Hepatitis CTEMPONCT04014179
Enhancing Hepatitis C Testing and Treatment Among People Who Inject Drugs Attending Needle and Syringe Programs
A study testing Xpert HCV Viral Load Fingerstick and Aptima HCV Quant DX Assay in people with Hepatitis C and Hepatitis C, Chronic, run by Kirby Institute at 17 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Hepatitis C, Chronic
- What is being tested?
- Xpert HCV Viral Load Fingerstick and Aptima HCV Quant DX Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,801 participants
- Where
- 17 sitesAustralia
- Study dates
- 27 Jul 2022to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Is unable or unwilling to provide informed consent or abide by the requirements of the study.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Australia17 sites
UC Adelaide
Adelaide, South Australia, 5000
Wonggangga Turtpandi Aboriginal Primary Health Care Services
Adelaide, South Australia, 5015
Bankstown NSP
Bankstown, New South Wales, 2200
WSLHD Drug Health - Blacktown NSP
Blacktown, New South Wales, 2148
Alcohol and Drug Harm Reduction Biala
Brisbane, Queensland, 4000
Severin St NSP (Youth Link)
Cairns, Queensland, 4870
Coffs Harbour Primary NSP
Coffs Harbour, New South Wales, 2450
Northern DASSA
Elizabeth, South Australia, 5112
Gosford NSP
Gosford, New South Wales, 2250
Grafton Primary NSP
Grafton, New South Wales, 2460
Inala
Inala, Queensland, 4077
Kempsey Primary NSP
Kempsey, New South Wales, 2440
Liverpool Southwest NSP
Liverpool, New South Wales, 2170
WSLHD Drug Health - Mt Druitt NSP
Mount Druitt, New South Wales, 2770
Noarlunga Health Precinct
Old Noarlunga, South Australia, 5168
Kobi House
Toowoomba, Queensland, 4350
Orana Centre
Wollongong, New South Wales, 2500
About this study
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
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
Read the 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.
- Conditions
- Hepatitis C, Hepatitis C, Chronic
- Being tested
- Xpert HCV Viral Load Fingerstick, Aptima HCV Quant DX Assay
- Keywords
- Hepatitis C Virus, Needle and Syringe Programs
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert HCV Viral Load FingerstickDiagnostic test
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 AssayDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Dried Blood Spot (Intervention) | Experimental | Blood samples will be tested for HCV RNA from dried blood spot cards. Receives: Diagnostic Test: Aptima HCV Quant DX Assay |
| Point-of-care RNA (Intervention) | Experimental | Blood samples will be tested for HCV RNA using the Xpert HCV Viral Load Fingerstick point-of-care assay. Receives: Diagnostic Test: Xpert HCV Viral Load Fingerstick |
| Standard of Care (Control) | No intervention | Sites will continue with their standard of care for hepatitis C testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks from Enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start27 Jul 2022
- Primary completion22 Jul 2025
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,801 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014179
- Sponsor's protocol ID
- VHCRP1904
- Acronym
- TEMPO
- Status last verified
- May 2026
- First submitted
- 7 Jul 2019
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04014179
- Acronym / sponsor ID
- TEMPO / VHCRP1904
- Conditions
- Hepatitis C, Hepatitis C, Chronic
- Keywords
- Hepatitis C Virus, Needle and Syringe Programs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,801 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dried Blood Spot (Intervention) | Experimental | Diagnostic Test: Aptima HCV Quant DX AssayBlood samples will be tested for HCV RNA from dried blood spot cards. |
| Point-of-care RNA (Intervention) | Experimental | Diagnostic Test: Xpert HCV Viral Load FingerstickBlood samples will be tested for HCV RNA using the Xpert HCV Viral Load Fingerstick point-of-care assay. |
| Standard of Care (Control) | No intervention | –Sites will continue with their standard of care for hepatitis C testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Is unable or unwilling to provide informed consent or abide by the requirements of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert HCV Viral Load FingerstickThe 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. | Diagnostic test | Point-of-care RNA (Intervention) |
| Aptima HCV Quant DX AssayThe 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. | Diagnostic test | Dried Blood Spot (Intervention) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xpert HCV Viral Load Fingerstick and Aptima HCV Quant DX Assay in people with Hepatitis C and Hepatitis C, Chronic, run by Kirby Institute at 17 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of HCV RNA positive who initiate HCV treatment (time frame: 12 weeks from Enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.