<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/NCT03000023</url>
  </required_header>
  <id_info>
    <org_study_id>15-2081</org_study_id>
    <nct_id>NCT03000023</nct_id>
  </id_info>
  <brief_title>Anticipated and Perceived Benefits Following Hepatitis C Treatment</brief_title>
  <official_title>A Qualitative and Quantitative Evaluation of Patients' Anticipated and Perceived Treatment Benefits Following HCV Viral Eradication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is both qualitative and quantitative, gathering patient's perceptions of HCV&#xD;
      treatment benefits before and after HCV treatment by administering surveys and conducting&#xD;
      in-depth qualitative patient interviews. The study seeks to understand all anticipated and&#xD;
      actual benefits patients perceive before and after viral eradication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study employs a mixed methods (qualitative and quantitative) pre-post study design&#xD;
      utilizing in-depth qualitative interviews and patient reported outcome surveys. Pre-treatment&#xD;
      surveys and interviews will be conducted before HCV therapy commences to understand all&#xD;
      potential psychological, social, physical and medical consequences perceived to be related to&#xD;
      HCV and the patients' anticipation (hope for) of improvements in these factors after viral&#xD;
      eradication. Post-treatment surveys and interviews will occur 4 to 8 months after treatment&#xD;
      ends to examine long-term treatment benefits, i.e., changes in HCV-related factors, such as&#xD;
      symptoms, functioning, and health status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</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>Analyze changes in patient perceptions through qualitative interviews before and after HCV treatment.</measure>
    <time_frame>1 Year</time_frame>
    <description>To conduct a pre-post qualitative analysis that will evaluate changes in a broad range of patients' perceptions of psychological, social, and physical effects associated with HCV and viral cure collected through qualitative interviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate pre-post survey change in patient reported HCV symptoms and other factors.</measure>
    <time_frame>1 Year</time_frame>
    <description>To conduct a pre-post survey evaluation of change in patient-reported HCV symptoms, functioning, and health perceptions associated with HCV and viral cure.</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Hepatitis C</condition>
  <condition>Hepatitis C, Chronic</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Hepatitis C&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 or older&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Any genotype&#xD;
&#xD;
          -  Any treatment duration (e.g. 8, 12, or 24 weeks)&#xD;
&#xD;
          -  Has been written a prescription for a sofosbuvir (SOF)-containing regimen.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently listed for liver transplant; post-liver transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donna Evon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>October 22, 2018</last_update_submitted>
  <last_update_submitted_qc>October 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis C</keyword>
  <keyword>Patient-Reported Outcomes</keyword>
  <keyword>DAA Treatment</keyword>
  <keyword>Qualitative</keyword>
  <keyword>Mixed methods</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</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>


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/NCT03000023
org study id: 15-2081
nct id: NCT03000023
lead sponsor: 
collaborator: 
has dmc: No
The study is both qualitative and quantitative, gathering patient's perceptions of HCV
      treatment benefits before and after HCV treatment by administering surveys and conducting
      in-depth qualitative patient interviews. The study seeks to understand all anticipated and
      actual benefits patients perceive before and after viral eradication.
This study employs a mixed methods (qualitative and quantitative) pre-post study design
      utilizing in-depth qualitative interviews and patient reported outcome surveys. Pre-treatment
      surveys and interviews will be conducted before HCV therapy commences to understand all
      potential psychological, social, physical and medical consequences perceived to be related to
      HCV and the patients' anticipation (hope for) of improvements in these factors after viral
      eradication. Post-treatment surveys and interviews will occur 4 to 8 months after treatment
      ends to examine long-term treatment benefits, i.e., changes in HCV-related factors, such as
      symptoms, functioning, and health status.
observational model: Cohort
time perspective: Prospective
measure: Analyze changes in patient perceptions through qualitative interviews before and after HCV treatment.
time frame: 1 Year
description: To conduct a pre-post qualitative analysis that will evaluate changes in a broad range of patients' perceptions of psychological, social, and physical effects associated with HCV and viral cure collected through qualitative interviews.
measure: Evaluate pre-post survey change in patient reported HCV symptoms and other factors.
time frame: 1 Year
description: To conduct a pre-post survey evaluation of change in patient-reported HCV symptoms, functioning, and health perceptions associated with HCV and viral cure.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Donna Evon, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
sharing ipd: No