Same-visit Hepatitis C Testing and Treatment to Accelerate Cure Among People Who Inject Drugs: a Cluster Randomised Control Trial (The QuickStart Study)
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Australia
Mediclinic Australia
RECRUITING
Clayton South
Innerspace
RECRUITING
Collingwood
Corio Community Health Centre
RECRUITING
Corio
Cohealth Fitzroy
RECRUITING
Fitzroy
Homeless Healthcare
RECRUITING
Highgate
Cockburn Wellbeing
RECRUITING
Success
Contact Information
Primary
Caitlin Douglass, BHSc(Hons)
caitlin.douglass@burnet.edu.au
+61404707275
Backup
Mellissa Bryant
mellissa.bryant@burnet.edu.au
+61392822162
Time Frame
Start Date: 2022-03-09
Estimated Completion Date: 2024-06
Participants
Target number of participants: 1800
Treatments
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.
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Macfarlane Burnet Institute for Medical Research and Public Health Ltd