FluSAFE: Flu SMS Alerts to Freeze Exposure

Not Applicable

Completed

• Conditions: Acute Respiratory Infection; Influenza; Influenza-like Illness
• Interventions: Behavioral: Educational text messages

• Registration Number: NCT03274310
• Lead Sponsor: Columbia University

Brief Summary

Influenza infection results in an estimated 31 million outpatient visits, 55,000 to 974,200 hospitalizations, and 3,000 to 49,000 deaths. Membership in household in which someone else has influenza is the major risk factor for contracting influenza. The household secondary attack rate (SAR) is as high as 19% based on laboratory-confirmed influenza and 30% based on symptoms. Non-pharmaceutical preventive measures, including education, may play a role in decreasing transmission, but are only effective if started within 36 hours of symptom onset in index cases. Yet, most interventions are delayed because they are not initiated until care is sought. The investigators have demonstrated in one primarily Latino, urban community sample, that text messaging can be used to rapidly identify community members with influenza-like illness (ILI) early in an illness. This early identification would enable implementation of an educational intervention in the optimal time frame to reduce influenza transmission. Providing education within a text message is a proven successful strategy to influence behavior. Text messaging itself is scalable, low-cost, and can be used in low literacy populations. However, using text-message based surveillance to trigger a real-time text-message behavioral educational intervention to decrease household influenza transmission has not been assessed.

Detailed Description

The study will enroll approximately 400 households with ≥1 child recruited from four contiguous communities in New York City. Households will be randomized, stratified by community 1:1 to receive surveillance-only (no text message education) vs. surveillance plus text message educational intervention. For symptom surveillance, households in both arms will receive text messages 3x/week during each influenza season and report if someone in the household has ILI symptoms. For those in the educational intervention arm, when an ILI/acute respiratory infections (ARI) is reported, a series of educational text messages will be sent with information to decrease household transmission.

Study Timeline

• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-04
• Study First Posted: 2017-09-06
• Study Start: 2017-10-06
• Primary Completion: 2021-03-31
• Study Completion: 2021-05-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1918

Inclusion Criteria

• ≥3 persons per household
• At least one person who is less than 18 years old
• English or Spanish speaking
• Household reporter has cell phone with text messaging capabilities
• Household reporter willing to use text messages to report
• Reside within study neighborhoods in New York City

Exclusion Criteria

• Intention to move away from New York City area in <12 months
• Language other than English or Spanish

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surveillance + Education arm	Educational text messages	Receipt of educational text message about ways to decrease household transmission of influenza and other respiratory infections in addition to surveillance messages

Primary Outcome Measures

Name	Time	Method
Household transmission of laboratory-confirmed influenza	Up to 5 days	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

Secondary Outcome Measures

Name	Time	Method
Household transmission of symptomatic ILI/ARI	Up to 5 days	Cases of household members meeting symptomatic criteria for ILI/ARI
Household transmission of non-influenza respiratory viruses	Up to 5 days	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

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States