FluSAFE: Flu SMS Alerts to Freeze Exposure

Study Overview
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Brief Summary
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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
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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.

Official Title
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FluSAFE: Flu SMS Alerts to Freeze Exposure

Conditions
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Influenza, Acute Respiratory Infection, Influenza-like Illness

Intervention / Treatment
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* Behavioral: Educational text messages


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surveillance + Education arm<br>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<br>* Educational text message about ways to decrease household transmission of influenza and other respiratory infections<br>|
| No Intervention: Surveillance-only arm<br>No intervention solely surveillance messages | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Household transmission of symptomatic ILI/ARI | Cases of household members meeting symptomatic criteria for ILI/ARI | Up to 5 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Text message, Influenza-like Illness, Acute Respiratory Infection