Hepatitis C
Conditions
Keywords
Point-of-Care, Rapid Diagnostic Testing, HCV
Brief summary
The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is: What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis? Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit. No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.
Interventions
DEVICEDiagnostic Test: Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV
Sponsors
Kirby Institute
Flinders University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provide informed consent * ≥ 18 years of age.
Exclusion criteria
* Is unable or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing. | 12 weeks from enrolment | HCV treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the proportion of people who accept point-of-care testing among those offered testing. | Recruitment phase | Accepting testing |
| To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. | Recruitment phase | Prevalence |
| To evaluate the HCV antibody prevalence among people tested. | Recruitment phase | Prevalence |
| To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment; | 52 weeks | Time to treatment |
| To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing. | 52 weeks | Initiation of treatment |
| To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment; | 52 weeks | Completion of treatment |
| To evaluate the proportion of participants who achieve an SVR following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment | 52 weeks | SVR |
| To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing. | 52 weeks | HCV negative |
| To evaluate the cost of point-of-care HCV antibody testing prior to reflex HCV RNA testing compared to direct point-of-care HCV RNA testing and standard of care. | 52 weeks | Cost-effectiveness |
Countries
Australia
Contacts
CONTACTDavid Silk, BSc
CONTACTStephanie Davey, BSc
Outcome results
None listed