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OpenTrials
Completed

NCT Number: NCT03274310

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.

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Key information

Conditions

Influenza Acute Respiratory Infection Infections Influenza, Human Influenza-like Illness Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational text messages

Behavioral

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

Primary outcomes

  1. Number of Laboratory-confirmed Influenza Infections

    Time frame: 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 outcomes

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

    Time frame: Up to 5 days

    The 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.

  2. Number of Infections of Non-influenza Respiratory Viruses

    Time frame: Up to 5 days

    This 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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2017
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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