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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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Trial website
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
gestivill@kirby.unsw.edu.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.