FluSAFE: Flu SMS Alerts to Freeze Exposure

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT03274310
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational text messages
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1918 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
FluSAFE: Flu SMS Alerts to Freeze Exposure
Actual Study Start Date :
Oct 6, 2017
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
May 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Household transmission of symptomatic ILI/ARI [Up to 5 days]

    Cases of household members meeting symptomatic criteria for ILI/ARI

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University Medical Center New York New York United States 10032

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Melissa Stockwell, MD, MPH, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Melissa Stockwell, Associate Professor of Pediatrics and Population and Family Health, Columbia University
ClinicalTrials.gov Identifier:
NCT03274310
Other Study ID Numbers:
  • AAAR0955
  • 1R01AI127812-01
First Posted:
Sep 6, 2017
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Melissa Stockwell, Associate Professor of Pediatrics and Population and Family Health, Columbia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022