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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AI127812-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surveillance + Education arm | Experimental | Receipt of educational text message about ways to decrease household transmission of influenza and other respiratory infections in addition to surveillance messages |
|
| Surveillance-only arm | No Intervention | No intervention solely surveillance messages |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational text messages | Behavioral | Educational text message about ways to decrease household transmission of influenza and other respiratory infections |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 days |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Stockwell, MD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Surveillance-only Arm | No intervention solely surveillance messages |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | infections | Up to 5 days |
|
5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Stockwell | Columbia University Vagelos College of Physicians and Surgeons | 2123425732 | mss2112@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2020 | Jul 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| 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 | Up to 5 days |
| BG001 |
| Surveillance-only Arm |
No intervention solely surveillance messages |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
No intervention solely surveillance messages
|
|
| 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. | Posted | Mean | Standard Error | infections | Up to 5 days |
|
|
|
| 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 | Posted | Mean | Standard Error | infections | Up to 5 days |
|
|
|
| 0 |
| 959 |
| 0 |
| 959 |
| 0 |
| 959 |
| EG001 | Surveillance-only Arm | No intervention solely surveillance messages | 0 | 959 | 0 | 959 | 0 | 959 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |