Clinical trial NCT05016609: Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hepatitis C
Lead sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: HCV treatment
timeFrame: Within 12 weeks of enrolment
measure: HCV cure
timeFrame: HCV cure will be measured between 4 and 20 weeks post treatment completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Clayton South
country: Australia
facility: Mediclinic Australia
state: Victoria
city: Collingwood
country: Australia
facility: Innerspace
state: Victoria
city: Corio
country: Australia
facility: Corio Community Health Centre
state: Victoria
city: Fitzroy
country: Australia
facility: Cohealth Fitzroy
state: Victoria
city: Highgate
country: Australia
facility: Homeless Healthcare
state: Western Australia
city: Success
country: Australia
facility: Cockburn Wellbeing
state: Western Australia
Study officials:
affiliation: Burnet Institute
name: Joseph Doyle, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: