- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04014179
Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs (TEMPO)
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
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:
- HCV testing from collected dried blood spots sent to a central laboratory
- HCV testing using a point-of-care device at the NSP site
- HCV testing using standard of care at the NSP site
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The TEMPO study will compare dried blood spot testing and point-of-care HCV RNA testing to standard of care as strategies to enhance HCV treatment uptake among people with HCV and recent injecting drug use attending NSP services. Peer support to enhance engagement and facilitate linkage to nursing care will be provided in the intervention arms of this study.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elise Tu, PhD
- Phone Number: 61-2-9385-9000
- Email: etu@kirby.unsw.edu.au
Study Locations
-
-
New South Wales
-
Bankstown, New South Wales, Australia, 2200
- Not yet recruiting
- Bankstown NSP
-
Principal Investigator:
- Gilbert Whitton
-
Blacktown, New South Wales, Australia, 2148
- Recruiting
- WSLHD Drug Health - Blacktown NSP
-
Principal Investigator:
- Thao Lam
-
Coffs Harbour, New South Wales, Australia, 2450
- Recruiting
- Coffs Harbour Primary NSP
-
Principal Investigator:
- Alexandra Wade
-
Gosford, New South Wales, Australia, 2250
- Not yet recruiting
- Gosford NSP
-
Principal Investigator:
- Amanda Burfitt
-
Grafton, New South Wales, Australia, 2460
- Recruiting
- Grafton Primary NSP
-
Principal Investigator:
- Alex Wade
-
Kempsey, New South Wales, Australia, 2440
- Recruiting
- Kempsey Primary NSP
-
Principal Investigator:
- Alexandra Wade
-
Lismore, New South Wales, Australia, 2480
- Withdrawn
- Lismore Primary NSP
-
Liverpool, New South Wales, Australia, 2170
- Recruiting
- Liverpool Southwest NSP
-
Principal Investigator:
- Gilbert Whitton
-
Mount Druitt, New South Wales, Australia, 2770
- Recruiting
- WSLHD Drug Health - Mt Druitt NSP
-
Principal Investigator:
- Thao Lam
-
Tweed Heads, New South Wales, Australia, 2485
- Withdrawn
- Tweed Primary NSP
-
Wollongong, New South Wales, Australia, 2500
- Recruiting
- Orana Centre
-
Principal Investigator:
- David Reid
-
-
Queensland
-
Brisbane, Queensland, Australia, 4000
- Recruiting
- Alcohol and Drug Harm Reduction Biala
-
Principal Investigator:
- Jeremy Hayllar
-
Cairns, Queensland, Australia, 4870
- Not yet recruiting
- Severin St NSP (Youth Link)
-
Principal Investigator:
- Daniel Morris
-
Inala, Queensland, Australia, 4077
- Not yet recruiting
- Inala
-
Principal Investigator:
- Holly McCormick
-
Toowoomba, Queensland, Australia, 4350
- Recruiting
- Kobi House
-
Principal Investigator:
- Matthew Ruhl
-
-
South Australia
-
Adelaide, South Australia, Australia, 5000
- Active, not recruiting
- UC Adelaide
-
Adelaide, South Australia, Australia, 5015
- Active, not recruiting
- Wonggangga Turtpandi Aboriginal Primary Health Care Services
-
Elizabeth, South Australia, Australia, 5112
- Active, not recruiting
- Northern DASSA
-
Noarlunga, South Australia, Australia, 5168
- Recruiting
- Noarlunga Health Precinct
-
Principal Investigator:
- Alan Wigg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria for participants:
Attendees of the NSP service are eligible for inclusion if the following criteria are met:
- Provided written informed consent
- ≥ 18 years of age
- Recent injecting drug use - defined as self-reported use within the previous six months.
Exclusion criteria for participants:
a. Is unable or unwilling to provide informed consent or abide by the requirements of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dried Blood Spot (Intervention)
Blood samples will be tested for HCV RNA from dried blood spot cards.
|
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. |
Experimental: Point-of-care RNA (Intervention)
Blood samples will be tested for HCV RNA using the Xpert HCV Viral Load Fingerstick point-of-care assay.
|
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.
|
No Intervention: Standard of Care (Control)
Sites will continue with their standard of care for hepatitis C testing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of HCV RNA positive who initiate HCV treatment
Time Frame: 12 weeks from Enrolment
|
To compare the proportion of HCV RNA positive participants who initiate HCV treatment at 12 weeks following enrolment between those who receive point-of-care HCV RNA testing, dried blood spot testing, and standard of care.
|
12 weeks from Enrolment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Disease Attributes
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Chronic Disease
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
Other Study ID Numbers
- VHCRP1904
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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