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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Same-visit Hepatitis C Testing and Treatment to Accelerate Cure Among People Who Inject Drugs: a Cluster Randomised Control Trial (The QuickStart Study)

Conditions
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Hepatitis C

Intervention / Treatment
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* Device: OraQuick HCV Antibody test (OraSure Technologies, Inc)
* Device: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
* Drug: Sofosbuvir/Velpatasvir (Gilead)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A cluster cross-over randomised controlled trial with cluster randomisation performed at the site level. Each site will be randomised to one of the three interventions and one standard of care period. All participants will receive the intervention or comparator that has been allocated to the service they present at.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POC HCV antibody group (Arm A)<br>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)<br>* 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.<br>|
| Experimental: POC HCV RNA group (Arm B)<br>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)<br>* 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.<br>Device: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)<br>* 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.<br>|
| Experimental: Test and treat group (ArmC)<br>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)<br>* 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.<br>Drug: Sofosbuvir/Velpatasvir (Gilead)<br>* Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir.<br>|
| No Intervention: Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. |