The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection

Status: Recruiting
Location: See all (56) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). Participants will attend a single visit to have their HCV RNA status tested and complete a self-administered survey. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Provided informed consent.

• ≥ 18 years of age.

• Have a risk factor for the acquisition of HCV infection (including current or past injecting drug use, previous incarceration, HIV infection, receiving blood products prior to 1990, having a tattoo or piercing in an unregulated environment, a needle-stick injury, or a mother with HCV).

• OR:

• Are attending a service caring for people with risk factors for the acquisition of HCV infection (e.g. drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, and homelessness services).

Locations
Other Locations
Australia
Central Adelaide Local Health Network
RECRUITING
Adelaide
Drug and Alcohol Services South Australia
RECRUITING
Adelaide
North Adelaide Local Health Network
NOT_YET_RECRUITING
Adelaide
South Adelaide Local Health Network
RECRUITING
Adelaide
ADSCA - Alice Springs Hospital
RECRUITING
Alice Springs
Western NSW LHD
RECRUITING
Bathurst
Alcohol and Harm Reduction Biala
NOT_YET_RECRUITING
Brisbane
Micah Projects
RECRUITING
Brisbane
Far West LHD
NOT_YET_RECRUITING
Broken Hill
Maari Ma Health Aboriginal Corporation
RECRUITING
Broken Hill
Peer Based Harm Reduction Bunbury
RECRUITING
Bunbury
Cairns Sexual Health Service
SUSPENDED
Cairns
Hepatitis ACT
RECRUITING
Canberra
Galambila Aboriginal Health Service
ACTIVE_NOT_RECRUITING
Coffs Harbour
Hepatitis QLD
RECRUITING
Coorparoo
Western Health
NOT_YET_RECRUITING
Footscray
South Terrace Clinic - Fremantle Hospital
NOT_YET_RECRUITING
Fremantle
Central Coast LHD
NOT_YET_RECRUITING
Gosford
Hepatitis SA
NOT_YET_RECRUITING
Hackney
Clinic 60 (Sexual Health Services)
RECRUITING
Hobart
Kombi Clinic
RECRUITING
Inala
Metro South Addiction Services - Inala ADS
NOT_YET_RECRUITING
Inala
Armajun Health Service Aboriginal Corporation
ACTIVE_NOT_RECRUITING
Inverell
Ipswich AODS
NOT_YET_RECRUITING
Ipswich
Ipswich Sexual Health and BBV Service, West Moreton Health
TERMINATED
Ipswich
Rekindling the Spirit Health Service
RECRUITING
Lismore
OneBridge
NOT_YET_RECRUITING
Maroochydore
Eastern Health
NOT_YET_RECRUITING
Melbourne
St Vincent's Hospital (Melbourne)
RECRUITING
Melbourne
Youth Projects - The Living Room
NOT_YET_RECRUITING
Melbourne
Latrobe Community Health Service Liited
NOT_YET_RECRUITING
Morwell
Pangula Mannamurna Aboriginal Corporation
ACTIVE_NOT_RECRUITING
Mount Gambier
Moreton Group Rural Health
TERMINATED
New Town
Nepean Blue Mountains LHD
RECRUITING
Penrith
Hepatitis WA
RECRUITING
Perth
Next Step East Perth
NOT_YET_RECRUITING
Perth
Next Step Fremantle
NOT_YET_RECRUITING
Perth
Next Step Warwick
NOT_YET_RECRUITING
Perth
Peer Based Harm Reduction WA
RECRUITING
Perth
North and Mid North Coast LHD
RECRUITING
Port Macquarie
Walhallow Aboriginal Corporation
RECRUITING
Quirindi
Bulgarr Ngaru Medical Aboriginal Corporation
RECRUITING
South Grafton
Hepatitis NSW
NOT_YET_RECRUITING
Sydney
Kirketon Road Centre
RECRUITING
Sydney
NSLHD
RECRUITING
Sydney
NSW Users and AIDS Association
RECRUITING
Sydney
Prince of Wales Hospital
RECRUITING
Sydney
SESLHD Community and Mental Health POCT Allicance (SCAMPA)
RECRUITING
Sydney
SESLHD Drug Health
NOT_YET_RECRUITING
Sydney
South West Sydney LHD
RECRUITING
Sydney
Storr Liver Clinic (Westmead Hospital)
RECRUITING
Sydney
Sydney Local Health District
RECRUITING
Sydney
WSLHD Drug Health
RECRUITING
Sydney
Murrumbidgee & Southern LHD
RECRUITING
Wagga Wagga
Hunter New England LHD
RECRUITING
Waratah
ISLHD Drug and Alcohol Service
RECRUITING
Wollongong
Contact Information
Primary
David C Silk, BSc
dsilk@kirby.unsw.edu.au
+61293850900
Time Frame
Start Date: 2022-02-22
Estimated Completion Date: 2026-12
Participants
Target number of participants: 40000
Treatments
People at risk of HCV acquisition
This is an observational cohort study. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. Participants will attend a single visit to receive point-of-care HCV testing and complete a self-administered survey. Testing will be performed using point-of-care HCV antibody testing (results within 1-20 minutes, depending on the test) and if positive, HCV RNA testing will be performed. Participants who have previously had HCV infection or previously received HCV treatment will be tested using point-of-care HCV RNA testing. Participants will not receive treatment as a part of this study. Participants who are HCV RNA detectable will be linked to standard of care for any other clinical assessments and treatment initiation.
Related Therapeutic Areas
Sponsors
Collaborators: Flinders University
Leads: Kirby Institute

This content was sourced from clinicaltrials.gov

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