Det nationale australske HCV Point-of-Care-testprogram - Minimalt datasæt for HCV-antistoftestning
Det nationale australske HCV Point-of-Care-testprogram: En observationel kohorteundersøgelse til evaluering af brugen af finger-stick Point-of-care Hepatitis C-testning for at forbedre diagnosticering og behandling af HCV-infektion - HCV-antistoftest Minimalt datasæt
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Stephanie Davey, BSc
- Telefonnummer: +61293481404
- E-mail: sdavey@kirby.unsw.edu.au
Undersøgelse Kontakt Backup
- Navn: David Silk, BSc
- Telefonnummer: +61293850900
- E-mail: dsilk@kirby.unsw.edu.au
Studiesteder
-
-
Australian Capital Territory
-
Canberra, Australian Capital Territory, Australien
- Ikke rekrutterer endnu
- ACT Justice Health
-
Kontakt:
- Alex Misev
-
Ledende efterforsker:
- Alex Misev, Dr
-
-
New South Wales
-
Sydney, New South Wales, Australien
- Rekruttering
- Justice Health and Forensic Mental Health Network
-
Kontakt:
- Tracey Brown
-
-
Queensland
-
Bowen Hills, Queensland, Australien, 4006
- Aktiv, ikke rekrutterende
- Queensland Injectors Health Network Ltd
-
Brisbane, Queensland, Australien
- Rekruttering
- West Moreton Hospital and Health Service
-
Kontakt:
- Chris Wallis
- Telefonnummer: (07) 3810 1111
- E-mail: christopher.wallis@health.qld.gov.au
-
Cairns, Queensland, Australien
- Rekruttering
- Lotus Glen Correctional Centre
-
Kontakt:
- Kerry Williamson
- Telefonnummer: (07) 4093 3911
- E-mail: Kerry.Williamson@Corrections.qld.gov.au
-
Townsville, Queensland, Australien, 4810
- Ikke rekrutterer endnu
- Townsville Correctional Centre
-
Kontakt:
- John Morey
-
Woodford, Queensland, Australien
- Rekruttering
- Woodford Correctional Centre
-
Kontakt:
- Lyn Cadman
- Telefonnummer: (07) 5422 5200
- E-mail: lyn.cadman@health.qld.gov.au
-
-
South Australia
-
Adelaide, South Australia, Australien
- Ikke rekrutterer endnu
- South Australian Prison Health Service
-
Kontakt:
- Tom Turnbull
-
Ledende efterforsker:
- Tom Turnbull
-
Hackney, South Australia, Australien, 5069
- Ikke rekrutterer endnu
- Hepatitis South Australia
-
Kontakt:
- Lisa Carter
-
-
Tasmania
-
Hobart, Tasmania, Australien
- Ikke rekrutterer endnu
- Tasmanian Prison Service
-
Kontakt:
- Deborah Siddell
-
Ledende efterforsker:
- Meredith Stronach
-
-
Victoria
-
Melbourne, Victoria, Australien
- Rekruttering
- St Vincent's Hospital (Melbourne)
-
Kontakt:
- Alex Thompson
-
Ledende efterforsker:
- Alex Thompson, Prof
-
-
Western Australia
-
Beechina, Western Australia, Australien, 6558
- Rekruttering
- Acacia Prison
-
Kontakt:
- Tahlia Kinnane
- Telefonnummer: (08) 9573 3300
- E-mail: tahlia.kinnane@serco-ap.com
-
Perth, Western Australia, Australien, 6000
- Ikke rekrutterer endnu
- WA Department of Justice
-
Kontakt:
- Holly Beasley
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
- Provide informed consent
- ≥ 18 years of age.
Exclusion Criteria:
- Is unable or unwilling to provide informed consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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 |
Participants will be offered finger-stick point-of-care testing for HCV |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 12 weeks from enrolment
|
HCV treatment |
12 weeks from enrolment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Tidsramme: Recruitment phase
|
Accepting testing |
Recruitment phase
|
|
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Tidsramme: Recruitment phase
|
Prevalence |
Recruitment phase
|
|
To evaluate the HCV antibody prevalence among people tested.
Tidsramme: Recruitment phase
|
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;
Tidsramme: 52 weeks
|
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.
Tidsramme: 52 weeks
|
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;
Tidsramme: 52 weeks
|
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
Tidsramme: 52 weeks
|
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.
Tidsramme: 52 weeks
|
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.
Tidsramme: 52 weeks
|
Cost-effectiveness |
52 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VHCRP2203
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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