xml: <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/NCT05993260</url>
    </required_header>
    <id_info>
      <org_study_id>2021035</org_study_id>
      <nct_id>NCT05993260</nct_id>
    </id_info>
    <brief_title>Using Text Messages to Boost COVID-19 Vaccine Booking Rate</brief_title>
    <official_title>Using Text Messages to Boost COVID-19 Vaccination Appointment Booking and Vaccination Rates: A Randomised Controlled Field Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Behavioural Insights Team</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Public Health England</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Department of Health and Social Care</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>NHS England and NHS Improvement</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The Behavioural Insights Team</source>
    <oversight_info>
      <has_dmc>No</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>
        This study is a nationwide randomised controlled trial (RCT) to test the impact of&#xD;
        behavioural science-informed text messages notifying patients of their eligibility for the&#xD;
        COVID-19 vaccine on vaccination rates.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 26, 2021</start_date>
    <completion_date type="Actual">May 10, 2021</completion_date>
    <primary_completion_date type="Actual">April 29, 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>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Booking rate within 72 hours</measure>
      <time_frame>72 hours</time_frame>
      <description>The proportion of first dose vaccination appointments booked through the NHS National Booking System within 72 hours (inclusive) of the text message being sent</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Vaccination rate within 14 days</measure>
      <time_frame>14 days</time_frame>
      <description>The proportion of first dose vaccinations received within 14 days (inclusive) of the text message being sent</description>
    </secondary_outcome>
    <number_of_arms>8</number_of_arms>
    <enrollment type="Actual">1825937</enrollment>
    <condition>Vaccination Hesitancy</condition>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Received the text message &quot;You are now eligible for your free NHS Covid-19 vaccine. Please book yours now at [LINK] or by calling 119.&quot;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Simple</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Received the text message &quot;You can now book your free NHS Covid-19 vaccine. Please book yours now at [LINK] or by calling 119.&quot;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Reserved</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Received the text message &quot;Your free NHS Covid-19 vaccine is waiting for you. Please book yours now at [LINK] or by calling 119.&quot;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Top of queue</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Received the text message &quot;You've reached the top of the queue and are a priority for getting a free NHS Covid-19 vaccine. Please book yours now at [LINK] or by calling 119.&quot;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Join the millions</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Received the text message &quot;You are now eligible for your free NHS Covid-19 vaccine. Join the millions who have already had theirs. Please book yours now at [LINK] or by calling 119.&quot;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Convenience</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Received the text message &quot;You are now eligible for your free NHS Covid-19 vaccine. Choose a time and place that suits you. Please book yours now at [LINK] or by calling 119.&quot;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Protection against virus</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Received the text message &quot;You are now eligible for your free NHS Covid-19 vaccine. Getting vaccinated is the best protection against coronavirus. Please book yours now at [LINK] or by calling 119.&quot;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Protect you and those close to you</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Received the text message &quot;You are now eligible for your free NHS Covid-19 vaccine. Getting the vaccine is the best way to protect yourself and those close to you against coronavirus. Please book yours now at [LINK] or by calling 119.&quot;</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioural science-informed text messages</intervention_name>
      <description>Behaviourally-informed content in vaccination eligibility reminder text messages</description>
      <arm_group_label>Convenience</arm_group_label>
      <arm_group_label>Join the millions</arm_group_label>
      <arm_group_label>Protect you and those close to you</arm_group_label>
      <arm_group_label>Protection against virus</arm_group_label>
      <arm_group_label>Reserved</arm_group_label>
      <arm_group_label>Simple</arm_group_label>
      <arm_group_label>Top of queue</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>Control vaccination eligibility reminder text message</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (i) satisfying the age criteria as defined above;&#xD;
  &#xD;
            -  (ii) recorded in the National Immunisation Management System (NIMS);&#xD;
  &#xD;
            -  (iii) with a valid mobile phone number;&#xD;
  &#xD;
            -  (iv) who had not already received or been invited for the COVID-19 vaccine via NIMS at&#xD;
               the time of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants with invalid phone numbers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>44 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hannah Behrendt, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Behavioural Insights Team</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>NHS England</name>
        <address>
          <city>London</city>
          <zip>SE1 8UG</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Behavioural Insights Team</investigator_affiliation>
      <investigator_full_name>Hannah Behrendt</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All data requests should be submitted to NHS England and NHS Improvement (the data controller) for consideration. Access to the raw anonymised data may be granted for non-commercial research at the discretion of NHS England and NHS Improvement. Further information can be obtained from the corresponding author at hannah.behrendt@bi.team.&#xD;
  Custom code that supports the findings of this study is available from the corresponding author upon request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993260
  org study id: 2021035
  nct id: NCT05993260
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a nationwide randomised controlled trial (RCT) to test the impact of
        behavioural science-informed text messages notifying patients of their eligibility for the
        COVID-19 vaccine on vaccination rates.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Care Provider)
  measure: Booking rate within 72 hours
  time frame: 72 hours
  description: The proportion of first dose vaccination appointments booked through the NHS National Booking System within 72 hours (inclusive) of the text message being sent
  measure: Vaccination rate within 14 days
  time frame: 14 days
  description: The proportion of first dose vaccinations received within 14 days (inclusive) of the text message being sent
  arm group label: Control
  arm group type: Active Comparator
  description: Received the text message "You are now eligible for your free NHS Covid-19 vaccine. Please book yours now at [LINK] or by calling 119."
  arm group label: Simple
  arm group type: Experimental
  description: Received the text message "You can now book your free NHS Covid-19 vaccine. Please book yours now at [LINK] or by calling 119."
  arm group label: Reserved
  arm group type: Experimental
  description: Received the text message "Your free NHS Covid-19 vaccine is waiting for you. Please book yours now at [LINK] or by calling 119."
  arm group label: Top of queue
  arm group type: Experimental
  description: Received the text message "You've reached the top of the queue and are a priority for getting a free NHS Covid-19 vaccine. Please book yours now at [LINK] or by calling 119."
  arm group label: Join the millions
  arm group type: Experimental
  description: Received the text message "You are now eligible for your free NHS Covid-19 vaccine. Join the millions who have already had theirs. Please book yours now at [LINK] or by calling 119."
  arm group label: Convenience
  arm group type: Experimental
  description: Received the text message "You are now eligible for your free NHS Covid-19 vaccine. Choose a time and place that suits you. Please book yours now at [LINK] or by calling 119."
  arm group label: Protection against virus
  arm group type: Experimental
  description: Received the text message "You are now eligible for your free NHS Covid-19 vaccine. Getting vaccinated is the best protection against coronavirus. Please book yours now at [LINK] or by calling 119."
  arm group label: Protect you and those close to you
  arm group type: Experimental
  description: Received the text message "You are now eligible for your free NHS Covid-19 vaccine. Getting the vaccine is the best way to protect yourself and those close to you against coronavirus. Please book yours now at [LINK] or by calling 119."
  intervention type: Behavioral
  intervention name: Behavioural science-informed text messages
  description: Behaviourally-informed content in vaccination eligibility reminder text messages
  arm group label: Convenience
  arm group label: Join the millions
  arm group label: Protect you and those close to you
  arm group label: Protection against virus
  arm group label: Reserved
  arm group label: Simple
  arm group label: Top of queue
  intervention type: Behavioral
  intervention name: Control
  description: Control vaccination eligibility reminder text message
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 44 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hannah Behrendt, PhD
  role: Principal Investigator
  affiliation: The Behavioural Insights Team
  facility: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: The Behavioural Insights Team
  investigator full name: Hannah Behrendt
  investigator title: Director
  mesh term: COVID-19
  sharing ipd: Yes
  ipd description: All data requests should be submitted to NHS England and NHS Improvement (the data controller) for consideration. Access to the raw anonymised data may be granted for non-commercial research at the discretion of NHS England and NHS Improvement. Further information can be obtained from the corresponding author at hannah.behrendt@bi.team.
  Custom code that supports the findings of this study is available from the corresponding author upon request.
  ipd info type: Study Protocol
  ipd info type: Analytic Code