Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs
NCT ID: NCT04014179
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2700 participants
INTERVENTIONAL
2022-07-27
2026-07-31
Brief Summary
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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
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Detailed Description
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The study is a cluster randomized controlled trial. The sites (clusters) will be primary NSPs which provide services to people who inject drugs and have capacity to provide hepatitis C treatment services. The sites will be located in Australia.
Eighteen NSPs (the clusters) will be randomly allocated to receive point-of-care HCV RNA testing (6 clusters), dried blood spot testing (6 clusters) or standard of care (6 clusters).
At screening, participants will be tested for HCV infection with dried blood spot, point-of-care or standard of care, depending on cluster randomisation.
Screening will continue until a total of 150 HCV RNA positive participants (\~25 participants per site) are enrolled in the dried blood spot arm, 150 HCV RNA positive participants are enrolled in the point-of-care arm, and 150 participants are enrolled in the standard of care arm. Hence a total of 450 HCV RNA positive participants.
HCV RNA negative participants will have no further assessments or visits as part of the study protocol.
Participants who are HCV RNA positive will be enrolled in the follow-up cohort and will be assessed for treatment eligibility. If eligible, they will be treated as per standard of care with a pharmaceutical benefits scheme (PBS) approved pan-genotypic HCV DAA treatment. Participants will be encouraged to take the first dose on the day of treatment work-up where possible. On-treatment and post-treatment testing and monitoring will be based on the site investigator as per standard clinical practice.
All HCV RNA positive participants will be followed up at 12 weeks, 24 weeks and 12 months post enrolment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Dried Blood Spot (Intervention)
Blood samples will be tested for HCV RNA from dried blood spot cards.
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.
Point-of-care RNA (Intervention)
Blood samples will be tested for HCV RNA using the Xpert HCV Viral Load Fingerstick point-of-care assay.
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.
Standard of Care (Control)
Sites will continue with their standard of care for hepatitis C testing.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
1. Provided written informed consent
2. ≥ 18 years of age
3. Recent injecting drug use - defined as self-reported use within the previous six months.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Kirby Institute
OTHER_GOV
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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VHCRP1904
Identifier Type: -
Identifier Source: org_study_id
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