Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination

• Conditions: Hepatitis C; Hepatitis; Liver Diseases; Hepatitis, Viral, Human; RNA Virus Infections; Digestive System Diseases
• Interventions: Device: Fingerstick GeneXpert HCV RNA quantitative assay; Drug: sofosbuvir/velpatesvir; Drug: glecaprevir/pibrentasvir

• Registration Number: NCT03776760
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-17
• Study Start: 2019-05-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14
• Primary Completion: 2022-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

• Pregnant women.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fingerstick Point of Care GeneXpert HCV Test	glecaprevir/pibrentasvir	Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.
Treat - G/P	glecaprevir/pibrentasvir	Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir
Fingerstick Point of Care GeneXpert HCV Test	sofosbuvir/velpatesvir	Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.
Fingerstick Point of Care GeneXpert HCV Test	Fingerstick GeneXpert HCV RNA quantitative assay	Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.
Treat - SOF/VEL	sofosbuvir/velpatesvir	Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir

Primary Outcome Measures

Name	Time	Method
Change in Hepatitis C prevalence	Week 0 to week 144	Change in the proportion of people with current HCV infection (HCV RNA positive)

Secondary Outcome Measures

Name	Time	Method
Change in Hepatitis C incidence	Week 0 to week 144	Change in HCV incidence will be calculated using person-time of observation.
DAA uptake	To week 144	Proportion with HCV infection initiating DAA therapy
Treatment response rate (SVR12 rate)	From week 0 to Week 144	Overall SVR12 rate in those who commence treatment
HCV reinfection incidence post treatment	6 monthly from end of treatment until week 144	Participants will be assessed six monthly post end of treatment for HCV recurrence.

Trial Locations

Locations (4)

Jullums Lismore Aboriginal Medical Service; 🇦🇺 Lismore, New South Wales, Australia

Walhallow Aboriginal Corporation; 🇦🇺 Quirindi, New South Wales, Australia

Pangula Mannamurna Aboriginal Corporation; 🇦🇺 Mount Gambier, South Australia, Australia

Port Lincoln Aboriginal Health Service; 🇦🇺 Port Lincoln, South Australia, Australia