NCT05016609

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2022-03-09
• Primary completion: 2024-04-01
• Completion: 2024-06-01
• First posted: 2021-08-23
• Last updated: 2023-11-13

Locations

6 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study
• FDA-regulated device study