A Phase 4 interventional study of OraQuick HCV Antibody test (OraSure Technologies, Inc) and Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) in Hepatitis C, sponsored by Macfarlane Burnet Institute for Medical Research and Public Health Ltd. Status unknown at 6 sites in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Macfarlane Burnet Institute for Medical Research and Public Health Ltd · Phase 4, Interventional, and Health services research
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.
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.
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's planned enrollment of 1,800 is above the median of 79 across 1,660 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Macfarlane Burnet Institute for Medical Research and Public Health Ltd is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
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)
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)
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.
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 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 pages: Sofosbuvir · Velpatasvir
Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir.
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).
Time frame: Within 12 weeks of enrolment
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).
Time frame: HCV cure will be measured between 4 and 20 weeks post treatment completion.
Plan to share: No — 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.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Sofosbuvir · Velpatasvir
Macfarlane Burnet Institute for Medical Research and Public Health Ltd