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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03776760




Registration number
NCT03776760
Ethics application status
Date submitted
21/11/2018
Date registered
17/12/2018
Date last updated
14/04/2022

Titles & IDs
Public title
Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
Scientific title
Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
Secondary ID [1] 0 0
VHCRP1802
Universal Trial Number (UTN)
Trial acronym
SCALE-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Hepatitis 0 0
Liver Diseases 0 0
Hepatitis, Viral, Human 0 0
RNA Virus Infections 0 0
Digestive System Diseases 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Fingerstick GeneXpert HCV RNA quantitative assay
Treatment: Drugs - sofosbuvir/velpatesvir
Treatment: Drugs - glecaprevir/pibrentasvir

Fingerstick Point of Care GeneXpert HCV Test - Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.

Treat - SOF/VEL - Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - 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


Treatment: Devices: 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

Treatment: Drugs: sofosbuvir/velpatesvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

Treatment: Drugs: glecaprevir/pibrentasvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Hepatitis C prevalence
Timepoint [1] 0 0
Week 0 to week 144
Secondary outcome [1] 0 0
Change in Hepatitis C incidence
Timepoint [1] 0 0
Week 0 to week 144
Secondary outcome [2] 0 0
DAA uptake
Timepoint [2] 0 0
To week 144
Secondary outcome [3] 0 0
Treatment response rate (SVR12 rate)
Timepoint [3] 0 0
From week 0 to Week 144
Secondary outcome [4] 0 0
HCV reinfection incidence post treatment
Timepoint [4] 0 0
6 monthly from end of treatment until week 144

Eligibility
Key inclusion criteria
* 18 years of age or older;
* voluntarily signed the informed consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnant women.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2022
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Jullums Lismore Aboriginal Medical Service - Lismore
Recruitment hospital [2] 0 0
Walhallow Aboriginal Corporation - Quirindi
Recruitment hospital [3] 0 0
Pangula Mannamurna Aboriginal Corporation - Mount Gambier
Recruitment hospital [4] 0 0
Port Lincoln Aboriginal Health Service - Port Lincoln
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2343 - Quirindi
Recruitment postcode(s) [3] 0 0
5290 - Mount Gambier
Recruitment postcode(s) [4] 0 0
5606 - Port Lincoln

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
South Australian Health and Medical Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Flinders University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03776760
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gerard Estivill
Address 0 0
Country 0 0
Phone 0 0
+612 9385 0900
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03776760