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| Name | Class |
|---|---|
| Flinders University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People at risk of HCV acquisition | Clinic staff will offer HCV point-of-care testing to participants as they access services. Testing will be performed using point-of-care HCV RNA testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test: Point-of-Care Testing | Device | Participants will be offered finger-stick point-of-care testing for HCV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | HCV treatment | 12 weeks from enrolment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the proportion of people who accept point-of-care testing among those offered testing. | Accepting testing | Recruitment phase |
| To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be included from settings that provide services to people with a risk factor for the acquisition of HCV infection, including drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, homelessness services, and other appropriate settings nationally. It is anticipated that approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Silk, BSc | Contact | +61293850900 | dsilk@kirby.unsw.edu.au | |
| Stephanie Davey, BSc | Contact | +61293481404 | sdavey@kirby.unsw.edu.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACT Justice Health | Not yet recruiting | Canberra | Australian Capital Territory | Australia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2023 | May 21, 2024 |
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Prevalence
| Recruitment phase |
| To evaluate the HCV antibody prevalence among people tested. | Prevalence | Recruitment phase |
| 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; | Time to treatment | 52 weeks |
| 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. | Initiation of treatment | 52 weeks |
| 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; | Completion of treatment | 52 weeks |
| 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 | SVR | 52 weeks |
| 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. | HCV negative | 52 weeks |
| 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. | Cost-effectiveness | 52 weeks |
| Justice Health and Forensic Mental Health Network | Recruiting | Sydney | New South Wales | Australia |
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| Queensland Injectors Health Network Ltd | Recruiting | Bowen Hills | Queensland | 4006 | Australia |
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| West Moreton Hospital and Health Service | Recruiting | Brisbane | Queensland | Australia |
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| Lotus Glen Correctional Centre | Recruiting | Cairns | Queensland | Australia |
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| Townsville Correctional Centre | Not yet recruiting | Townsville | Queensland | 4810 | Australia |
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| Woodford Correctional Centre | Recruiting | Woodford | Queensland | Australia |
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| South Australian Prison Health Service | Not yet recruiting | Adelaide | South Australia | Australia |
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| Hepatitis South Australia | Not yet recruiting | Hackney | South Australia | 5069 | Australia |
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| Tasmanian Prison Service | Not yet recruiting | Hobart | Tasmania | Australia |
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| St Vincent's Hospital (Melbourne) | Recruiting | Melbourne | Victoria | Australia |
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| WA Department of Justice | Not yet recruiting | Perth | Western Australia | 6000 | Australia |
|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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