FluSAFE: Flu SMS Alerts to Freeze Exposure

Influenza Clinical Trial

Official title:

FluSAFE: Flu SMS Alerts to Freeze Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274310
• Other study ID #: AAAR0955
• Secondary ID: 1R01AI127812-01
• Status: Completed
• Phase: N/A
• Start date: October 6, 2017
• Est. completion date: May 15, 2021

Study information

• Verified date: April 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1918
• Est. completion date: May 15, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Influenza
• Influenza, Human
• Influenza-like Illness
• Respiratory Tract Infections

Intervention

Behavioral:
• Educational text messages
Educational text message about ways to decrease household transmission of influenza and other respiratory infections

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Household transmission of symptomatic ILI/ARI	Cases of household members meeting symptomatic criteria for ILI/ARI	Up to 5 days
Secondary	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