<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/NCT03831555</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00093687</org_study_id>
    <nct_id>NCT03831555</nct_id>
  </id_info>
  <brief_title>Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic</brief_title>
  <official_title>Use of a Psychosocial Readiness Tool to Improve Hepatitis C Treatment Adherence and Outcomes at the Grady Liver Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn more about what psychological and social factors affect&#xD;
      people in how they take their hepatitis C medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to determine if a qualitative survey that assesses a patient's&#xD;
      readiness for treatment of Hepatitis C (HCV) and associated interventions based on identified&#xD;
      barriers can improve treatment adherence and outcomes. HCV remains a leading cause of liver&#xD;
      cancer and end stage liver disease despite greater than 90% cure rates with new, all-oral&#xD;
      antiviral medications. While these new medications are easier to tolerate and access than&#xD;
      previous treatment regimens, medication adherence still remains a great barrier to cure. In&#xD;
      this study, we will administer the Psychosocial Readiness Evaluation and Preparation for&#xD;
      Hepatitis C Treatment (PREP-C) tool, a free, online survey developed at the Mount Sinai&#xD;
      School of Medicine to determine psychosocial readiness for treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants keeping follow-up appointments</measure>
    <time_frame>At 4 months</time_frame>
    <description>Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants keeping follow-up appointments</measure>
    <time_frame>At 8 months</time_frame>
    <description>Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants refilling medications</measure>
    <time_frame>At 4 months</time_frame>
    <description>Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants refilling medications</measure>
    <time_frame>At 8 months</time_frame>
    <description>Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who keep lab visits</measure>
    <time_frame>At 4 months</time_frame>
    <description>Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who keep lab visits</measure>
    <time_frame>At 8 months</time_frame>
    <description>Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rapid virologic response (RVR)</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>The treatment outcome will be measured by analyzing the rapid virologic response (RVR) at 4 weeks after completion of treatment. Rapid virologic response (RVR) is defined as an undetectable serum hepatitis C virus (HCV) RNA. This data will be collected from chart reviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sustained virologic response (SVR)</measure>
    <time_frame>At 12 weeks</time_frame>
    <description>The treatment outcome will be measured by analyzing the sustained virologic response (SVR) at 12 weeks after completion of treatment. SVR is defined as aviremia 12 weeks after completion of antiviral therapy. This data will be collected from chart reviews.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>PREP-C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The research assistant will complete the abbreviated PREP-C survey with the study participants either before or after their medical appointment. The PREP-C tool is accessed online at https://prepc.org/.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive the standard of care (usual care) for chronic HCV infection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PREP-C</intervention_name>
    <description>The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool assesses a patient's psychosocial readiness to start HCV treatment. There are nine sections in the survey:&#xD;
Motivation: reasons client wants to begin HCV treatment, concerns about treatment, and the importance of treatment&#xD;
Information: knowledge about HCV treatment and one's own HCV disease status&#xD;
Medication Adherence: current prescribed medications and adherence to them in the prior month&#xD;
Self-efficacy: self-confidence about adhering to HCV treatment&#xD;
Social Support and Stability: stability of financial, housing, and social support resources&#xD;
Alcohol and substance use: alcohol and substance use behaviors and current treatment&#xD;
Psychiatric Stability: current psychiatric status, previous and current treatment&#xD;
Energy Level: sleep and fatigue&#xD;
Cognitive Functioning: perceived difficulty with communication in health care setting, problem-solving ability, and memory.</description>
    <arm_group_label>PREP-C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  seen in the Grady Liver Clinic during the study time period&#xD;
&#xD;
          -  have a confirmed chronic hepatitis C infection (hepatitis C antibody positive and&#xD;
             detectable hepatitis C viral load)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no chronic hepatitis C infection&#xD;
&#xD;
          -  co-infection with HIV or hepatitis B&#xD;
&#xD;
          -  non-English speaking&#xD;
&#xD;
          -  unable to consent to participate&#xD;
&#xD;
          -  already started HCV therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lesley Miller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grady Liver Clinic</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Lesley Miller</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment tool</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</mesh_term>
  </condition_browse>
  <!-- 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/NCT03831555
org study id: IRB00093687
nct id: NCT03831555
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to learn more about what psychological and social factors affect
      people in how they take their hepatitis C medications.
The goal of this study is to determine if a qualitative survey that assesses a patient's
      readiness for treatment of Hepatitis C (HCV) and associated interventions based on identified
      barriers can improve treatment adherence and outcomes. HCV remains a leading cause of liver
      cancer and end stage liver disease despite greater than 90% cure rates with new, all-oral
      antiviral medications. While these new medications are easier to tolerate and access than
      previous treatment regimens, medication adherence still remains a great barrier to cure. In
      this study, we will administer the Psychosocial Readiness Evaluation and Preparation for
      Hepatitis C Treatment (PREP-C) tool, a free, online survey developed at the Mount Sinai
      School of Medicine to determine psychosocial readiness for treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of participants keeping follow-up appointments
time frame: At 4 months
description: Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews.
measure: Number of participants keeping follow-up appointments
time frame: At 8 months
description: Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews.
measure: Number of participants refilling medications
time frame: At 4 months
description: Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews.
measure: Number of participants refilling medications
time frame: At 8 months
description: Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews.
measure: Number of participants who keep lab visits
time frame: At 4 months
description: Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews.
measure: Number of participants who keep lab visits
time frame: At 8 months
description: Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews.
measure: Rapid virologic response (RVR)
time frame: At 4 weeks
description: The treatment outcome will be measured by analyzing the rapid virologic response (RVR) at 4 weeks after completion of treatment. Rapid virologic response (RVR) is defined as an undetectable serum hepatitis C virus (HCV) RNA. This data will be collected from chart reviews.
measure: Sustained virologic response (SVR)
time frame: At 12 weeks
description: The treatment outcome will be measured by analyzing the sustained virologic response (SVR) at 12 weeks after completion of treatment. SVR is defined as aviremia 12 weeks after completion of antiviral therapy. This data will be collected from chart reviews.
arm group label: PREP-C
arm group type: Active Comparator
description: The research assistant will complete the abbreviated PREP-C survey with the study participants either before or after their medical appointment. The PREP-C tool is accessed online at https://prepc.org/.
arm group label: Standard of care
arm group type: No Intervention
description: Participants will receive the standard of care (usual care) for chronic HCV infection.
intervention type: Behavioral
intervention name: PREP-C
description: The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool assesses a patient's psychosocial readiness to start HCV treatment. There are nine sections in the survey:
Motivation: reasons client wants to begin HCV treatment, concerns about treatment, and the importance of treatment
Information: knowledge about HCV treatment and one's own HCV disease status
Medication Adherence: current prescribed medications and adherence to them in the prior month
Self-efficacy: self-confidence about adhering to HCV treatment
Social Support and Stability: stability of financial, housing, and social support resources
Alcohol and substance use: alcohol and substance use behaviors and current treatment
Psychiatric Stability: current psychiatric status, previous and current treatment
Energy Level: sleep and fatigue
Cognitive Functioning: perceived difficulty with communication in health care setting, problem-solving ability, and memory.
arm group label: PREP-C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lesley Miller, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Lesley Miller
investigator title: Associate Professor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis