Trial Outcomes & Findings for FluSAFE: Flu SMS Alerts to Freeze Exposure (NCT NCT03274310)
NCT ID: NCT03274310
Last Updated: 2025-01-16
Results Overview
One self-swab of the index case and self-swabs of other household members will be analyzed using reverse transcription polymerase chain reaction (RT-PCR) to identify household transmission of laboratory-confirmed influenza.
COMPLETED
NA
1918 participants
Up to 5 days
2025-01-16
Participant Flow
Unit of analysis: households
Participant milestones
| Measure |
Surveillance + Education Arm
Receipt of educational text message about ways to decrease household transmission of influenza and other respiratory infections in addition to surveillance messages
Educational text messages: Educational text message about ways to decrease household transmission of influenza and other respiratory infections
|
Surveillance-only Arm
No intervention solely surveillance messages
|
|---|---|---|
|
Overall Study
STARTED
|
959 203
|
959 208
|
|
Overall Study
COMPLETED
|
959 203
|
959 208
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FluSAFE: Flu SMS Alerts to Freeze Exposure
Baseline characteristics by cohort
| Measure |
Surveillance + Education Arm
n=959 Participants
Receipt of educational text message about ways to decrease household transmission of influenza and other respiratory infections in addition to surveillance messages
Educational text messages: Educational text message about ways to decrease household transmission of influenza and other respiratory infections
|
Surveillance-only Arm
n=959 Participants
No intervention solely surveillance messages
|
Total
n=1918 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · <18 years
|
468 Participants
n=5 Participants
|
448 Participants
n=7 Participants
|
916 Participants
n=5 Participants
|
|
Age, Customized
Age · 18 years and over
|
491 Participants
n=5 Participants
|
511 Participants
n=7 Participants
|
1002 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
546 Participants
n=5 Participants
|
518 Participants
n=7 Participants
|
1064 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
413 Participants
n=5 Participants
|
441 Participants
n=7 Participants
|
854 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
133 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
824 Participants
n=5 Participants
|
827 Participants
n=7 Participants
|
1651 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 daysOne self-swab of the index case and self-swabs of other household members will be analyzed using reverse transcription polymerase chain reaction (RT-PCR) to identify household transmission of laboratory-confirmed influenza.
Outcome measures
| Measure |
Surveillance + Education Arm
n=959 Participants
Receipt of educational text message about ways to decrease household transmission of influenza and other respiratory infections in addition to surveillance messages
Educational text messages: Educational text message about ways to decrease household transmission of influenza and other respiratory infections
|
Surveillance-only Arm
n=959 Participants
No intervention solely surveillance messages
|
|---|---|---|
|
Number of Laboratory-confirmed Influenza Infections
|
.22 infections
Standard Error 0.04
|
.14 infections
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Up to 5 daysThe CDC-provided case definition for ARI is presence of at least two of the following: 1) rhinorrhea/nasal congestion; 2) sore throat; 3) cough; 4) fever/feverishness; 5) myalgia. The ILI definition is at least two of the following signs and symptoms: fever, cough, headache, sore throat, or myalgia.
Outcome measures
| Measure |
Surveillance + Education Arm
n=959 Participants
Receipt of educational text message about ways to decrease household transmission of influenza and other respiratory infections in addition to surveillance messages
Educational text messages: Educational text message about ways to decrease household transmission of influenza and other respiratory infections
|
Surveillance-only Arm
n=959 Participants
No intervention solely surveillance messages
|
|---|---|---|
|
Number of Cases of Household Members Meeting Symptomatic Criteria for ILI/ARI
|
.20 infections
Standard Error .01
|
.19 infections
Standard Error .01
|
SECONDARY outcome
Timeframe: Up to 5 daysThis outcome will measure household transmission of non-influenza respiratory viruses. One self-swab of the index case and self-swabs of other household members will be analyzed using RT-PCR to identify household transmission of non-influenza respiratory viruses
Outcome measures
| Measure |
Surveillance + Education Arm
n=959 Participants
Receipt of educational text message about ways to decrease household transmission of influenza and other respiratory infections in addition to surveillance messages
Educational text messages: Educational text message about ways to decrease household transmission of influenza and other respiratory infections
|
Surveillance-only Arm
n=959 Participants
No intervention solely surveillance messages
|
|---|---|---|
|
Number of Infections of Non-influenza Respiratory Viruses
|
.27 infections
Standard Error .02
|
.23 infections
Standard Error .02
|
Adverse Events
Surveillance + Education Arm
Surveillance-only Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Melissa Stockwell
Columbia University Vagelos College of Physicians and Surgeons
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place