Hepatitis C Clinical Trial
— SCALE-COfficial title:
Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
NCT number | NCT03776760 |
Other study ID # | VHCRP1802 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 28, 2019 |
Est. completion date | August 2022 |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Kirby Institute | Flinders University, South Australian Health and Medical Research Institute |
Australia,
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 |
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