Trial Outcomes & Findings for Test-and-treat for Influenza in Homeless Shelters (NCT NCT04141917)
NCT ID: NCT04141917
Last Updated: 2022-06-22
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
1618 participants
Primary outcome timeframe
Year 1 of the intervention (4.5 months)
Results posted on
2022-06-22
Participant Flow
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.
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.
Unit of analysis: Shelters
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Surveillance Year 1
STARTED
|
63 3
|
76 2
|
81 2
|
324 2
|
|
Surveillance Year 1
COMPLETED
|
63 3
|
76 2
|
81 2
|
324 2
|
|
Surveillance Year 1
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Surveillance + Test and Treat Year 1
STARTED
|
358 3
|
153 2
|
82 2
|
83 2
|
|
Surveillance + Test and Treat Year 1
COMPLETED
|
358 3
|
153 2
|
82 2
|
83 2
|
|
Surveillance + Test and Treat Year 1
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Summer Surveillance
STARTED
|
73 3
|
39 2
|
54 2
|
20 2
|
|
Summer Surveillance
COMPLETED
|
73 3
|
39 2
|
54 2
|
20 2
|
|
Summer Surveillance
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Surveillance Year 2
STARTED
|
3 3
|
3 2
|
10 2
|
7 2
|
|
Surveillance Year 2
COMPLETED
|
3 3
|
3 2
|
10 2
|
7 2
|
|
Surveillance Year 2
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Surveillance + Test and Treat Year 2
STARTED
|
62 3
|
13 2
|
3 2
|
3 2
|
|
Surveillance + Test and Treat Year 2
COMPLETED
|
62 3
|
13 2
|
3 2
|
3 2
|
|
Surveillance + Test and Treat Year 2
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Test-and-treat for Influenza in Homeless Shelters
Baseline characteristics by cohort
| Measure |
Standard Influenza Surveillance Period
n=853 Participants
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.
|
Point-of-care Molecular Testing and Treatment of Influenza Period
n=765 Participants
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.
|
Total
n=1618 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
85 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
727 Participants
n=99 Participants
|
667 Participants
n=107 Participants
|
1394 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
521 Participants
n=99 Participants
|
576 Participants
n=107 Participants
|
1097 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
323 Participants
n=99 Participants
|
181 Participants
n=107 Participants
|
504 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Other
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Prefer not to say
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Data missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
109 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
731 Participants
n=99 Participants
|
683 Participants
n=107 Participants
|
1414 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
14 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
231 Participants
n=99 Participants
|
191 Participants
n=107 Participants
|
422 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
370 Participants
n=99 Participants
|
355 Participants
n=107 Participants
|
725 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
95 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
99 Participants
n=99 Participants
|
96 Participants
n=107 Participants
|
195 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Year 1 of the intervention (4.5 months)Population: 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.
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.
Outcome measures
| Measure |
Standard Influenza Surveillance Period
n=363 Participants
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
n=371 Participants
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.
|
|---|---|---|
|
Number of Participants With Cases of Influenza in Shelters During the Intervention Period Compared to the Control Period
|
23 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: 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.
Number of participants/participant encounters with les than 48 hours between symptom onset until diagnosis with RT-PCR.
Outcome measures
| Measure |
Standard Influenza Surveillance Period
n=701 Participants
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
n=764 Participants
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.
|
|---|---|---|
|
Feasibility of Implementation of Point-of-care Molecular Testing and Treatment of Influenza in Shelters
|
266 Participants
|
308 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: 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.
Number of influenza-positive participants identified through on-site molecular testing in the intervention period that were treated with an antiviral
Outcome measures
| Measure |
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
n=21 Participants
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.
|
|---|---|---|
|
Feasibility of Implementation of Influenza Treatment in Shelters
|
—
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: 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.
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
Outcome measures
| Measure |
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
n=21 Participants
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.
|
|---|---|---|
|
Number of Participants That Drop Out of Study
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: 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.
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).
Outcome measures
| Measure |
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
n=6 Participants
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.
|
|---|---|---|
|
Number of Participants That Show Non-compliance With Study Drug
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: All influenza positive cases detected in study Years 1 and 2; there were no cases of influenza detected in year 2 of the study.
Based on self-report of new or worsening fever in the past 7 days; not gold standard measurement
Outcome measures
| Measure |
Standard Influenza Surveillance Period
n=23 Participants
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
n=32 Participants
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.
|
|---|---|---|
|
Number of Laboratory-confirmed Influenza Cases That Report Fever
|
12 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Standard Influenza Surveillance Period
n=23 Participants
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
n=32 Participants
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.
|
|---|---|---|
|
Influenza Viral RNA Levels
Influenza A
|
19.22 Cycle threshold value
Interval 16.5 to 22.19
|
21.21 Cycle threshold value
Interval 17.38 to 25.34
|
|
Influenza Viral RNA Levels
Influenza B
|
22.08 Cycle threshold value
Interval 18.47 to 26.26
|
18.51 Cycle threshold value
Interval 15.87 to 22.44
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: 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.
Measured at subject follow-up visits with nasal swabs provided to study staff; provided subject has not become lost to follow up.
Outcome measures
| Measure |
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
n=21 Participants
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.
|
|---|---|---|
|
Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7
Detectable at day 2/3
|
—
|
7 Participants
|
|
Number of Samples With Detectable Influenza RNA Virus at Days 2/3 and Days 5/6/7
Detectable at day 5/6/7
|
—
|
0 Participants
|
Adverse Events
Standard Influenza Surveillance Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Point-of-care Molecular Testing and Treatment of Influenza Period
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Influenza Surveillance Period
n=853 participants at risk
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
n=765 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea or vomiting
|
0.00%
0/853 • 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).
|
0.26%
2/765 • 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).
|
|
Ear and labyrinth disorders
Ear pain or ear discharge
|
0.00%
0/853 • 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).
|
0.13%
1/765 • 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).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/853 • 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).
|
0.26%
2/765 • 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).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/853 • 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).
|
0.13%
1/765 • 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).
|
|
General disorders
Nasopharyngitis
|
0.00%
0/853 • 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).
|
0.13%
1/765 • 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).
|
|
General disorders
Headache
|
0.00%
0/853 • 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).
|
0.13%
1/765 • 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).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/853 • 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).
|
0.13%
1/765 • 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).
|
|
Immune system disorders
Inflamed mucous membrane
|
0.00%
0/853 • 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).
|
0.13%
1/765 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place