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Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)

PHASE4RECRUITING

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.

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Study details:

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) 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.

B) 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. C) 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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Exclusion criteria

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-03-09

Primary completion: 2024-04-01

Study completion finish: 2024-06-01

Study type

HEALTH_SERVICES_RESEARCH

Phase

PHASE4

Trial ID

NCT05016609

Intervention or treatment

DEVICE: OraQuick HCV Antibody test (OraSure Technologies, Inc)

DEVICE: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)

DRUG: Sofosbuvir/Velpatasvir (Gilead)

Conditions

• Hepatitis C

Condition: Hepatitis C
DEVICE: OraQuick HCV Antibody test (OraSure Technologies, Inc) and other drugs
Clayton South, Victoria, Australia and more
Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Mediclinic Australia

Research sites nearby

Select from list below to view details:

Mediclinic Australia
Clayton South, Victoria, Australia
Innerspace
Collingwood, Victoria, Australia
Corio Community Health Centre
Corio, Victoria, Australia
Cohealth Fitzroy
Fitzroy, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: POC HCV antibody group (Arm A) 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.	DEVICE: 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.
EXPERIMENTAL: POC HCV RNA group (Arm B) 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.	DEVICE: 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.
EXPERIMENTAL: Test and treat group (ArmC) 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.	DEVICE: 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.
NO_INTERVENTION: Control 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.	Not specified

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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).	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).	HCV cure will be measured between 4 and 20 weeks post treatment completion.

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)