Det nasjonale australske HCV Point-of-Care-testingprogrammet - HCV Antibody Testing Minimal Dataset
Det nasjonale australske HCV Point-of-Care-testingprogrammet: En observasjonskohortstudie for å evaluere bruken av Finger-stick Point-of-care Hepatitt C-testing for å forbedre diagnose og behandling av HCV-infeksjon - HCV-antistofftesting Minimalt datasett
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Stephanie Davey, BSc
- Telefonnummer: +61293481404
- E-post: sdavey@kirby.unsw.edu.au
Studer Kontakt Backup
- Navn: David Silk, BSc
- Telefonnummer: +61293850900
- E-post: dsilk@kirby.unsw.edu.au
Studiesteder
-
-
Australian Capital Territory
-
Canberra, Australian Capital Territory, Australia
- Har ikke rekruttert ennå
- ACT Justice Health
-
Ta kontakt med:
- Alex Misev
-
Hovedetterforsker:
- Alex Misev, Dr
-
-
New South Wales
-
Sydney, New South Wales, Australia
- Rekruttering
- Justice Health and Forensic Mental Health Network
-
Ta kontakt med:
- Tracey Brown
-
-
Queensland
-
Bowen Hills, Queensland, Australia, 4006
- Aktiv, ikke rekrutterende
- Queensland Injectors Health Network Ltd
-
Brisbane, Queensland, Australia
- Rekruttering
- West Moreton Hospital and Health Service
-
Ta kontakt med:
- Chris Wallis
- Telefonnummer: (07) 3810 1111
- E-post: christopher.wallis@health.qld.gov.au
-
Cairns, Queensland, Australia
- Rekruttering
- Lotus Glen Correctional Centre
-
Ta kontakt med:
- Kerry Williamson
- Telefonnummer: (07) 4093 3911
- E-post: Kerry.Williamson@Corrections.qld.gov.au
-
Townsville, Queensland, Australia, 4810
- Har ikke rekruttert ennå
- Townsville Correctional Centre
-
Ta kontakt med:
- John Morey
-
Woodford, Queensland, Australia
- Rekruttering
- Woodford Correctional Centre
-
Ta kontakt med:
- Lyn Cadman
- Telefonnummer: (07) 5422 5200
- E-post: lyn.cadman@health.qld.gov.au
-
-
South Australia
-
Adelaide, South Australia, Australia
- Har ikke rekruttert ennå
- South Australian Prison Health Service
-
Ta kontakt med:
- Tom Turnbull
-
Hovedetterforsker:
- Tom Turnbull
-
Hackney, South Australia, Australia, 5069
- Har ikke rekruttert ennå
- Hepatitis South Australia
-
Ta kontakt med:
- Lisa Carter
-
-
Tasmania
-
Hobart, Tasmania, Australia
- Har ikke rekruttert ennå
- Tasmanian Prison Service
-
Ta kontakt med:
- Deborah Siddell
-
Hovedetterforsker:
- Meredith Stronach
-
-
Victoria
-
Melbourne, Victoria, Australia
- Rekruttering
- St Vincent's Hospital (Melbourne)
-
Ta kontakt med:
- Alex Thompson
-
Hovedetterforsker:
- Alex Thompson, Prof
-
-
Western Australia
-
Beechina, Western Australia, Australia, 6558
- Rekruttering
- Acacia Prison
-
Ta kontakt med:
- Tahlia Kinnane
- Telefonnummer: (08) 9573 3300
- E-post: tahlia.kinnane@serco-ap.com
-
Perth, Western Australia, Australia, 6000
- Har ikke rekruttert ennå
- WA Department of Justice
-
Ta kontakt med:
- Holly Beasley
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VHCRP2203
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .