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/NCT05998824</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00110966</org_study_id>
      <nct_id>NCT05998824</nct_id>
    </id_info>
    <brief_title>COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease</brief_title>
    <official_title>COVID-19 Vaccination Hesitancy in Adults With Sickle Cell Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Society of Hematology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke 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 goal of this clinical trial is to test an COVID-19 vaccination information video in&#xD;
        adults with sickle cell disease. The main questions it aims to answer are why are some adults&#xD;
        with sickle cell disease hesitant to receive COVID-19 vaccination and whether a COVID-19&#xD;
        vaccination information video tailored for people with sickle cell disease will reduce&#xD;
        vaccine hesitancy. Participants will complete a brief survey before and after watching a&#xD;
        short video with information on vaccine safety, efficacy, and the greater impact of COVID-19&#xD;
        infection on people with sickle cell disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this research study, we seek to gain a better understanding of reasons for COVID-19&#xD;
        vaccine hesitancy in adults with sickle cell disease (SCD). We will develop a SCD-specific&#xD;
        COVID-19 vaccination information (SCVI) video that discusses vaccine safety, efficacy, and&#xD;
        necessity of COVID-19 vaccination for the sickle cell patient population, and determine if&#xD;
        the video reduces vaccine hesitancy in adults with SCD. Hopefully, this will inform future&#xD;
        education interventions to improve confidence in COVID-19 vaccines and subsequently increase&#xD;
        vaccination rates.&#xD;
  &#xD;
        Specifically, the research objectives are:&#xD;
  &#xD;
        To determine factors associated with COVID-19 vaccine hesitancy in adults with SCD To&#xD;
        determine if a SCD-specific COVID-19 vaccination information (SCVI) video reduces vaccine&#xD;
        hesitancy in adults with SCD.&#xD;
  &#xD;
        This study will be conducted as a part of an ongoing prospective research study aimed at&#xD;
        better understanding COVID-19 vaccine hesitancy at the Duke Adult Comprehensive Sickle Cell&#xD;
        Center. Two cross-sectional surveys will be administered to patients seen in the Adult Sickle&#xD;
        Cell Clinic and Day Hospital who meet the inclusion criteria. The purpose of the initial&#xD;
        survey will be to obtain a baseline vaccination rate and to gain a better understanding&#xD;
        behind vaccine hesitancy in this patient population. After completion of the first survey, a&#xD;
        short video discussing the safety, efficacy, and importance of the COVID-19 vaccine for&#xD;
        patients with sickle cell disease will be watched prior to completing the second survey. The&#xD;
        video will be available via scanning a QR code or via direct link if the survey is filled out&#xD;
        electronically. Members of the Community Advisory Board for the Duke Sickle Cell Program will&#xD;
        be interviewed in a group to gain an understanding of how to improve and implement the&#xD;
        assessment in practice (non-research activity). A subsequent &quot;post-intervention&quot; survey will&#xD;
        then administered to determine if the SCVI video reduces vaccine hesitancy in adults with&#xD;
        SCD. Both surveys should take ~5 minutes to complete. We estimate that these surveys will&#xD;
        reach ~250 patients over the six months they are administered. Informed consent will obtained&#xD;
        prior to completion of the surveys and watching the video. Survey responses will remain&#xD;
        anonymous with no patient identifying information required for completion. Data will be&#xD;
        stored and protected using the secure REDCap database.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 23, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>measurement by survey before and after intervention</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Vaccine hesitancy</measure>
      <time_frame>before and after watching video</time_frame>
      <description>To assess vaccine hesitancy in patients not vaccinated for COVID-19, we will ask participants &quot;how likely are you to get vaccinated for COVID-19 in the future?&quot;. Response options will be dichotomized into not hesitant (&quot;likely or somewhat likely&quot;) vs neutral vs hesitant (&quot;somewhat unlikely or not likely&quot;). We will also assess vaccine hesitancy for people</description>
    </primary_outcome>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Sickle Cell Disease</condition>
    <condition>COVID-19 Vaccine</condition>
    <condition>Vaccine Hesitancy</condition>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SCD-specific COVID-19 vaccination information (SCVI) video</intervention_name>
      <description>SCD-specific COVID-19 vaccination information (SCVI) video developed by health care providers with input from a community advisory board of people with sickle cel disease and their caregivers.</description>
      <other_name>Video</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of sickle cell disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unable to read or understand spoken English to complete the survey&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>John Strouse, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ashley Thrower, MD</last_name>
      <phone>919-684-0628</phone>
      <email>ashley.thrower@duke.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>John Strouse, MD, PhD</last_name>
      <phone>919-684-0628</phone>
      <email>john.strouse@duke.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Duke Adult Sickle Cell Program</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ashley Thrower, MD</last_name>
        <phone>919-684-0628</phone>
        <email>ashley.thrower@duke.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Duke University</investigator_affiliation>
      <investigator_full_name>John J. Strouse, M.D., Ph.D.</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Anemia, Sickle Cell</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05998824
  org study id: Pro00110966
  nct id: NCT05998824
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test an COVID-19 vaccination information video in
        adults with sickle cell disease. The main questions it aims to answer are why are some adults
        with sickle cell disease hesitant to receive COVID-19 vaccination and whether a COVID-19
        vaccination information video tailored for people with sickle cell disease will reduce
        vaccine hesitancy. Participants will complete a brief survey before and after watching a
        short video with information on vaccine safety, efficacy, and the greater impact of COVID-19
        infection on people with sickle cell disease.
  In this research study, we seek to gain a better understanding of reasons for COVID-19
        vaccine hesitancy in adults with sickle cell disease (SCD). We will develop a SCD-specific
        COVID-19 vaccination information (SCVI) video that discusses vaccine safety, efficacy, and
        necessity of COVID-19 vaccination for the sickle cell patient population, and determine if
        the video reduces vaccine hesitancy in adults with SCD. Hopefully, this will inform future
        education interventions to improve confidence in COVID-19 vaccines and subsequently increase
        vaccination rates.
  
        Specifically, the research objectives are:
  
        To determine factors associated with COVID-19 vaccine hesitancy in adults with SCD To
        determine if a SCD-specific COVID-19 vaccination information (SCVI) video reduces vaccine
        hesitancy in adults with SCD.
  
        This study will be conducted as a part of an ongoing prospective research study aimed at
        better understanding COVID-19 vaccine hesitancy at the Duke Adult Comprehensive Sickle Cell
        Center. Two cross-sectional surveys will be administered to patients seen in the Adult Sickle
        Cell Clinic and Day Hospital who meet the inclusion criteria. The purpose of the initial
        survey will be to obtain a baseline vaccination rate and to gain a better understanding
        behind vaccine hesitancy in this patient population. After completion of the first survey, a
        short video discussing the safety, efficacy, and importance of the COVID-19 vaccine for
        patients with sickle cell disease will be watched prior to completing the second survey. The
        video will be available via scanning a QR code or via direct link if the survey is filled out
        electronically. Members of the Community Advisory Board for the Duke Sickle Cell Program will
        be interviewed in a group to gain an understanding of how to improve and implement the
        assessment in practice (non-research activity). A subsequent "post-intervention" survey will
        then administered to determine if the SCVI video reduces vaccine hesitancy in adults with
        SCD. Both surveys should take ~5 minutes to complete. We estimate that these surveys will
        reach ~250 patients over the six months they are administered. Informed consent will obtained
        prior to completion of the surveys and watching the video. Survey responses will remain
        anonymous with no patient identifying information required for completion. Data will be
        stored and protected using the secure REDCap database.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: measurement by survey before and after intervention
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Vaccine hesitancy
  time frame: before and after watching video
  description: To assess vaccine hesitancy in patients not vaccinated for COVID-19, we will ask participants "how likely are you to get vaccinated for COVID-19 in the future?". Response options will be dichotomized into not hesitant ("likely or somewhat likely") vs neutral vs hesitant ("somewhat unlikely or not likely"). We will also assess vaccine hesitancy for people
  intervention type: Behavioral
  intervention name: SCD-specific COVID-19 vaccination information (SCVI) video
  description: SCD-specific COVID-19 vaccination information (SCVI) video developed by health care providers with input from a community advisory board of people with sickle cel disease and their caregivers.
  other name: Video
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: John Strouse, MD, PhD
  role: Principal Investigator
  affiliation: Duke University
  last name: Ashley Thrower, MD
  phone: 919-684-0628
  email: ashley.thrower@duke.edu
  last name: John Strouse, MD, PhD
  phone: 919-684-0628
  email: john.strouse@duke.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Duke University
  investigator full name: John J. Strouse, M.D., Ph.D.
  investigator title: Associate Professor
  mesh term: COVID-19
  mesh term: Anemia, Sickle Cell
  sharing ipd: No