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

November 9, 2023 updated by: Macfarlane Burnet Institute for Medical Research and Public Health Ltd

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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) 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.

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Clayton South, Victoria, Australia, 3168
        • Recruiting
        • Mediclinic Australia
        • Contact:
        • Principal Investigator:
          • Ernesto Andrada
      • Collingwood, Victoria, Australia, 3066
      • Corio, Victoria, Australia, 3214
        • Recruiting
        • Corio Community Health Centre
        • Contact:
        • Principal Investigator:
          • Amanda Wade
      • Fitzroy, Victoria, Australia, 3065.
    • Western Australia
      • Highgate, Western Australia, Australia, 6003
        • Recruiting
        • Homeless Healthcare
        • Contact:
        • Principal Investigator:
          • Andrew Davies
      • Success, Western Australia, Australia, 6164
        • Recruiting
        • Cockburn Wellbeing
        • Contact:
        • Principal Investigator:
          • Calum Ross

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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.
Device: 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.
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.
Drug: Sofosbuvir/Velpatasvir (Gilead)
Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir.
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 Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 12 weeks of enrolment
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).
HCV cure will be measured between 4 and 20 weeks post treatment completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Investigators

  • Principal Investigator: Joseph Doyle, MBBS, PhD, Burnet Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 23, 2021

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC/64731/Alfred-2020-217547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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