FluSAFE: Flu SMS Alerts to Freeze Exposure

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.

Study Overview

• Status: Completed
• Conditions: Influenza; Acute Respiratory Infection; Influenza-like Illness
• Intervention / Treatment: Behavioral: Educational text messages

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 Type: Interventional
• Enrollment (Actual): 1918
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Educational text messages; Educational text message about ways to decrease household transmission of influenza and other respiratory infections
No Intervention: Surveillance-only arm; No intervention solely surveillance messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Household transmission of laboratory-confirmed influenza	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	Up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Household transmission of symptomatic ILI/ARI	Cases of household members meeting symptomatic criteria for ILI/ARI	Up to 5 days
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	Up to 5 days

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Melissa Stockwell, MD, MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): May 15, 2021

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Influenza; Text message; Acute Respiratory Infection; Influenza-like Illness
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Respiratory Tract Infections
• Other Study ID Numbers: AAAR0955; 1R01AI127812-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No