Clinical trial NCT03274310: FluSAFE: Flu SMS Alerts to Freeze Exposure
Official title: FluSAFE: Flu SMS Alerts to Freeze Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Acute Respiratory Infection
Influenza-like Illness
Keywords: Influenza
Text message
Influenza-like Illness
Acute Respiratory Infection
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2017-09-06
Enrollment: 1918
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Laboratory-confirmed Influenza Infections
timeFrame: Up to 5 days
Secondary outcomes:
measure: Number of Cases of Household Members Meeting Symptomatic Criteria for ILI/ARI
timeFrame: Up to 5 days
measure: Number of Infections of Non-influenza Respiratory Viruses
timeFrame: Up to 5 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: