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Operational futility (i.e. near zero circulation of influenza in the community during year 2)
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard influenza surveillance | No Intervention | 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 | 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®) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-care molecular testing and treatment of influenza | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period | 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. | Year 1 of the intervention (4.5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters | Number of participants/participant encounters with les than 48 hours between symptom onset until diagnosis with RT-PCR. | Up to 24 months |
| Feasibility of Implementation of Influenza Treatment in Shelters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Y Chu, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mary's Place Burien | Burien | Washington | 98146 | United States | ||
| Compass Housing Alliance at First Presbyterian |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30184455 | Background | Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197. | |
| 31211675 |
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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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Since shelters were randomized to receive the intervention in cascading intervals as part of a stepped-wedge approach rather than participants themselves, participant study encounters rather than unique participants serve as the baseline unit of measure. Since participants are cross-sectionally recruited and not followed longitudinally unless they received antiviral treatment (for 1 week), there is no dropout between study periods, only new enrollments.
Participants for this test-and-treat intervention were recruited from homeless shelters across King County, WA and implemented over two respiratory virus seasons (11/15/2019 - 3/31/2020; 11/2/2020 - 3/31/2021). In Year 1, 9 shelters were randomized to receive the intervention in a stepped-wedge approach. Due to the impact of COVID-19, residents from 6 shelters were relocated to new facilities for social distancing reasons. Re-randomization, including these new facilities, occurred Year 2.
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A | 5 months of standard surveillance + test and treat protocol Standard influenza surveillance period: 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 period: 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®) . 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. |
| FG001 | Sequence B | 1 month standard surveillance then 4 months standard surveillance + test and treat protocol Standard influenza surveillance period: 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 period: 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®) . 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. |
| FG002 | Sequence C | 2 months standard surveillance then 3 months standard surveillance + test and treat protocol Standard influenza surveillance period: 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 period: 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®) . 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. |
| FG003 | Sequence D | 3 months standard surveillance then 2 months standard surveillance + test and treat protocol Standard influenza surveillance period: 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 period: 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®) . 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Surveillance Year 1 |
| |||||||||||||
| Surveillance + Test and Treat Year 1 |
| |||||||||||||
| Summer Surveillance |
| |||||||||||||
| Surveillance Year 2 |
| |||||||||||||
| Surveillance + Test and Treat Year 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Influenza Surveillance Period | 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. These are all participants that enrolled when only standard surveillance, no intervention, was available at their shelter given the randomized sequence. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period | 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. | Due to the impact of COVID-19 mitigation efforts on reduced influenza transmission in Year 2 of the study and subsequent early stop due to operational futility, the analysis population for the primary outcome only includes unique participants who enrolled in Year 1 of the study (11/15/19 - 3/31/20). For this primary outcome measure, we used the number of unique participants in Year 1 as the denominator rather than all participant enrollments. | Posted | Count of Participants | Participants | Year 1 of the intervention (4.5 months) |
|
Adverse event data were collected during the intervention periods implemented over two respiratory virus seasons: 11/15/19 - 3/31/20 and 11/2/20 - 3/31/21 (9 months total)
Adverse event data, including symptom logs, were collected from trial participants that had follow-up visits 2/3 days and 5/6/7 days post-treatment. Adverse event data was not systematically collected from standard surveillance participants or from participants in the intervention period that did not participate in the trial component (on-site testing plus receipt of antiviral of influenza-positive).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Influenza Surveillance Period | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea or vomiting | Gastrointestinal disorders | Systematic Assessment |
Decline in influenza activity following the advent of SARS-CoV-2 public health mitigation measures led to early termination of study for operational futility purposes. Low infection detection and study power after year 1 also limited our ability to conduct statistical analyses on several intended secondary outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helen Chu | University of Washington | 206-685-8702 | helenchu@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2022 | Mar 30, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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|
Number of influenza-positive participants identified through on-site molecular testing in the intervention period that were treated with an antiviral |
| Up to 24 months |
| Number of Participants That Drop Out of Study | 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 | Up to 24 months |
| Number of Participants That Show Non-compliance With Study Drug | 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). | Up to 24 months |
| Number of Laboratory-confirmed Influenza Cases That Report Fever | Based on self-report of new or worsening fever in the past 7 days; not gold standard measurement | Up to 24 months |
| Influenza Viral RNA Levels | 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. | Up to 24 months |
| Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7 | Measured at subject follow-up visits with nasal swabs provided to study staff; provided subject has not become lost to follow up. | Up to 24 months |
| Seattle |
| Washington |
| 98104 |
| United States |
| Downtown Emergency Service Center Shelter | Seattle | Washington | 98104 | United States |
| ROOTS Young Adult Shelter | Seattle | Washington | 98105 | United States |
| Compass Housing Alliance Blaine Center Men's Shelter | Seattle | Washington | 98109 | United States |
| Mary's Place North Seattle | Seattle | Washington | 98133 | United States |
| St Martin De Porres Shelter | Seattle | Washington | 98134 | United States |
| Compass Housing Alliance Jan & Peter's Place Women's Shelter | Seattle | Washington | 98144 | United States |
| Mary's Place White Center | Seattle | Washington | 98146 | United States |
| Boonyaratanakornkit J, Ekici S, Magaret A, Gustafson K, Scott E, Haglund M, Kuypers J, Pergamit R, Lynch J, Chu HY. Respiratory Syncytial Virus Infection in Homeless Populations, Washington, USA. Emerg Infect Dis. 2019 Jul;25(7):1408-1411. doi: 10.3201/eid2507.181261. |
| 9103130 | Background | Hwang SW, Orav EJ, O'Connell JJ, Lebow JM, Brennan TA. Causes of death in homeless adults in Boston. Ann Intern Med. 1997 Apr 15;126(8):625-8. doi: 10.7326/0003-4819-126-8-199704150-00007. |
| 24499605 | Background | Thiberville SD, Salez N, Benkouiten S, Badiaga S, Charrel R, Brouqui P. Respiratory viruses within homeless shelters in Marseille, France. BMC Res Notes. 2014 Feb 5;7:81. doi: 10.1186/1756-0500-7-81. |
| 36276877 | Derived | Cox SN, Rogers JH, Thuo NB, Meehan A, Link AC, Lo NK, Manns BJ, Chow EJ, Al Achkar M, Hughes JP, Rolfes MA, Mosites E, Chu HY. Trends and factors associated with change in COVID-19 vaccination intent among residents and staff in six Seattle homeless shelters, March 2020 to August 2021. Vaccine X. 2022 Dec;12:100232. doi: 10.1016/j.jvacx.2022.100232. Epub 2022 Oct 19. |
| 35749582 | Derived | Chow EJ, Casto AM, Roychoudhury P, Han PD, Xie H, Pfau B, Nguyen TV, Sereewit J, Rogers JH, Cox SN, Wolf CR, Rolfes MA, Mosites E, Uyeki TM, Greninger AL, Hughes JP, Shim MM, Sugg N, Duchin JS, Starita LM, Englund JA, Chu HY. The Clinical and Genomic Epidemiology of Rhinovirus in Homeless Shelters-King County, Washington. J Infect Dis. 2022 Oct 7;226(Suppl 3):S304-S314. doi: 10.1093/infdis/jiac239. |
| 34863618 | Derived | Rogers JH, Cox SN, Hughes JP, Link AC, Chow EJ, Fosse I, Lukoff M, Shim MM, Uyeki TM, Ogokeh C, Jackson ML, Boeckh M, Englund JA, Mosites E, Rolfes MA, Chu HY. Trends in COVID-19 vaccination intent and factors associated with deliberation and reluctance among adult homeless shelter residents and staff, 1 November 2020 to 28 February 2021 - King County, Washington. Vaccine. 2022 Jan 3;40(1):122-132. doi: 10.1016/j.vaccine.2021.11.026. Epub 2021 Nov 15. |
| 33228787 | Derived | Newman KL, Rogers JH, McCulloch D, Wilcox N, Englund JA, Boeckh M, Uyeki TM, Jackson ML, Starita L, Hughes JP, Chu HY; Seattle Flu Study Investigators. Point-of-care molecular testing and antiviral treatment of influenza in residents of homeless shelters in Seattle, WA: study protocol for a stepped-wedge cluster-randomized controlled trial. Trials. 2020 Nov 23;21(1):956. doi: 10.1186/s13063-020-04871-5. |
| 32931328 | Derived | Rogers JH, Link AC, McCulloch D, Brandstetter E, Newman KL, Jackson ML, Hughes JP, Englund JA, Boeckh M, Sugg N, Ilcisin M, Sibley TR, Fay K, Lee J, Han P, Truong M, Richardson M, Nickerson DA, Starita LM, Bedford T, Chu HY; Seattle Flu Study Investigators. Characteristics of COVID-19 in Homeless Shelters : A Community-Based Surveillance Study. Ann Intern Med. 2021 Jan;174(1):42-49. doi: 10.7326/M20-3799. Epub 2020 Sep 15. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Point-of-care Molecular Testing and Treatment of Influenza Period | 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®) . 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. These are all participants that enrolled when both standard surveillance and the intervention was available at their shelter given the randomized sequence. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Point-of-care Molecular Testing and Treatment of Influenza Period | 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®) . 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. |
|
|
|
| Secondary | Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters | Number of participants/participant encounters with les than 48 hours between symptom onset until diagnosis with RT-PCR. | Includes all participant encounters from study Years 1 and 2. 153 participant encounters were missing this data because they were asymptomatic enrollments conducted once monthly at all shelters between 11/15/2019 and 3/31/2020. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| Secondary | Feasibility of Implementation of Influenza Treatment in Shelters | Number of influenza-positive participants identified through on-site molecular testing in the intervention period that were treated with an antiviral | This outcome can only be assessed among participants enrollments from the intervention period as those in the control period ("standard influenza surveillance") were not eligible for antiviral treatment. Those that reported symptom onset ≥48 hours that were enrolled in the intervention period were dropped from the overall number of participants analyzed. The analysis population includes only influenza-positive cases that were detected using an on-site molecular test. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| Secondary | Number of Participants That Drop Out of Study | 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 | Only participant enrollments from the intervention period that tested positive for influenza at baseline enrollment with an on-site molecular test and received an antiviral are included in this analysis population as participant enrollments under the standard influenza surveillance period did not receive follow-up. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| Secondary | Number of Participants That Show Non-compliance With Study Drug | 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). | This analysis population includes all participants that received oseltamivir as an antiviral and returned for at least one follow-up study visit when a number of doses of the medication was reported to study staff. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| Secondary | Number of Laboratory-confirmed Influenza Cases That Report Fever | Based on self-report of new or worsening fever in the past 7 days; not gold standard measurement | All influenza positive cases detected in study Years 1 and 2; there were no cases of influenza detected in year 2 of the study. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| Secondary | Influenza Viral RNA Levels | 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. | All influenza-positive specimen detected through RT-PCR in study Years 1 and 2. One individual in the standard surveillance period was coinfected with both Influenza A and Influenza B, therefore these row numbers are not mutually exclusive. | Posted | Mean | Inter-Quartile Range | Cycle threshold value | Up to 24 months |
|
|
|
| Secondary | Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7 | Measured at subject follow-up visits with nasal swabs provided to study staff; provided subject has not become lost to follow up. | Only includes influenza-positive samples from participant enrollments collected in the intervention period and detected with an on-site molecular test. Of the 21 participants that received an antiviral and, according to the protocol, should have returned for follow-up sample collect and study visits, only 14 returned on day 2/3 and only 1 returned for day 2/3 and day 5/6/7 study visits. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| 0 |
| 853 |
| 0 |
| 853 |
| 0 |
| 853 |
| EG001 | Point-of-care Molecular Testing and Treatment of Influenza Period | 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®) . 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. | 0 | 765 | 0 | 765 | 5 | 765 |
| Ear pain or ear discharge | Ear and labyrinth disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasopharyngitis | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Delirium | Psychiatric disorders | Systematic Assessment |
|
| Inflamed mucous membrane | Immune system disorders | Systematic Assessment |
|
Not provided
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Influenza B |
|
|
| Detectable at day 5/6/7 |
|
|