<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/NCT03804814</url>
  </required_header>
  <id_info>
    <org_study_id>SAIL-003</org_study_id>
    <nct_id>NCT03804814</nct_id>
  </id_info>
  <brief_title>Motivational Interviewing for HCV Elimination</brief_title>
  <official_title>Assessing a Model for Hepatitis C Elimination: Measuring Patient and Health System Outcomes After Motivational Interviewing Interventions to Increase Treatment Engagement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</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>
      This study addresses a difficult barrier to hepatitis C elimination, specifically development&#xD;
      and maintenance of a productive relationship between the health care provider and patient to&#xD;
      ensure both treatment success and engagement in harm reduction services. Improvements in&#xD;
      these domains may be observed through the use of a technique called &quot;Motivational&#xD;
      Interviewing&quot; (MI). The aim of this study is to determine whether a customized motivational&#xD;
      interviewing curriculum by general primary care and addictions medicine primary care&#xD;
      providers changes rates of curative hepatitis C therapy completion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Pandemic impacted ability to recruit and enroll&#xD;
  </why_stopped>
  <start_date type="Actual">May 21, 2019</start_date>
  <completion_date type="Actual">October 4, 2021</completion_date>
  <primary_completion_date type="Actual">October 4, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HCV Treatment Completion</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>To measure the number of patients who complete HCV therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from care engagement to treatment initiation</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of unique Hepatitis C related and unrelated health system visits</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of scheduled and attended medical care appointments</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported intent to initiate and maintain HCV treatment assessed by questionnaire</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare provider knowledge, attitudes, and behavior about motivational interviewing and training assessed by questionnaire</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to complete prescribed HCV treatment course</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of eligible individuals that initiate HCV therapy</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Motivational Interviewing Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Health care providers will be trained in motivational interviewing for use in Hepatitis C patient encounters.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Clinical Encounter</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Health care providers will not be trained in motivational interviewing for use in Hepatitis C patient encounters.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Interviewing Training</intervention_name>
    <description>Motivational Interviewing is a directive, client-centered counselling style intended to elicit behavior change by helping patients reach health goals through their own desires and actions.&#xD;
A certified and experienced Motivational Interviewing trainer will develop and deliver the curriculum to healthcare providers.</description>
    <arm_group_label>Motivational Interviewing Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Inclusion Criteria:&#xD;
&#xD;
          -  Willingness to participate and provide informed consent&#xD;
&#xD;
          -  Positive HCV RNA Result&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or unable to provide consent&#xD;
&#xD;
        Health Care Provider Inclusion Criteria:&#xD;
&#xD;
          -  Willingness to participate and provide informed consent&#xD;
&#xD;
          -  Has a hepatitis C care experience&#xD;
&#xD;
        Health Care Provider Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or unable to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nova Scotia Health Authority</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dalhousie University</investigator_affiliation>
    <investigator_full_name>Lisa Barrett</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Motivational Interviewing</keyword>
  <keyword>Healthcare delivery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</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/NCT03804814
org study id: SAIL-003
nct id: NCT03804814
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study addresses a difficult barrier to hepatitis C elimination, specifically development
      and maintenance of a productive relationship between the health care provider and patient to
      ensure both treatment success and engagement in harm reduction services. Improvements in
      these domains may be observed through the use of a technique called "Motivational
      Interviewing" (MI). The aim of this study is to determine whether a customized motivational
      interviewing curriculum by general primary care and addictions medicine primary care
      providers changes rates of curative hepatitis C therapy completion.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: HCV Treatment Completion
time frame: Through study completion, an average of 2 years
description: To measure the number of patients who complete HCV therapy
measure: Time from care engagement to treatment initiation
time frame: Through study completion, an average of 2 years
measure: Number of unique Hepatitis C related and unrelated health system visits
time frame: Through study completion, an average of 2 years
measure: Number of scheduled and attended medical care appointments
time frame: Through study completion, an average of 2 years
measure: Self-reported intent to initiate and maintain HCV treatment assessed by questionnaire
time frame: Through study completion, an average of 2 years
measure: Healthcare provider knowledge, attitudes, and behavior about motivational interviewing and training assessed by questionnaire
time frame: Through study completion, an average of 2 years
measure: Time to complete prescribed HCV treatment course
time frame: Through study completion, an average of 2 years
measure: Percentage of eligible individuals that initiate HCV therapy
time frame: Through study completion, an average of 2 years
arm group label: Motivational Interviewing Training
arm group type: Active Comparator
description: Health care providers will be trained in motivational interviewing for use in Hepatitis C patient encounters.
arm group label: Standard Clinical Encounter
arm group type: No Intervention
description: Health care providers will not be trained in motivational interviewing for use in Hepatitis C patient encounters.
intervention type: Behavioral
intervention name: Motivational Interviewing Training
description: Motivational Interviewing is a directive, client-centered counselling style intended to elicit behavior change by helping patients reach health goals through their own desires and actions.
A certified and experienced Motivational Interviewing trainer will develop and deliver the curriculum to healthcare providers.
arm group label: Motivational Interviewing Training
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Dalhousie University
investigator full name: Lisa Barrett
investigator title: Assistant Professor
mesh term: Hepatitis C
mesh term: Hepatitis
sharing ipd: No