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/NCT06017375</url>
    </required_header>
    <id_info>
      <org_study_id>330645</org_study_id>
      <nct_id>NCT06017375</nct_id>
    </id_info>
    <brief_title>Patient Knowledge, Beliefs and Barriers to Hepatitis D Care</brief_title>
    <official_title>Patient Knowledge, Beliefs and Barriers to Hepatitis D Care; Single Site Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King's College Hospital NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>King's College Hospital NHS Trust</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>
        A project to understand the determinants of health behaviour among those with chronic&#xD;
        hepatitis D virus (HDV) infection, under the care of the viral hepatitis service at Kings&#xD;
        College Hospital (KCH). This is to improve and implement pathways and patient information&#xD;
        distribution to improve access to care in an ethnically diverse population living with HDV in&#xD;
        the UK.&#xD;
  &#xD;
        Kings college hospital NHS Foundation Trust is uniquely placed and serves a large diverse&#xD;
        population from areas such as pan pacific Asia, Eastern Europe and regions in Africa, where&#xD;
        English is not their first language. This diversity is also seen in other London Hospitals&#xD;
        but less so in other parts of the UK.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To understand the knowledge patients have around their diagnosis of hepatitis D which is&#xD;
        considered a rare disease but the most aggressive form of viral hepatitis. In order to&#xD;
        improve the management of hepatitis D, this research aims to identify the current knowledge&#xD;
        patients have about their diagnosis, the information provided to them in their preferred&#xD;
        language, how they feel about their diagnosis and the stigma attached. This research has been&#xD;
        conducted in patients with other forms of viral hepatitis but not in patients living with&#xD;
        hepatitis D. There is a lack of research in this area. With this research we aim to improve&#xD;
        treatment pathways, access to care and to information.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The overall patient understanding of Hepatitis D Virus diagnosis</measure>
      <time_frame>6 months</time_frame>
      <description>Use of modified CLDQ - HBV survey. Scale of 1-7 with lower scores indicating worse outcomes</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Describe overall patient knowledge around HDV</measure>
      <time_frame>6 months</time_frame>
      <description>Modified HBV knowledge scale survey. Yes or No as options</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Describe stigma attached towards HDV</measure>
      <time_frame>6 months</time_frame>
      <description>Use of modified Toronto HBV stigma questionnaire. Scale options are: never, rarely, sometimes, often, always</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Understand satisfaction with communication regarding HDV care at KCH</measure>
      <time_frame>6 months</time_frame>
      <description>Use of local viral hepatitis service questionnaire</description>
    </secondary_outcome>
    <enrollment type="Anticipated">113</enrollment>
    <condition>Hepatitis, Delta</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire based intervention</intervention_name>
      <description>Three validated questionnaires amended from hepatitis B to D (Chronic liver disease questionnaire, self-stigma scale and HBV virus knowledge scale) will be used.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with past or current hepatitis D virus infection&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants 18 years or older.&#xD;
  &#xD;
            -  HDV infection as diagnosed by high levels of anti-HDV immunoglobulin G (IgG) and&#xD;
               immunoglobulin M (IgM), and confirmed by detection of HDV RNA in serum.&#xD;
  &#xD;
            -  Treated HDV infection&#xD;
  &#xD;
            -  Willing and able to provide written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Clinically significant medical or psychiatric illness in the past, present, or being&#xD;
               evaluated, that may interfere with participant treatment, safety and assessment.&#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>Sital Shah</last_name>
      <phone>02032999000</phone>
      <phone_ext>35714</phone_ext>
      <email>sitalshah@nhs.net</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hepatitis A</mesh_term>
      <mesh_term>Hepatitis D</mesh_term>
      <mesh_term>Hepatitis</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/NCT06017375
  org study id: 330645
  nct id: NCT06017375
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A project to understand the determinants of health behaviour among those with chronic
        hepatitis D virus (HDV) infection, under the care of the viral hepatitis service at Kings
        College Hospital (KCH). This is to improve and implement pathways and patient information
        distribution to improve access to care in an ethnically diverse population living with HDV in
        the UK.
  
        Kings college hospital NHS Foundation Trust is uniquely placed and serves a large diverse
        population from areas such as pan pacific Asia, Eastern Europe and regions in Africa, where
        English is not their first language. This diversity is also seen in other London Hospitals
        but less so in other parts of the UK.
  To understand the knowledge patients have around their diagnosis of hepatitis D which is
        considered a rare disease but the most aggressive form of viral hepatitis. In order to
        improve the management of hepatitis D, this research aims to identify the current knowledge
        patients have about their diagnosis, the information provided to them in their preferred
        language, how they feel about their diagnosis and the stigma attached. This research has been
        conducted in patients with other forms of viral hepatitis but not in patients living with
        hepatitis D. There is a lack of research in this area. With this research we aim to improve
        treatment pathways, access to care and to information.
  observational model: Cohort
  time perspective: Prospective
  measure: The overall patient understanding of Hepatitis D Virus diagnosis
  time frame: 6 months
  description: Use of modified CLDQ - HBV survey. Scale of 1-7 with lower scores indicating worse outcomes
  measure: Describe overall patient knowledge around HDV
  time frame: 6 months
  description: Modified HBV knowledge scale survey. Yes or No as options
  measure: Describe stigma attached towards HDV
  time frame: 6 months
  description: Use of modified Toronto HBV stigma questionnaire. Scale options are: never, rarely, sometimes, often, always
  measure: Understand satisfaction with communication regarding HDV care at KCH
  time frame: 6 months
  description: Use of local viral hepatitis service questionnaire
  intervention type: Other
  intervention name: Questionnaire based intervention
  description: Three validated questionnaires amended from hepatitis B to D (Chronic liver disease questionnaire, self-stigma scale and HBV virus knowledge scale) will be used.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sital Shah
  phone: 02032999000
  phone ext: 35714
  email: sitalshah@nhs.net
  responsible party type: Sponsor
  mesh term: Hepatitis A
  mesh term: Hepatitis D
  mesh term: Hepatitis
  sharing ipd: No