasibility of implementation of influenza treatment in shelters [ Time Frame: Up to 24 months ]Time between symptom onset until treatment
- 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
- Proportion of participants that drop out of study [ Time Frame: Up to 24 months ]Measured as dropping out after providing consent
- 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.
- 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
- 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
- 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
- Proportion of laboratory-confirmed influenza cases that report fever [ Time Frame: Up to 24 months ]Based on self-report, not gold standard measurement
- 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
- Viral titer [ Time Frame: Up to 24 months ]Measured for each sample collection
- 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
- 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
- Emergence of antiviral resistance [ Time Frame: Up to 24 months ]Assessed by genetic sequencing of influenza strains
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
|United States, Washington|
|Mary's Place Burien|
|Burien, Washington, United States, 98146|
|Compass Housing Alliance at First Presbyterian|
|Seattle, Washington, United States, 98104|
|Downtown Emergency Service Center Shelter|
|Seattle, Washington, United States, 98104|
|ROOTS Young Adult Shelter|
|Seattle, Washington, United States, 98105|
|Compass Housing Alliance Blaine Center Men's Shelter|
|Seattle, Washington, United States, 98109|
|Mary's Place North Seattle|
|Seattle, Washington, United States, 98133|
|St Martin De Porres Shelter|
|Seattle, Washington, United States, 98134|
|Compass Housing Alliance Jan & Peter's Place Women's Shelter|
|Seattle, Washington, United States, 98144|
|Mary's Place White Center|
|Seattle, Washington, United States, 98146|
|Principal Investigator:||Helen Y Chu, MD, MPH||University of Washington|