<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/NCT03245931</url>
  </required_header>
  <id_info>
    <org_study_id>17007</org_study_id>
    <nct_id>NCT03245931</nct_id>
  </id_info>
  <brief_title>Hepatitis C Education for Pregnant Women With Opiate Addiction - Phase 1</brief_title>
  <official_title>Hepatitis C Education for Pregnant Women With Opiate Addiction - Phase 1</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TriHealth Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TriHealth Inc.</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 study is to assess the health literacy level of patients enrolled in the&#xD;
      HOPE program, identify any gaps in their knowledge of hepatitis C, analyze the variables that&#xD;
      may influence patients' knowledge, and educate patients on Hepatitis C.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will compare the effectiveness of providing a pamphlet and expert education&#xD;
      compared to providing a pamphlet only. The information gained in completing this study will&#xD;
      help the medical community improve patient education on the disease and specifically&#xD;
      understand how the medical community can best serve pregnant patients with opiate dependence&#xD;
      burdened by Hepatitis C.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Actual">August 26, 2019</completion_date>
  <primary_completion_date type="Actual">August 26, 2019</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>Discovering the gaps in patients' knowledge of Hepatitis C</measure>
    <time_frame>2 months</time_frame>
    <description>Through interview, 6 open-ended qualitative questions will be asked of the patients in the HOPE program to assess basic current understanding about Hepatitis C</description>
  </primary_outcome>
  <enrollment type="Actual">8</enrollment>
  <condition>Hepatitis C</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Qualitative Interview</intervention_name>
    <description>Complete 6 open-ended qualitative questions on patients in the HOPE program to assess basic current understanding about Hepatitis C and topics of interest that patients in the HOPE program would like to learn more about.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population includes obstetrics patients enrolled in the HOPE program who are 18 years&#xD;
        old or older.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  The study will include patients with and without Hepatitis C diagnosis.&#xD;
&#xD;
          -  Patients will be recruited at their routine prenatal and post-partum visits.&#xD;
&#xD;
          -  Patients who speak and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of the 18 years&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Michael Marcotte, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TriHealth Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Good Samaritan Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 26, 2019</last_update_submitted>
  <last_update_submitted_qc>August 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</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 C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Opioid-Related Disorders</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/NCT03245931
org study id: 17007
nct id: NCT03245931
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to assess the health literacy level of patients enrolled in the
      HOPE program, identify any gaps in their knowledge of hepatitis C, analyze the variables that
      may influence patients' knowledge, and educate patients on Hepatitis C.
The study will compare the effectiveness of providing a pamphlet and expert education
      compared to providing a pamphlet only. The information gained in completing this study will
      help the medical community improve patient education on the disease and specifically
      understand how the medical community can best serve pregnant patients with opiate dependence
      burdened by Hepatitis C.
observational model: Cohort
time perspective: Prospective
measure: Discovering the gaps in patients' knowledge of Hepatitis C
time frame: 2 months
description: Through interview, 6 open-ended qualitative questions will be asked of the patients in the HOPE program to assess basic current understanding about Hepatitis C
intervention type: Other
intervention name: Qualitative Interview
description: Complete 6 open-ended qualitative questions on patients in the HOPE program to assess basic current understanding about Hepatitis C and topics of interest that patients in the HOPE program would like to learn more about.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Marcotte, MD
role: Principal Investigator
affiliation: TriHealth Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Opioid-Related Disorders
sharing ipd: No