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Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs
Sponsor: Kirby Institute
Summary
This project aims to evaluate two strategies of Hepatitis C virus (HCV) testing compared to standard of care among people who inject drugs at needle and syringe program (NSP) services in Australia, to see if it can improve the number of people who start treatment following an HCV diagnosis: 1. HCV testing from collected dried blood spots sent to a central laboratory 2. HCV testing using a point-of-care device at the NSP site 3. HCV testing using standard of care at the NSP site
Official title: A Multi-centre, Practice-level, Cluster Randomized Controlled Trial to Compare Point-of-care HCV RNA Testing, Dried Blood Spot Testing, and Standard of Care to Enhance Treatment Uptake Among People With HCV Who Have Recently Injected Drugs Attending Needle and Syringe Programs: the TEMPO Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2700
Start Date
2022-07-27
Completion Date
2026-07-31
Last Updated
2025-07-17
Healthy Volunteers
Yes
Conditions
Interventions
Xpert HCV Viral Load Fingerstick
The Cepheid Xpert HCV Viral Load (VL) Fingerstick assay is an in vitro nucleic acid amplification test designed for the quantitation of Hepatitis C Virus (HCV) DNA in human whole blood using the automated GeneXpert Systems. The HCV RNA result from the Xpert test will be used to initiate HCV treatment.
Aptima HCV Quant DX Assay
The Aptima HCV Quant Dx assay is a real-time transcription-mediated amplification test. The assay is used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals, and in this study from dried blood spots. The HCV RNA result from the Aptima assay will be used to initiate HCV treatment.
Locations (17)
Bankstown NSP
Bankstown, New South Wales, Australia
WSLHD Drug Health - Blacktown NSP
Blacktown, New South Wales, Australia
Coffs Harbour Primary NSP
Coffs Harbour, New South Wales, Australia
Gosford NSP
Gosford, New South Wales, Australia
Grafton Primary NSP
Grafton, New South Wales, Australia
Kempsey Primary NSP
Kempsey, New South Wales, Australia
Liverpool Southwest NSP
Liverpool, New South Wales, Australia
WSLHD Drug Health - Mt Druitt NSP
Mount Druitt, New South Wales, Australia
Orana Centre
Wollongong, New South Wales, Australia
Alcohol and Drug Harm Reduction Biala
Brisbane, Queensland, Australia
Severin St NSP (Youth Link)
Cairns, Queensland, Australia
Inala
Inala, Queensland, Australia
Kobi House
Toowoomba, Queensland, Australia
UC Adelaide
Adelaide, South Australia, Australia
Wonggangga Turtpandi Aboriginal Primary Health Care Services
Adelaide, South Australia, Australia
Northern DASSA
Elizabeth, South Australia, Australia
Noarlunga Health Precinct
Old Noarlunga, South Australia, Australia