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

Hepatitis C Clinical Trial

— SCALE-C  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03776760
• Other study ID #: VHCRP1802
• Status: Recruiting
• Start date: May 28, 2019
• Est. completion date: August 2022

Study information

• Verified date: April 2022
• Source: Kirby Institute
• Contact: Gerard Estivill
• Phone: +612 9385 0900
• Email: gestivill[@]kirby.unsw.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older;

• voluntarily signed the informed consent form.

Exclusion Criteria:

• Pregnant women.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis, Viral, Human
• Liver Diseases
• RNA Virus Infections

Intervention

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

Locations

Country	Name	City	State
Australia	Jullums Lismore Aboriginal Medical Service	Lismore	New South Wales
Australia	Pangula Mannamurna Aboriginal Corporation	Mount Gambier	South Australia
Australia	Port Lincoln Aboriginal Health Service	Port Lincoln	South Australia
Australia	Walhallow Aboriginal Corporation	Quirindi	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
Kirby Institute	Flinders University, South Australian Health and Medical Research Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HCV Transmission networks within the Aboriginal community	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.	At screening for all participants
Primary	Change in Hepatitis C prevalence	Change in the proportion of people with current HCV infection (HCV RNA positive)	Week 0 to week 144
Secondary	Change in Hepatitis C incidence	Change in HCV incidence will be calculated using person-time of observation.	Week 0 to week 144
Secondary	DAA uptake	Proportion with HCV infection initiating DAA therapy	To week 144
Secondary	Treatment response rate (SVR12 rate)	Overall SVR12 rate in those who commence treatment	From week 0 to Week 144
Secondary	HCV reinfection incidence post treatment	Participants will be assessed six monthly post end of treatment for HCV recurrence.	6 monthly from end of treatment until week 144