Acute Respiratory Infection, Influenza, Influenza-like Illness
Conditions
Keywords
Influenza, Text message, Influenza-like Illness, Acute Respiratory Infection
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.
Interventions
BEHAVIORALEducational text messages
Educational text message about ways to decrease household transmission of influenza and other respiratory infections
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Laboratory-confirmed Influenza Infections | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Cases of Household Members Meeting Symptomatic Criteria for ILI/ARI | Up to 5 days | The CDC-provided case definition for ARI is presence of at least two of the following: 1) rhinorrhea/nasal congestion; 2) sore throat; 3) cough; 4) fever/feverishness; 5) myalgia. The ILI definition is at least two of the following signs and symptoms: fever, cough, headache, sore throat, or myalgia. |
| Number of Infections of Non-influenza Respiratory Viruses | Up to 5 days | This outcome will measure 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Educational text messages: Educational text message about ways to decrease household transmission of influenza and other respiratory infections | 959 |
| Surveillance-only Arm No intervention solely surveillance messages | 959 |
| Total | 1,918 |
Baseline characteristics
| Characteristic | Surveillance + Education Arm | Surveillance-only Arm | Total |
|---|---|---|---|
| Age, Customized Age <18 years | 468 Participants | 448 Participants | 916 Participants |
| Age, Customized Age 18 years and over | 491 Participants | 511 Participants | 1002 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 133 Participants | 132 Participants | 265 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 824 Participants | 827 Participants | 1651 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 546 Participants | 518 Participants | 1064 Participants |
| Sex: Female, Male Male | 413 Participants | 441 Participants | 854 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 959 | 0 / 959 |
| other Total, other adverse events | 0 / 959 | 0 / 959 |
| serious Total, serious adverse events | 0 / 959 | 0 / 959 |
Outcome results
Primary
Number of Laboratory-confirmed Influenza Infections
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.
Time frame: Up to 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surveillance + Education Arm | Number of Laboratory-confirmed Influenza Infections | .22 infections | Standard Error 0.04 |
| Surveillance-only Arm | Number of Laboratory-confirmed Influenza Infections | .14 infections | Standard Error 0.05 |
Secondary
Number of Cases of Household Members Meeting Symptomatic Criteria for ILI/ARI
The CDC-provided case definition for ARI is presence of at least two of the following: 1) rhinorrhea/nasal congestion; 2) sore throat; 3) cough; 4) fever/feverishness; 5) myalgia. The ILI definition is at least two of the following signs and symptoms: fever, cough, headache, sore throat, or myalgia.
Time frame: Up to 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surveillance + Education Arm | Number of Cases of Household Members Meeting Symptomatic Criteria for ILI/ARI | .20 infections | Standard Error 0.01 |
| Surveillance-only Arm | Number of Cases of Household Members Meeting Symptomatic Criteria for ILI/ARI | .19 infections | Standard Error 0.01 |
Secondary
Number of Infections of Non-influenza Respiratory Viruses
This outcome will measure 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
Time frame: Up to 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Surveillance + Education Arm | Number of Infections of Non-influenza Respiratory Viruses | .27 infections | Standard Error 0.02 |
| Surveillance-only Arm | Number of Infections of Non-influenza Respiratory Viruses | .23 infections | Standard Error 0.02 |