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/NCT05977192</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-22-282-STW</org_study_id>
      <nct_id>NCT05977192</nct_id>
    </id_info>
    <brief_title>Mobile Health-based Motivational Interviewing to Promote COVID-19 Vaccination</brief_title>
    <acronym>COVID-19</acronym>
    <official_title>Mobile Health-based Motivational Interviewing to Promote Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination in Oklahomans</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oklahoma State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Oklahoma State University</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 objective of this study is to evaluate the preliminary efficacy and acceptability of an&#xD;
        mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2&#xD;
        vaccination (MOTIVACC) compared to traditional phone-based MI.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in vaccine hesitancy and confidence</measure>
      <time_frame>Baseline and follow-up (8 weeks)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in intention to receive the vaccine</measure>
      <time_frame>Baseline and follow-up (8 weeks)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in expectations related to vaccines</measure>
      <time_frame>Baseline and follow-up (8 weeks)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in self-efficacy</measure>
      <time_frame>Baseline and follow-up (8 weeks)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in ambivalence</measure>
      <time_frame>Baseline and follow-up (8 weeks)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in value-behavior discrepancy</measure>
      <time_frame>Baseline and follow-up (8 weeks)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who receive the COVID-19 vaccine</measure>
      <time_frame>Follow-up (8 weeks)</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Percentage of total of ecological momentary assessment messages opened/viewed</measure>
      <time_frame>8 weeks (from baseline to follow up)</time_frame>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Vaccination Hesitancy</condition>
    <arm_group>
      <arm_group_label>Standard MI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Intensive MI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>MOTIVACC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard MI</intervention_name>
      <description>One phone-based MI session</description>
      <arm_group_label>Standard MI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Intensive MI</intervention_name>
      <description>Four phone-based MI sessions</description>
      <arm_group_label>Intensive MI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>MOTIVACC</intervention_name>
      <description>mHealth-based MI</description>
      <arm_group_label>MOTIVACC</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Ecological momentary assessment (EMA) messages</intervention_name>
      <description>EMA messages focused on vaccinations and health</description>
      <arm_group_label>Intensive MI</arm_group_label>
      <arm_group_label>MOTIVACC</arm_group_label>
      <arm_group_label>Standard MI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &gt;18 years&#xD;
  &#xD;
            -  Reside in a rural area&#xD;
  &#xD;
            -  No previous dose of a SARS-CoV-2 vaccine&#xD;
  &#xD;
            -  Speak English&#xD;
  &#xD;
            -  Able to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A cognitive or other disability that inhibits smart phone use&#xD;
  &#xD;
            -  Inability to participate because of medical or psychiatric conditions diagnosed by a&#xD;
               physician/clinician&#xD;
  &#xD;
            -  Enrollment in other COVID-19 research; pregnant or lactating&#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_contact>
      <last_name>Ashlea Braun</last_name>
      <phone>567-240-1582</phone>
      <email>ashlea.braun@okstate.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Thanh Bui</last_name>
      <phone>405-271-8001</phone>
      <phone_ext>50559</phone_ext>
      <email>thanh-c-bui@ouhsc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Oklahoma</name>
        <address>
          <city>Oklahoma City</city>
          <state>Oklahoma</state>
          <zip>73104</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Thanh Bui</last_name>
      </contact>
      <contact_backup>
        <phone>405-271-8001</phone>
        <phone_ext>50559</phone_ext>
        <email>thanh-c-bui@ouhsc.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Thanh Bui</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Oklahoma State University</name>
        <address>
          <city>Stillwater</city>
          <state>Oklahoma</state>
          <zip>74078</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ashlea Braun, PhD</last_name>
        <phone>567-240-1582</phone>
        <email>ashlea.braun@okstate.edu</email>
      </contact>
      <investigator>
        <last_name>Ashlea Braun</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Oklahoma State University</investigator_affiliation>
      <investigator_full_name>ABraun</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <!-- 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/NCT05977192
  org study id: IRB-22-282-STW
  nct id: NCT05977192
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to evaluate the preliminary efficacy and acceptability of an
        mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2
        vaccination (MOTIVACC) compared to traditional phone-based MI.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Changes in vaccine hesitancy and confidence
  time frame: Baseline and follow-up (8 weeks)
  measure: Changes in intention to receive the vaccine
  time frame: Baseline and follow-up (8 weeks)
  measure: Changes in expectations related to vaccines
  time frame: Baseline and follow-up (8 weeks)
  measure: Changes in self-efficacy
  time frame: Baseline and follow-up (8 weeks)
  measure: Changes in ambivalence
  time frame: Baseline and follow-up (8 weeks)
  measure: Changes in value-behavior discrepancy
  time frame: Baseline and follow-up (8 weeks)
  measure: Number of participants who receive the COVID-19 vaccine
  time frame: Follow-up (8 weeks)
  measure: Percentage of total of ecological momentary assessment messages opened/viewed
  time frame: 8 weeks (from baseline to follow up)
  arm group label: Standard MI
  arm group type: Experimental
  arm group label: Intensive MI
  arm group type: Experimental
  arm group label: MOTIVACC
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Standard MI
  description: One phone-based MI session
  arm group label: Standard MI
  intervention type: Behavioral
  intervention name: Intensive MI
  description: Four phone-based MI sessions
  arm group label: Intensive MI
  intervention type: Behavioral
  intervention name: MOTIVACC
  description: mHealth-based MI
  arm group label: MOTIVACC
  intervention type: Behavioral
  intervention name: Ecological momentary assessment (EMA) messages
  description: EMA messages focused on vaccinations and health
  arm group label: Intensive MI
  arm group label: MOTIVACC
  arm group label: Standard MI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ashlea Braun
  phone: 567-240-1582
  email: ashlea.braun@okstate.edu
  last name: Thanh Bui
  phone: 405-271-8001
  phone ext: 50559
  email: thanh-c-bui@ouhsc.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Oklahoma State University
  investigator full name: ABraun
  investigator title: Assistant Professor