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

Phase 4

Recruiting

• Conditions: Hepatitis C
• Interventions: Device: OraQuick HCV Antibody test (OraSure Technologies, Inc); Device: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid); Drug: Sofosbuvir/Velpatasvir (Gilead)

• Registration Number: NCT05016609
• Lead Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Brief 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.

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 Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-23
• Study Start: 2022-03-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-04
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
POC HCV antibody group (Arm A)	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)	OraQuick HCV Antibody test (OraSure Technologies, Inc)	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.
POC HCV RNA group (Arm B)	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)	OraQuick HCV Antibody test (OraSure Technologies, Inc)	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.
Test and treat group (ArmC)	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.

Primary Outcome Measures

Name	Time	Method
HCV treatment	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	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).

Trial Locations

Locations (6)

Corio Community Health Centre; 🇦🇺 Corio, Victoria, Australia

Cohealth Fitzroy; 🇦🇺 Fitzroy, Victoria, Australia

Mediclinic Australia; 🇦🇺 Clayton South, Victoria, Australia

Homeless Healthcare; 🇦🇺 Highgate, Western Australia, Australia

Cockburn Wellbeing; 🇦🇺 Success, Western Australia, Australia

Innerspace; 🇦🇺 Collingwood, Victoria, Australia