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

NCT03776760 | Unknown

• 1 other identifier: VHCRP1802
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

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.

Conditions

Hepatitis C; Hepatitis; Liver Diseases; Hepatitis, Viral, Human; RNA Virus Infections; Digestive System Diseases

Outcome Measures

Primary Outcomes (1)

• Change in Hepatitis C prevalence

  Change in the proportion of people with current HCV infection (HCV RNA positive)

  Week 0 to week 144

Secondary Outcomes (4)

• Change in Hepatitis C incidence

  Week 0 to week 144

• DAA uptake

  To week 144

• Treatment response rate (SVR12 rate)

  From week 0 to Week 144

• HCV reinfection incidence post treatment

  6 monthly from end of treatment until week 144

Other Outcomes (1)

• HCV Transmission networks within the Aboriginal community

  At screening for all participants

Study Arms (3)

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; Drug: sofosbuvir/velpatesvir; Drug: glecaprevir/pibrentasvir

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

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

Interventions

Fingerstick GeneXpert HCV RNA quantitative assay DEVICE

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

Fingerstick Point of Care GeneXpert HCV Test

sofosbuvir/velpatesvir DRUG

Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

Also known as: Epclusa

Fingerstick Point of Care GeneXpert HCV Test; Treat - SOF/VEL

glecaprevir/pibrentasvir DRUG

Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

Also known as: Maviret

Fingerstick Point of Care GeneXpert HCV Test; Treat - G/P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• Pregnant women.

Sponsors & Collaborators

• Kirby Institute: lead
• South Australian Health and Medical Research Institute: collaborator
• Flinders University: collaborator

Study Sites (4)

Jullums Lismore Aboriginal Medical Service

Lismore, New South Wales, 2480, Australia

RECRUITING

Walhallow Aboriginal Corporation

Quirindi, New South Wales, 2343, Australia

RECRUITING

Pangula Mannamurna Aboriginal Corporation

Mount Gambier, South Australia, 5290, Australia

RECRUITING

Port Lincoln Aboriginal Health Service

Port Lincoln, South Australia, 5606, Australia

RECRUITING

Related Publications (1)

• Hosseini-Hooshyar S, Valerio H, Flynn E, Sexton C, Barzi F, Amarasena S, De Koster L, Sellen D, Winterfield N, Grebely J, Matthews GV, Boyd MA, Applegate TL, Petoumenos K, Lafferty L, Dore GJ, Treloar C, Martinello M, Ward J. A point-of-care testing intervention to improve hepatitis C diagnosis and treatment uptake among people attending Aboriginal community controlled health services: the SCALE-C study. BMC Infect Dis. 2025 Nov 17;25(1):1604. doi: 10.1186/s12879-025-12004-z.

  PMID: 41250046 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dried Blood Spot samples for HCV RNA viral load testing and viral genome sequencing

MeSH Terms

Conditions

Hepatitis C; Hepatitis; Liver Diseases; Hepatitis, Viral, Human; RNA Virus Infections; Digestive System Diseases

Interventions

Sofosbuvir; sofosbuvir-velpatasvir drug combination; glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Virus Diseases; Flaviviridae Infections

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Central Study Contacts

Gerard Estivill

CONTACT

+612 9385 0900; gestivill@kirby.unsw.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 17, 2018
• Study Start: May 28, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

AU (4)