Hepatitis CPhase 4NCT05016609
Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)
A Phase 4 study testing OraQuick HCV Antibody test (OraSure Technologies, Inc), Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) and Sofosbuvir/Velpatasvir (Gilead) in people with Hepatitis C, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 6 sites in Australia.
Trial summary
The QuickStart study aims to assess the impact of three models of HCV care on HCV treatment uptake and cure among people who inject drugs. Rapid point-of-care (POC) HCV testing and test-and-treat strategies will be utilised in primary health care settings across Australia. 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
- What is being tested?
- OraQuick HCV Antibody test (OraSure Technologies, Inc), Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) and Sofosbuvir/Velpatasvir (Gilead)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 6 sitesAustralia
- Study dates
- 9 Mar 2022to Jun 2024
- Phase
- Phase 4
- 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
- current or former PWID (i.e., injected drugs at least once)
- aged 18 years or over
- attending a participating PHC for any reason
- no previous treatment with DAAs for HCV
- failed interferon based treatment for HCV in the past (i.e., did not achieve cure)
- Medicare eligible
- able to speak and understand English
Who cannot join
- women known to be currently pregnant or who are breastfeeding
- individuals self-reporting to be currently engaged in treatment for HCV
- unable to provide informed consent
- tested for HCV in the past 3 months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites, 6 recruiting
- Recruiting
Mediclinic Australia
Clayton South, Victoria, 3168
Ainslee O'Donnell, +61395441555, ainslee@mediclinicclayton.com.au
Ernesto Andrada
- Recruiting
Innerspace
Collingwood, Victoria, 3066
Tanya Karapouloutidis, +61394486710, tanya.karapouloutidis@cohealth.org.au
Dean Membrey
- Recruiting
Corio Community Health Centre
Corio, Victoria, 3214
Inga Tribe, +613 4215 7100, inga.tribe@barwonhealth.org.au
Amanda Wade
- Recruiting
Cohealth Fitzroy
Fitzroy, Victoria, 3065.
Tanya Karapouloutidis, (03) 9448 5531, tanya.karapouloutidis@cohealth.org.au
Paul MacCartney
- Recruiting
Homeless Healthcare
Highgate, Western Australia, 6003
Denice Wallis, +618 62602092, denice.wallis@hhc.org.au
Andrew Davies
- Recruiting
Cockburn Wellbeing
Success, Western Australia, 6164
Karen Heslop, +618 9266 2090, k.heslop@curtin.edu.au
Calum Ross
About this study
Official title: Same-visit Hepatitis C Testing and Treatment to Accelerate Cure Among People Who Inject Drugs: a Cluster Randomised Control Trial (The QuickStart Study)
The QuickStart study aims to assess the impact of three models of HCV care on HCV treatment uptake and cure among people who inject drugs. Rapid point-of-care (POC) HCV testing and test-and-treat strategies will be utilised in primary health care settings across Australia.
Read the detailed description
The QuickStart Study will explore models of point-of-care HCV testing and a same-day test and treat model to determine the impact of these models on HCV treatment initiation and cure. The study is a cluster cross-over randomised controlled trial. Sites are primary care services in Australia who provide services to people who inject drugs (PWID) and who routinely prescribe treatment for hepatitis C. Clinical services with a primary care practitioner and/or nurse experienced in providing DAA treatment to high numbers of PWID will be recruited to the study. A total of 30 services will be recruited with each service enrolling approximately 60 participants across an intervention and control period. Key participant eligibility include a history of injecting drug use and no previous treatment for HCV with direct acting antivirals.
Each site will participate in a control comparison period in addition to one of three interventions. The three interventions involve:
- A rapid HCV antibody test using a fingerprick sample and for anybody subsequently diagnosed with hepatitis C, management and treatment will be according to standard of care.
- A rapid HCV antibody test followed by a POC HCV RNA test for those who return a reactive antibody result. Both these will use a fingerprick sample and for anybody diagnosed with hepatitis C, management and treatment will be according to standard of care.
- A rapid HCV antibody test using a fingerprick sample and for participants who return a reactive result, an initial starter pack of DAA prior to a confirmed HCV RNA diagnosis.
- Conditions
- Hepatitis C
- Being tested
- OraQuick HCV Antibody test (OraSure Technologies, Inc), Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid), Sofosbuvir/Velpatasvir (Gilead)
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraQuick HCV Antibody test (OraSure Technologies, Inc)Device
The OraQuick HCV test is a point of care antibody test for detecting HCV antibodies in fingerstick blood. The test takes 20 minutes to provide a result. Appropriate pre- and post-test counselling will be provided to participants.
Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)Device
Xpert® HCV VL Fingerstick is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human venous and capillary fingerstick EDTA whole blood. Only participants who return a reactive OraQuick HCV Antibody test will be offered the Xpert® HCV VL Fingerstick test. Appropriate pre- and post-test counselling will be provided to participants.
Sofosbuvir/Velpatasvir (Gilead)Drug
Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir.
| Study group | Role | What they receive |
|---|---|---|
| POC HCV antibody group (Arm A) | Experimental | This group will receive POC HCV antibody testing via fingerprick using the OraQuick HCV antibody test (OraSure) in addition to the standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. Follow up and management of any treatment will be through usual standard-of-care. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire. Receives: Device: OraQuick HCV Antibody test (OraSure Technologies, Inc) |
| POC HCV RNA group (Arm B) | Experimental | This group will receive POC HCV antibody testing using the OraQuick HCV antibody test. Participants in this group who return a positive POC HCV antibody result will receive POC HCV viral load testing via fingerstick using the Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) in addition to the standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. Follow up and management of any treatment will be through usual standard-of-care. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire. Receives: Device: OraQuick HCV Antibody test (OraSure Technologies, Inc); Device: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) |
| Test and treat group (ArmC) | Experimental | This group will receive POC HCV antibody testing using the OraQuick HCV antibody test. Participants in this group who return a positive POC HCV antibody result will be provided a starter pack of HCV treatment (epclusa). POC tests results will be confirmed through standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. HCV RNA positive participants will continue treatment. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire. Receives: Device: OraQuick HCV Antibody test (OraSure Technologies, Inc); Drug: Sofosbuvir/Velpatasvir (Gilead) |
| Control | No intervention | This group will receive the standard of care for HCV testing and treatment. Participants in this group will fill out a short behavioural questionnaire and a clinical questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV treatment
The number of participants who start HCV treatment in each of the intervention arms (Arm A, Arm B or Arm C) within 12 weeks of enrolment, compared with standard care testing and treatment (Control Arm).
Measured: Within 12 weeks of enrolment
HCV cure
The number of participants who achieve HCV cure in each of the intervention arms (Arm A, Arm B or Arm C), compared with standard care testing and treatment (Control Arm).
Measured: HCV cure will be measured between 4 and 20 weeks post treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start9 Mar 2022
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A cluster cross-over randomised controlled trial with cluster randomisation performed at the site level. Each site will be randomised to one of the three interventions and one standard of care period. All participants will receive the intervention or comparator that has been allocated to the service they present at.
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Doyle, MBBS, PhD, Principal investigator, Burnet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016609
- Sponsor's protocol ID
- HREC/64731/Alfred-2020-217547
- Status last verified
- Nov 2023
- First submitted
- 16 Aug 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: Requests for data sharing can be made to the principal investigator; further approval by the Human Research Ethics Committee may be necessary given the sensitive behaviour and risk information collected in the context of a trial of people who use drugs and hepatitis C testing.
Publications
Heath K, Guzman R, Elsum I, Wade AJ, Allardice K, Kasza J, Bryant M, Thompson AJ, Stoove M, Snelling T, Scott N, Spelman T, Anderson DA, Richmond J, Howell J, Andric N, Dietze P, Higgs P, Sacks-Davis R, Forbes A, Hellard ME, Pedrana AE, Doyle JS. Balancing Efficiency and Accuracy in Hepatitis C Rapid Antibody Testing: Insights From a Cluster Randomised Crossover Trial. J Viral Hepat. 2025 Aug;32(8):e70043. doi: 10.1111/jvh.70043.
PubMed 40607684Doyle JS, Heath K, Elsum I, Douglass C, Wade A, Kasza J, Allardice K, Von Bibra S, Chan K, Camesella B, Guzman R, Bryant M, Thompson AJ, Stoove MA, Snelling TL, Scott N, Spelman T, Anderson D, Richmond J, Howell J, Andric N, Dietze PM, Higgs P, Sacks-Davis R, Forbes AB, Hellard ME, Pedrana AE. Same-visit hepatitis C testing and treatment to accelerate cure among people who inject drugs (the QuickStart Study): a cluster randomised cross-over trial protocol. BMJ Open. 2024 Jul 2;14(7):e083502. doi: 10.1136/bmjopen-2023-083502.
PubMed 38960465
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same-visit Hepatitis C Testing and Treatment to Accelerate Cure Among People Who Inject Drugs: a Cluster Randomised Control Trial (The QuickStart Study)
- ClinicalTrials.gov ID
- NCT05016609
- Acronym / sponsor ID
- HREC/64731/Alfred-2020-217547
- Conditions
- Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health LtdUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 23 Aug 2021 (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.
The QuickStart study aims to assess the impact of three models of HCV care on HCV treatment uptake and cure among people who inject drugs. Rapid point-of-care (POC) HCV testing and test-and-treat strategies will be utilised in primary health care settings across Australia.
Detailed description
The QuickStart Study will explore models of point-of-care HCV testing and a same-day test and treat model to determine the impact of these models on HCV treatment initiation and cure. The study is a cluster cross-over randomised controlled trial. Sites are primary care services in Australia who provide services to people who inject drugs (PWID) and who routinely prescribe treatment for hepatitis C. Clinical services with a primary care practitioner and/or nurse experienced in providing DAA treatment to high numbers of PWID will be recruited to the study. A total of 30 services will be recruited with each service enrolling approximately 60 participants across an intervention and control period. Key participant eligibility include a history of injecting drug use and no previous treatment for HCV with direct acting antivirals.
Each site will participate in a control comparison period in addition to one of three interventions. The three interventions involve:
- A rapid HCV antibody test using a fingerprick sample and for anybody subsequently diagnosed with hepatitis C, management and treatment will be according to standard of care.
- A rapid HCV antibody test followed by a POC HCV RNA test for those who return a reactive antibody result. Both these will use a fingerprick sample and for anybody diagnosed with hepatitis C, management and treatment will be according to standard of care.
- A rapid HCV antibody test using a fingerprick sample and for participants who return a reactive result, an initial starter pack of DAA prior to a confirmed HCV RNA diagnosis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A cluster cross-over randomised controlled trial with cluster randomisation performed at the site level. Each site will be randomised to one of the three interventions and one standard of care period. All participants will receive the intervention or comparator that has been allocated to the service they present at.
| Arm | Type | Receives |
|---|---|---|
| POC HCV antibody group (Arm A) | Experimental | Device: OraQuick HCV Antibody test (OraSure Technologies, Inc)This group will receive POC HCV antibody testing via fingerprick using the OraQuick HCV antibody test (OraSure) in addition to the standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. Follow up and management of any treatment will be through usual standard-of-care. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire. |
| POC HCV RNA group (Arm B) | Experimental | Device: OraQuick HCV Antibody test (OraSure Technologies, Inc), Device: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)This group will receive POC HCV antibody testing using the OraQuick HCV antibody test. Participants in this group who return a positive POC HCV antibody result will receive POC HCV viral load testing via fingerstick using the Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) in addition to the standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. Follow up and management of any treatment will be through usual standard-of-care. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire. |
| Test and treat group (ArmC) | Experimental | Device: OraQuick HCV Antibody test (OraSure Technologies, Inc), Drug: Sofosbuvir/Velpatasvir (Gilead)This group will receive POC HCV antibody testing using the OraQuick HCV antibody test. Participants in this group who return a positive POC HCV antibody result will be provided a starter pack of HCV treatment (epclusa). POC tests results will be confirmed through standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. HCV RNA positive participants will continue treatment. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire. |
| Control | No intervention | –This group will receive the standard of care for HCV testing and treatment. Participants in this group will fill out a short behavioural questionnaire and a clinical questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- current or former PWID (i.e., injected drugs at least once)
- aged 18 years or over
- attending a participating PHC for any reason
- no previous treatment with DAAs for HCV
- failed interferon based treatment for HCV in the past (i.e., did not achieve cure)
Key exclusion criteria (4 listed)
- women known to be currently pregnant or who are breastfeeding
- individuals self-reporting to be currently engaged in treatment for HCV
- unable to provide informed consent
- tested for HCV in the past 3 months
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 |
|---|---|---|
| OraQuick HCV Antibody test (OraSure Technologies, Inc)The OraQuick HCV test is a point of care antibody test for detecting HCV antibodies in fingerstick blood. The test takes 20 minutes to provide a result. Appropriate pre- and post-test counselling will be provided to participants. | Device | POC HCV RNA group (Arm B), POC HCV antibody group (Arm A), Test and treat group (ArmC) |
| Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)Xpert® HCV VL Fingerstick is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human venous and capillary fingerstick EDTA whole blood. Only participants who return a reactive OraQuick HCV Antibody test will be offered the Xpert® HCV VL Fingerstick test. Appropriate pre- and post-test counselling will be provided to participants. | Device | POC HCV RNA group (Arm B) |
| Sofosbuvir/Velpatasvir (Gilead)Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir. | Drug | Test and treat group (ArmC) |
Primary outcome
HCV treatment
Time frame: Within 12 weeks of enrolment
The number of participants who start HCV treatment in each of the intervention arms (Arm A, Arm B or Arm C) within 12 weeks of enrolment, compared with standard care testing and treatment (Control Arm).
HCV cure
Time frame: HCV cure will be measured between 4 and 20 weeks post treatment completion.
The number of participants who achieve HCV cure in each of the intervention arms (Arm A, Arm B or Arm C), compared with standard care testing and treatment (Control Arm).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 40607684Heath K, Guzman R, Elsum I, Wade AJ, Allardice K, Kasza J, Bryant M, Thompson AJ, Stoove M, Snelling T, Scott N, Spelman T, Anderson DA, Richmond J, Howell J, Andric N, Dietze P, Higgs P, Sacks-Davis R, Forbes A, Hellard ME, Pedrana AE, Doyle JS. Balancing Efficiency and Accuracy in Hepatitis C Rapid Antibody Testing: Insights From a Cluster Randomised Crossover Trial. J Viral Hepat. 2025 Aug;32(8):e70043. doi: 10.1111/jvh.70043.
- Derived from this study: PubMed 38960465Doyle JS, Heath K, Elsum I, Douglass C, Wade A, Kasza J, Allardice K, Von Bibra S, Chan K, Camesella B, Guzman R, Bryant M, Thompson AJ, Stoove MA, Snelling TL, Scott N, Spelman T, Anderson D, Richmond J, Howell J, Andric N, Dietze PM, Higgs P, Sacks-Davis R, Forbes AB, Hellard ME, Pedrana AE. Same-visit hepatitis C testing and treatment to accelerate cure among people who inject drugs (the QuickStart Study): a cluster randomised cross-over trial protocol. BMJ Open. 2024 Jul 2;14(7):e083502. doi: 10.1136/bmjopen-2023-083502.
- Individual participant dataSharing planned: No. Requests for data sharing can be made to the principal investigator; further approval by the Human Research Ethics Committee may be necessary given the sensitive behaviour and risk information collected in the context of a trial of people who use drugs and hepatitis C testing.
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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.
Joseph Doyle, MBBS, PhD principal investigator
Burnet Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OraQuick HCV Antibody test (OraSure Technologies, Inc), Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) and Sofosbuvir/Velpatasvir (Gilead) in people with Hepatitis C, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 6 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caitlin Douglass, BHSc(Hons) (+61404707275, caitlin.douglass@burnet.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV treatment (time frame: Within 12 weeks of enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05016609, which also lists 2 linked publications.
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 13 Nov 2023.