FluSAFE: Flu SMS Alerts to Freeze Exposure

NCT ID: NCT03274310

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1918 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-06
• Study Completion Date: 2021-05-15

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.

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.

Conditions

Influenza; Acute Respiratory Infection; Influenza-like Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Educational text messages

Intervention Type: BEHAVIORAL

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

Surveillance-only arm

No intervention solely surveillance messages

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational text messages

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Melissa Stockwell

Associate Professor of Pediatrics and Population and Family Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa Stockwell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01AI127812-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR0955

Identifier Type: -

Identifier Source: org_study_id