OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

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

PHASE4UNKNOWN

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.

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.

Eligibility criteria

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

Inclusion criteria

  1. current or former PWID (i.e., injected drugs at least once)
  2. aged 18 years or over
  3. attending a participating PHC for any reason
  4. no previous treatment with DAAs for HCV
  5. failed interferon based treatment for HCV in the past (i.e., did not achieve cure)
  6. Medicare eligible
  7. able to speak and understand English

Exclusion criteria

  1. women known to be currently pregnant or who are breastfeeding
  2. individuals self-reporting to be currently engaged in treatment for HCV
  3. unable to provide informed consent
  4. tested for HCV in the past 3 months

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

HEALTH_SERVICES_RESEARCH

phase

Phase

    PHASE4

trial

Study 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

Save

Share

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

Research sites nearby

Closest Location:

Mediclinic Australia

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

Loading map...

Who is running the clinical trial?

MBIfMRaPHL

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

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/ArmIntervention/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)
    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), Device: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
      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), Drug: Sofosbuvir/Velpatasvir (Gilead)
        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.

          What is the study measuring?

          Primary Outcome

          MeasureDescriptionTime Frame
          HCV treatmentThe 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 cureThe 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

          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)

          Other trials to consider

          Loading suggested trials...

          Top searched conditions

          Breast CancerLung CancerType 2 DiabetesDermatitisAlzheimersParkinsonsLupusCrohn’s DiseaseAsthmaHypertensionCOPDMultiple SclerosisOsteoarthritisHIV/AIDSPsoriasisStrokeObesityProstate CancerDepressionCardiovascular