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Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination (SCALE-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03776760
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
South Australian Health and Medical Research Institute
Flinders University
Information provided by (Responsible Party):
Kirby Institute

Brief Summary:
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.

Condition or disease Intervention/treatment
Hepatitis C Hepatitis Liver Diseases Hepatitis, Viral, Human RNA Virus Infections Digestive System Diseases Device: Fingerstick GeneXpert HCV RNA quantitative assay Drug: sofosbuvir/velpatesvir Drug: glecaprevir/pibrentasvir

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Group/Cohort Intervention/treatment
Fingerstick Point of Care GeneXpert HCV Test
Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.
Device: Fingerstick GeneXpert HCV RNA quantitative assay
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

Drug: sofosbuvir/velpatesvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
Other Name: Epclusa

Drug: glecaprevir/pibrentasvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
Other Name: Maviret

Treat - SOF/VEL
Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir
Drug: sofosbuvir/velpatesvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
Other Name: Epclusa

Treat - G/P
Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir
Drug: glecaprevir/pibrentasvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
Other Name: Maviret




Primary Outcome Measures :
  1. Change in Hepatitis C prevalence [ Time Frame: Week 0 to week 144 ]
    Change in the proportion of people with current HCV infection (HCV RNA positive)


Secondary Outcome Measures :
  1. Change in Hepatitis C incidence [ Time Frame: Week 0 to week 144 ]
    Change in HCV incidence will be calculated using person-time of observation.

  2. DAA uptake [ Time Frame: To week 144 ]
    Proportion with HCV infection initiating DAA therapy

  3. Treatment response rate (SVR12 rate) [ Time Frame: From week 0 to Week 144 ]
    Overall SVR12 rate in those who commence treatment

  4. HCV reinfection incidence post treatment [ Time Frame: 6 monthly from end of treatment until week 144 ]
    Participants will be assessed six monthly post end of treatment for HCV recurrence.


Other Outcome Measures:
  1. HCV Transmission networks within the Aboriginal community [ Time Frame: At screening for all participants ]
    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.


Biospecimen Retention:   Samples Without DNA
Dried Blood Spot samples for HCV RNA viral load testing and viral genome sequencing


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
People attending Aboriginal health services will be invited to receive HCV RNA testing using the GeneXpert fingerstick HCV RNA assay. Those found to have active HCV infection will be offered treatment with one of two pan-genotypic direct acting antiviral therapies available in Australia (SOF/VEL or G/P)
Criteria

Inclusion Criteria:

  • 18 years of age or older;
  • voluntarily signed the informed consent form.

Exclusion Criteria:

  • Pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776760


Contacts
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Contact: Gerard Estivill +612 9385 0900 gestivill@kirby.unsw.edu.au

Locations
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Australia, New South Wales
Jullums Lismore Aboriginal Medical Service Recruiting
Lismore, New South Wales, Australia, 2480
Contact: Peter Silberberg    +612 6621 4366    peter@jullums.com   
Walhallow Aboriginal Corporation Recruiting
Quirindi, New South Wales, Australia, 2343
Contact: Suruchi Amarasena, MBBS    +612 6746 2001    suruchiaaa@gmail.com   
Australia, South Australia
Port Lincoln Aboriginal Health Service Recruiting
Port Lincoln, South Australia, Australia, 5606
Contact: Sharon Bilney    +618 8683 0162    Sharon.Bilney@plahs.org.au   
Sponsors and Collaborators
Kirby Institute
South Australian Health and Medical Research Institute
Flinders University

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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT03776760    
Other Study ID Numbers: VHCRP1802
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
RNA Virus Infections
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Gastrointestinal Diseases
Virus Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents