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

Hepatitis C Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05016609
• Other study ID #: HREC/64731/Alfred-2020-217547
• Status: Recruiting
• Phase: Phase 4
• Start date: March 9, 2022
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
• Contact: Caitlin Douglass, BHSc(Hons)
• Phone: +61404707275
• Email: caitlin.douglass[@]burnet.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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.
• 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.

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

Locations

Country	Name	City	State
Australia	Mediclinic Australia	Clayton South	Victoria
Australia	Innerspace	Collingwood	Victoria
Australia	Corio Community Health Centre	Corio	Victoria
Australia	Cohealth Fitzroy	Fitzroy	Victoria
Australia	Homeless Healthcare	Highgate	Western Australia
Australia	Cockburn Wellbeing	Success	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.