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/NCT05994820</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00023512</org_study_id>
      <nct_id>NCT05994820</nct_id>
    </id_info>
    <brief_title>Chatbot-based Intervention to Promote Vaccine Acceptance in Varansi, India</brief_title>
    <official_title>Implementing and Evaluating a Chatbot-based Intervention to Promote Vaccine Acceptance in Varansi, India</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins Bloomberg School of Public Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Johns Hopkins Bloomberg School of Public Health</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>
        The goal of this clinical trial is to learn compare the efficacy Chatbot messaging directed&#xD;
        to parents of infants and children living in unstable urban housing (UUH) in Varansi, India.&#xD;
        The main questions it aims to answer are: 1) Can a Chatbot intervention be used to improve&#xD;
        attitudes towards childhood vaccines? 2) Does an intervention in which vaccination is&#xD;
        presented in the larger context of well-being improve attitudes towards vaccination?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Only 2/3 of Indian infants and children are fully immunized. In communities facing unstable&#xD;
        urban housing (UUH) vaccination rates are even lower. COVID-19 introduced new challenges for&#xD;
        community health workers in these areas, and many do not have the capacity to promote&#xD;
        vaccination. At the same time, the pandemic also prompted more parents and caregivers to&#xD;
        engage with smartphones to manage the child's health. The investigators believe that a&#xD;
        WhatsApp-based Chatbot intervention may be an effective way to promote routine childhood&#xD;
        vaccination among caregivers without creating additional burdens on community health workers.&#xD;
        To test this, the investigators are developing the Happy Baby Programme. This programme will&#xD;
        be disseminated as a Chatbot through WhatsApp to parents of infants and young children living&#xD;
        in Varanasi, in the Indian state of Uttar Pradesh. In addition to testing the overall&#xD;
        efficacy of a Chatbot messaging platform, the investigators will compare two different&#xD;
        Chatbot messaging designs, one featuring vaccine-only messaging and a second that positions&#xD;
        vaccines as part of a broader set of well-being practices.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>All parties are aware of assignment</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Post Intervention Vaccine Intentions</measure>
      <time_frame>4 months</time_frame>
      <description>Vaccine intentions will be assessed through 3-Likert type questions that ask participants to respond on a five-point scale (from strongly disagree to strongly agree, where higher scores mean more higher intentions). Responses will be averaged into an index (spanning from 0 = lowest intention to 5 = highest intention to vaccinate) to signify vaccine intentions. We will assess changes in these intentions from baseline to post-intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Post Intervention Vaccine Attitudes</measure>
      <time_frame>4 months</time_frame>
      <description>Vaccine attitudes will be assessed through an 8-item scale using Likert-style questions that ask participants to respond on a five-point scale (from strongly disagree to strongly agree, where higher scores mean more positive agreement). Responses will be averaged into an index (spanning from 0 = lowest intention to 5 = highest intention to vaccinate) to signify vaccine attitudes. We will assess changes in these attitudes from baseline to post-intervention. Please note that, in this methodology, there is no need to create a binary &quot;negative attitude&quot; versus &quot;positive attitude.&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Post Intervention Vaccine Hesitancy</measure>
      <time_frame>4 months</time_frame>
      <description>Vaccine Hesitancy will be assessed through a validated 10-item scale from Shapiro et al. 2017. All items utilize a Likert-type response format. that ask participants to respond on a five-point scale (from strongly disagree to strongly agree, where higher scores mean more positive agreement) answers. Responses will be averaged into an index (spanning from 0 = most hesitancy, to 5 = least least hesitancy) to signify vaccine hesitancy. We will assess changes in hesitancy from baseline to post-intervention. Please note that, in this methodology, there is no need to create a binary &quot;hesitant&quot; versus &quot;not hesitant.&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Parental Awareness of Vaccine Services</measure>
      <time_frame>4 months</time_frame>
      <description>Awareness will be assessed through 2 knowledge based questions on a questionnaire administered after the intervention. Responses will scored on a three-point scale: 0 = not aware; 1 = aware but does not know the date; and 2= aware and knows the date. Higher scores correspond to greater awareness.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">1950</enrollment>
    <condition>Vaccine Hesitancy</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>These participants receive no intervention. No chatbot messaging. Usual care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Vaccine Campaign</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>These participants will receive the Happy Baby Programme messages through a WhatsApp Chatbot. All messages will be narrowly focused on vaccine promotion.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Vaccine++ Campaign</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>These participants will receive the Happy Baby Programme messages through a WhatsApp Chatbot. All messages will promote vaccines in conjunction with other health-promotion activities (e.g. nutrition, breastfeeding, etc.).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Happy Baby Programme -Vaccine Campaign</intervention_name>
      <description>The Happy Baby Programme is a WhatsApp based Chatbot designed to promote childhood vaccination in Hindi.</description>
      <arm_group_label>Vaccine Campaign</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Happy Baby Programme- Vaccine ++ Campaign</intervention_name>
      <description>The Happy Baby Programme is a WhatsApp based Chatbot designed to promote childhood vaccination in Hindi as part of a holistic healthy baby approach that includes nutrition and sanitation.</description>
      <arm_group_label>Vaccine++ Campaign</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Speak Hindi;&#xD;
  &#xD;
            -  Reside in selected UUH neighborhood of Varanasi, India;&#xD;
  &#xD;
            -  Identify as a caregiver of a young child (&lt;2) OR be at least 5 months pregnant and due&#xD;
               to giver birth during the study period;&#xD;
  &#xD;
            -  Child is registered with local community health workers and included on patient&#xD;
               rosters for vaccination clinics (also known as Village Health Sanitation and Nutrition&#xD;
               Days (VHSNDs));&#xD;
  &#xD;
            -  Have regular access to a phone with WhatsApp.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Only one caregiver is eligible per household&#xD;
  &#xD;
            -  Not meeting inclusion criteria.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rajiv N Rimal, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rajiv N Rimal, PhD</last_name>
      <phone>4104916139</phone>
      <email>rimal@jhu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amelia M Jamison, MPH</last_name>
      <phone>2028735557</phone>
      <email>ajamiso5@jh.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>D-COR (Development Corner) Consulting</name>
        <address>
          <city>Dwārka</city>
          <state>New Delhi</state>
          <zip>110077</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Satyanarayan Mohanty, MA</last_name>
        <phone>+91 99375-04610</phone>
        <email>satya@dcor.com</email>
      </contact>
      <investigator>
        <last_name>Satyanarayan Mohanty, MA</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Health Communication</keyword>
    <keyword>Chatbot</keyword>
    <keyword>Social Networks</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>All participant data will be deidentified and stored on local servers (in India). American researchers will only access deidentified data for evaluation purposes.</ipd_description>
    </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/NCT05994820
  org study id: IRB00023512
  nct id: NCT05994820
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn compare the efficacy Chatbot messaging directed
        to parents of infants and children living in unstable urban housing (UUH) in Varansi, India.
        The main questions it aims to answer are: 1) Can a Chatbot intervention be used to improve
        attitudes towards childhood vaccines? 2) Does an intervention in which vaccination is
        presented in the larger context of well-being improve attitudes towards vaccination?
  Only 2/3 of Indian infants and children are fully immunized. In communities facing unstable
        urban housing (UUH) vaccination rates are even lower. COVID-19 introduced new challenges for
        community health workers in these areas, and many do not have the capacity to promote
        vaccination. At the same time, the pandemic also prompted more parents and caregivers to
        engage with smartphones to manage the child's health. The investigators believe that a
        WhatsApp-based Chatbot intervention may be an effective way to promote routine childhood
        vaccination among caregivers without creating additional burdens on community health workers.
        To test this, the investigators are developing the Happy Baby Programme. This programme will
        be disseminated as a Chatbot through WhatsApp to parents of infants and young children living
        in Varanasi, in the Indian state of Uttar Pradesh. In addition to testing the overall
        efficacy of a Chatbot messaging platform, the investigators will compare two different
        Chatbot messaging designs, one featuring vaccine-only messaging and a second that positions
        vaccines as part of a broader set of well-being practices.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  masking description: All parties are aware of assignment
  measure: Post Intervention Vaccine Intentions
  time frame: 4 months
  description: Vaccine intentions will be assessed through 3-Likert type questions that ask participants to respond on a five-point scale (from strongly disagree to strongly agree, where higher scores mean more higher intentions). Responses will be averaged into an index (spanning from 0 = lowest intention to 5 = highest intention to vaccinate) to signify vaccine intentions. We will assess changes in these intentions from baseline to post-intervention.
  measure: Post Intervention Vaccine Attitudes
  time frame: 4 months
  description: Vaccine attitudes will be assessed through an 8-item scale using Likert-style questions that ask participants to respond on a five-point scale (from strongly disagree to strongly agree, where higher scores mean more positive agreement). Responses will be averaged into an index (spanning from 0 = lowest intention to 5 = highest intention to vaccinate) to signify vaccine attitudes. We will assess changes in these attitudes from baseline to post-intervention. Please note that, in this methodology, there is no need to create a binary "negative attitude" versus "positive attitude."
  measure: Post Intervention Vaccine Hesitancy
  time frame: 4 months
  description: Vaccine Hesitancy will be assessed through a validated 10-item scale from Shapiro et al. 2017. All items utilize a Likert-type response format. that ask participants to respond on a five-point scale (from strongly disagree to strongly agree, where higher scores mean more positive agreement) answers. Responses will be averaged into an index (spanning from 0 = most hesitancy, to 5 = least least hesitancy) to signify vaccine hesitancy. We will assess changes in hesitancy from baseline to post-intervention. Please note that, in this methodology, there is no need to create a binary "hesitant" versus "not hesitant."
  measure: Parental Awareness of Vaccine Services
  time frame: 4 months
  description: Awareness will be assessed through 2 knowledge based questions on a questionnaire administered after the intervention. Responses will scored on a three-point scale: 0 = not aware; 1 = aware but does not know the date; and 2= aware and knows the date. Higher scores correspond to greater awareness.
  arm group label: Control
  arm group type: No Intervention
  description: These participants receive no intervention. No chatbot messaging. Usual care.
  arm group label: Vaccine Campaign
  arm group type: Experimental
  description: These participants will receive the Happy Baby Programme messages through a WhatsApp Chatbot. All messages will be narrowly focused on vaccine promotion.
  arm group label: Vaccine++ Campaign
  arm group type: Experimental
  description: These participants will receive the Happy Baby Programme messages through a WhatsApp Chatbot. All messages will promote vaccines in conjunction with other health-promotion activities (e.g. nutrition, breastfeeding, etc.).
  intervention type: Behavioral
  intervention name: Happy Baby Programme -Vaccine Campaign
  description: The Happy Baby Programme is a WhatsApp based Chatbot designed to promote childhood vaccination in Hindi.
  arm group label: Vaccine Campaign
  intervention type: Behavioral
  intervention name: Happy Baby Programme- Vaccine ++ Campaign
  description: The Happy Baby Programme is a WhatsApp based Chatbot designed to promote childhood vaccination in Hindi as part of a holistic healthy baby approach that includes nutrition and sanitation.
  arm group label: Vaccine++ Campaign
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rajiv N Rimal, PhD
  role: Principal Investigator
  affiliation: Johns Hopkins University
  last name: Rajiv N Rimal, PhD
  phone: 4104916139
  email: rimal@jhu.edu
  last name: Amelia M Jamison, MPH
  phone: 2028735557
  email: ajamiso5@jh.edu
  facility: 
  contact: 
  investigator: 
  country: India
  responsible party type: Sponsor
  mesh term: Vaccines
  sharing ipd: No
  ipd description: All participant data will be deidentified and stored on local servers (in India). American researchers will only access deidentified data for evaluation purposes.