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
1 other identifier
interventional
1,801
1 country
17
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2019
CompletedFirst Posted
Study publicly available on registry
July 10, 2019
CompletedStudy Start
First participant enrolled
July 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2026
CompletedJune 3, 2026
May 1, 2026
3 years
July 7, 2019
May 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of HCV RNA positive who initiate HCV treatment
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
Study Arms (3)
Dried Blood Spot (Intervention)
EXPERIMENTALBlood samples will be tested for HCV RNA from dried blood spot cards.
Point-of-care RNA (Intervention)
EXPERIMENTALBlood samples will be tested for HCV RNA using the Xpert HCV Viral Load Fingerstick point-of-care assay.
Standard of Care (Control)
NO INTERVENTIONSites will continue with their standard of care for hepatitis C testing.
Interventions
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.
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
You may qualify if:
- Provided written informed consent
- ≥ 18 years of age
- Recent injecting drug use - defined as self-reported use within the previous six months.
You may not qualify if:
- a. Is unable or unwilling to provide informed consent or abide by the requirements of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kirby Institutelead
Study Sites (17)
Bankstown NSP
Bankstown, New South Wales, 2200, Australia
WSLHD Drug Health - Blacktown NSP
Blacktown, New South Wales, 2148, Australia
Coffs Harbour Primary NSP
Coffs Harbour, New South Wales, 2450, Australia
Gosford NSP
Gosford, New South Wales, 2250, Australia
Grafton Primary NSP
Grafton, New South Wales, 2460, Australia
Kempsey Primary NSP
Kempsey, New South Wales, 2440, Australia
Liverpool Southwest NSP
Liverpool, New South Wales, 2170, Australia
WSLHD Drug Health - Mt Druitt NSP
Mount Druitt, New South Wales, 2770, Australia
Orana Centre
Wollongong, New South Wales, 2500, Australia
Alcohol and Drug Harm Reduction Biala
Brisbane, Queensland, 4000, Australia
Severin St NSP (Youth Link)
Cairns, Queensland, 4870, Australia
Inala
Inala, Queensland, 4077, Australia
Kobi House
Toowoomba, Queensland, 4350, Australia
UC Adelaide
Adelaide, South Australia, 5000, Australia
Wonggangga Turtpandi Aboriginal Primary Health Care Services
Adelaide, South Australia, 5015, Australia
Northern DASSA
Elizabeth, South Australia, 5112, Australia
Noarlunga Health Precinct
Old Noarlunga, South Australia, 5168, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2019
First Posted
July 10, 2019
Study Start
July 27, 2022
Primary Completion
July 22, 2025
Study Completion
April 29, 2026
Last Updated
June 3, 2026
Record last verified: 2026-05