<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/NCT03776760</url>
  </required_header>
  <id_info>
    <org_study_id>VHCRP1802</org_study_id>
    <nct_id>NCT03776760</nct_id>
  </id_info>
  <brief_title>Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination</brief_title>
  <acronym>SCALE-C</acronym>
  <official_title>Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kirby Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>South Australian Health and Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Flinders University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kirby Institute</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>
      A community-based &quot;test and treat&quot; intervention integrating point-of-care HCV RNA testing,&#xD;
      non-invasive liver disease assessment and linkage to care will lead to a reduction in HCV&#xD;
      prevalence among people attending Aboriginal health services.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SCALE-C is an interventional cohort study recruiting people with or at risk of HCV infection&#xD;
      from Aboriginal health services in Australia. Participants will be screened for HCV infection&#xD;
      using point-of-care testing (anti-HCV antibody and/or HCV RNA). People with current HCV&#xD;
      infection (HCV RNA positive) will be offered treatment with eight or 12 weeks of&#xD;
      pan-genotypic DAA therapy, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir, as available&#xD;
      on the PBS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 28, 2019</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</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>Change in Hepatitis C prevalence</measure>
    <time_frame>Week 0 to week 144</time_frame>
    <description>Change in the proportion of people with current HCV infection (HCV RNA positive)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Hepatitis C incidence</measure>
    <time_frame>Week 0 to week 144</time_frame>
    <description>Change in HCV incidence will be calculated using person-time of observation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DAA uptake</measure>
    <time_frame>To week 144</time_frame>
    <description>Proportion with HCV infection initiating DAA therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response rate (SVR12 rate)</measure>
    <time_frame>From week 0 to Week 144</time_frame>
    <description>Overall SVR12 rate in those who commence treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HCV reinfection incidence post treatment</measure>
    <time_frame>6 monthly from end of treatment until week 144</time_frame>
    <description>Participants will be assessed six monthly post end of treatment for HCV recurrence.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>HCV Transmission networks within the Aboriginal community</measure>
    <time_frame>At screening for all participants</time_frame>
    <description>HCV viral genome for will be sequenced for all participants from their screening sample. The sequences ill be used for develop a phylogenetic tree which can be used to determine transmission networks within the study population.</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Hepatitis C</condition>
  <condition>Hepatitis</condition>
  <condition>Liver Diseases</condition>
  <condition>Hepatitis, Viral, Human</condition>
  <condition>RNA Virus Infections</condition>
  <condition>Digestive System Diseases</condition>
  <arm_group>
    <arm_group_label>Fingerstick Point of Care GeneXpert HCV Test</arm_group_label>
    <description>Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treat - SOF/VEL</arm_group_label>
    <description>Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treat - G/P</arm_group_label>
    <description>Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fingerstick GeneXpert HCV RNA quantitative assay</intervention_name>
    <description>All participants at risk of HCV infection will receive HCV RNA testing using the GeneXpert finger-stick point-of-care HCV quantitative assay 6 monthly</description>
    <arm_group_label>Fingerstick Point of Care GeneXpert HCV Test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sofosbuvir/velpatesvir</intervention_name>
    <description>Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia</description>
    <arm_group_label>Fingerstick Point of Care GeneXpert HCV Test</arm_group_label>
    <arm_group_label>Treat - SOF/VEL</arm_group_label>
    <other_name>Epclusa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>glecaprevir/pibrentasvir</intervention_name>
    <description>Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia</description>
    <arm_group_label>Fingerstick Point of Care GeneXpert HCV Test</arm_group_label>
    <arm_group_label>Treat - G/P</arm_group_label>
    <other_name>Maviret</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Dried Blood Spot samples for HCV RNA viral load testing and viral genome sequencing&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        People attending Aboriginal health services will be invited to receive HCV RNA testing&#xD;
        using the GeneXpert fingerstick HCV RNA assay. Those found to have active HCV infection&#xD;
        will be offered treatment with one of two pan-genotypic direct acting antiviral therapies&#xD;
        available in Australia (SOF/VEL or G/P)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older;&#xD;
&#xD;
          -  voluntarily signed the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women.&#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>Gerard Estivill</last_name>
    <phone>+612 9385 0900</phone>
    <email>gestivill@kirby.unsw.edu.au</email>
  </overall_contact>
  <location>
    <facility>
      <name>Jullums Lismore Aboriginal Medical Service</name>
      <address>
        <city>Lismore</city>
        <state>New South Wales</state>
        <zip>2480</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Silberberg</last_name>
      <phone>+612 6621 4366</phone>
      <email>peter@jullums.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Walhallow Aboriginal Corporation</name>
      <address>
        <city>Quirindi</city>
        <state>New South Wales</state>
        <zip>2343</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suruchi Amarasena, MBBS</last_name>
      <phone>+612 6746 2001</phone>
      <email>suruchiaaa@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pangula Mannamurna Aboriginal Corporation</name>
      <address>
        <city>Mount Gambier</city>
        <state>South Australia</state>
        <zip>5290</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kellie Morello</last_name>
      <phone>+61 8 8724 7270</phone>
      <email>kellie.m@pangula.org.au</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Port Lincoln Aboriginal Health Service</name>
      <address>
        <city>Port Lincoln</city>
        <state>South Australia</state>
        <zip>5606</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sharon Bilney</last_name>
      <phone>+618 8683 0162</phone>
      <email>Sharon.Bilney@plahs.org.au</email>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</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>RNA Virus Infections</mesh_term>
    <mesh_term>Hepatitis, Viral, Human</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir</mesh_term>
  </intervention_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/NCT03776760
org study id: VHCRP1802
nct id: NCT03776760
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
A community-based "test and treat" intervention integrating point-of-care HCV RNA testing,
      non-invasive liver disease assessment and linkage to care will lead to a reduction in HCV
      prevalence among people attending Aboriginal health services.
SCALE-C is an interventional cohort study recruiting people with or at risk of HCV infection
      from Aboriginal health services in Australia. Participants will be screened for HCV infection
      using point-of-care testing (anti-HCV antibody and/or HCV RNA). People with current HCV
      infection (HCV RNA positive) will be offered treatment with eight or 12 weeks of
      pan-genotypic DAA therapy, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir, as available
      on the PBS.
observational model: Cohort
time perspective: Prospective
measure: Change in Hepatitis C prevalence
time frame: Week 0 to week 144
description: Change in the proportion of people with current HCV infection (HCV RNA positive)
measure: Change in Hepatitis C incidence
time frame: Week 0 to week 144
description: Change in HCV incidence will be calculated using person-time of observation.
measure: DAA uptake
time frame: To week 144
description: Proportion with HCV infection initiating DAA therapy
measure: Treatment response rate (SVR12 rate)
time frame: From week 0 to Week 144
description: Overall SVR12 rate in those who commence treatment
measure: HCV reinfection incidence post treatment
time frame: 6 monthly from end of treatment until week 144
description: Participants will be assessed six monthly post end of treatment for HCV recurrence.
measure: HCV Transmission networks within the Aboriginal community
time frame: At screening for all participants
description: HCV viral genome for will be sequenced for all participants from their screening sample. The sequences ill be used for develop a phylogenetic tree which can be used to determine transmission networks within the study population.
arm group label: Fingerstick Point of Care GeneXpert HCV Test
description: Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.
arm group label: Treat - SOF/VEL
description: Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir
arm group label: Treat - G/P
description: Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir
intervention type: Device
intervention name: Fingerstick GeneXpert HCV RNA quantitative assay
description: All participants at risk of HCV infection will receive HCV RNA testing using the GeneXpert finger-stick point-of-care HCV quantitative assay 6 monthly
arm group label: Fingerstick Point of Care GeneXpert HCV Test
intervention type: Drug
intervention name: sofosbuvir/velpatesvir
description: Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
arm group label: Fingerstick Point of Care GeneXpert HCV Test
arm group label: Treat - SOF/VEL
other name: Epclusa
intervention type: Drug
intervention name: glecaprevir/pibrentasvir
description: Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
arm group label: Fingerstick Point of Care GeneXpert HCV Test
arm group label: Treat - G/P
other name: Maviret
Dried Blood Spot samples for HCV RNA viral load testing and viral genome sequencing
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gerard Estivill
phone: +612 9385 0900
email: gestivill@kirby.unsw.edu.au
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Australia
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: RNA Virus Infections
mesh term: Hepatitis, Viral, Human
mesh term: Hepatitis
mesh term: Liver Diseases
mesh term: Digestive System Diseases
mesh term: Gastrointestinal Diseases
mesh term: Sofosbuvir