<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03274310</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR0955</org_study_id>
    <secondary_id>1R01AI127812-01</secondary_id>
    <nct_id>NCT03274310</nct_id>
  </id_info>
  <brief_title>FluSAFE: Flu SMS Alerts to Freeze Exposure</brief_title>
  <official_title>FluSAFE: Flu SMS Alerts to Freeze Exposure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Influenza infection results in an estimated 31 million outpatient visits, 55,000 to 974,200&#xD;
      hospitalizations, and 3,000 to 49,000 deaths. Membership in household in which someone else&#xD;
      has influenza is the major risk factor for contracting influenza. The household secondary&#xD;
      attack rate (SAR) is as high as 19% based on laboratory-confirmed influenza and 30% based on&#xD;
      symptoms. Non-pharmaceutical preventive measures, including education, may play a role in&#xD;
      decreasing transmission, but are only effective if started within 36 hours of symptom onset&#xD;
      in index cases. Yet, most interventions are delayed because they are not initiated until care&#xD;
      is sought. The investigators have demonstrated in one primarily Latino, urban community&#xD;
      sample, that text messaging can be used to rapidly identify community members with&#xD;
      influenza-like illness (ILI) early in an illness. This early identification would enable&#xD;
      implementation of an educational intervention in the optimal time frame to reduce influenza&#xD;
      transmission. Providing education within a text message is a proven successful strategy to&#xD;
      influence behavior. Text messaging itself is scalable, low-cost, and can be used in low&#xD;
      literacy populations. However, using text-message based surveillance to trigger a real-time&#xD;
      text-message behavioral educational intervention to decrease household influenza transmission&#xD;
      has not been assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will enroll approximately 400 households with ≥1 child recruited from four&#xD;
      contiguous communities in New York City. Households will be randomized, stratified by&#xD;
      community 1:1 to receive surveillance-only (no text message education) vs. surveillance plus&#xD;
      text message educational intervention. For symptom surveillance, households in both arms will&#xD;
      receive text messages 3x/week during each influenza season and report if someone in the&#xD;
      household has ILI symptoms. For those in the educational intervention arm, when an ILI/acute&#xD;
      respiratory infections (ARI) is reported, a series of educational text messages will be sent&#xD;
      with information to decrease household transmission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 6, 2017</start_date>
  <completion_date type="Actual">May 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Household transmission of laboratory-confirmed influenza</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Household transmission of symptomatic ILI/ARI</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>Cases of household members meeting symptomatic criteria for ILI/ARI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Household transmission of non-influenza respiratory viruses</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1918</enrollment>
  <condition>Influenza</condition>
  <condition>Acute Respiratory Infection</condition>
  <condition>Influenza-like Illness</condition>
  <arm_group>
    <arm_group_label>Surveillance + Education arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receipt of educational text message about ways to decrease household transmission of influenza and other respiratory infections in addition to surveillance messages</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surveillance-only arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention solely surveillance messages</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational text messages</intervention_name>
    <description>Educational text message about ways to decrease household transmission of influenza and other respiratory infections</description>
    <arm_group_label>Surveillance + Education arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥3 persons per household&#xD;
&#xD;
          -  At least one person who is less than 18 years old&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  Household reporter has cell phone with text messaging capabilities&#xD;
&#xD;
          -  Household reporter willing to use text messages to report&#xD;
&#xD;
          -  Reside within study neighborhoods in New York City&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Intention to move away from New York City area in &lt;12 months&#xD;
&#xD;
          -  Language other than English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa Stockwell, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>April 9, 2022</last_update_submitted>
  <last_update_submitted_qc>April 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Melissa Stockwell</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics and Population and Family Health</investigator_title>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Text message</keyword>
  <keyword>Influenza-like Illness</keyword>
  <keyword>Acute Respiratory Infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03274310
org study id: AAAR0955
secondary id: 1R01AI127812-01
nct id: NCT03274310
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Household transmission of laboratory-confirmed influenza
time frame: Up to 5 days
description: 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
measure: Household transmission of symptomatic ILI/ARI
time frame: Up to 5 days
description: Cases of household members meeting symptomatic criteria for ILI/ARI
measure: Household transmission of non-influenza respiratory viruses
time frame: Up to 5 days
description: 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
arm group label: Surveillance + Education arm
arm group type: Experimental
description: Receipt of educational text message about ways to decrease household transmission of influenza and other respiratory infections in addition to surveillance messages
arm group label: Surveillance-only arm
arm group type: No Intervention
description: No intervention solely surveillance messages
intervention type: Behavioral
intervention name: Educational text messages
description: Educational text message about ways to decrease household transmission of influenza and other respiratory infections
arm group label: Surveillance + Education arm
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Melissa Stockwell, MD, MPH
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Melissa Stockwell
investigator title: Associate Professor of Pediatrics and Population and Family Health
mesh term: Influenza, Human
mesh term: Respiratory Tract Infections
sharing ipd: Undecided