FluSAFE: Flu SMS Alerts to Freeze Exposure

NCT03274310 | Completed Results DMC

• 2 other identifiers: AAAR09551R01AI127812-01
• Study Type: interventional
• Target: 1,918
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Acute Respiratory Infection; Influenza-like Illness

Keywords

Influenza; Text message; Influenza-like Illness; Acute Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• Number of Laboratory-confirmed Influenza Infections

  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 Outcomes (2)

• Number of Cases of Household Members Meeting Symptomatic Criteria for ILI/ARI

  Up to 5 days

• Number of Infections of Non-influenza Respiratory Viruses

  Up to 5 days

Study Arms (2)

Surveillance + Education arm

EXPERIMENTAL

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

Surveillance-only arm

NO INTERVENTION

No intervention solely surveillance messages

Interventions

Educational text messages BEHAVIORAL

Educational text message about ways to decrease household transmission of influenza and other respiratory infections

Surveillance + Education arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Melissa Stockwell
• Organization: Columbia University Vagelos College of Physicians and Surgeons

mss2112@cumc.columbia.edu

2123425732

Study Officials

• Melissa Stockwell, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics and Population and Family Health

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 6, 2017
• Study Start: October 6, 2017
• Primary Completion: March 31, 2021
• Study Completion: May 15, 2021
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2025-01

Locations

US (1)