None listed
Conditions
Brief summary
A key barrier to hepatitis C (HCV) diagnosis and treatment is the multi-stage process of conventional HCV testing as patients require multiple visits to pathology services and healthcare providers to obtain a HCV antibody test, then a HCV RNA test, receive the result and finally be linked into care. This novel study aims to scale up HCV screening in the community by providing HCV point-of-care (POC) testing, liver assessment and direct referral into treatment at the priority settings of mental health, prisons and alcohol & other drugs (AOD) services. The study will investigate the benefit of providing POC HCV diagnostic testing using SD Bioline fingerstick antibody (Ab) assay and Cepheid fingerstick HCV RNA for participants who return a positive HCV Ab result. Providing same day test results and referral for treatment in one visit addresses a major barrier to HCV treatment uptake, particularly in people at high risk of HCV infection such as people who inject drugs (PWIDs).
Interventions
This is a novel feasibility study introducing Point of Care (POC) testing for HCV in clinics with high caseload of people at risk of HCV infection, in particular people who inject drugs (PWID). There will be concurrent activation of 3 sites enrolling over an approximate 12 month period, each from a mental health, prison & AOD setting.
POC HCV testing will be performed or overseen by PROMPt project staff in conjunction with peer workers and clinic staff who will provide fingerstick tests to part
This is a novel feasibility study introducing Point of Care (POC) testing for HCV in clinics with high caseload of people at risk of HCV infection, in particular people who inject drugs (PWID). There will be concurrent activation of 3 sites enrolling over an approximate 12 month period, each from a mental health, prison & AOD setting. POC HCV testing will be performed or overseen by PROMPt project staff in conjunction with peer workers and clinic staff who will provide fingerstick tests to participants, read the result and counsel the particiapnt about their result. Any person performing the test will undergo full training in pre & post test counselling and testing procedures. The SD Bioline HCV POC fingerstick test will be used to detect antibodies to HCV in human whole blood, the test takes 20 minutes. Positive tests will then be reflexed to the GeneXpert HCV viral load POC fingerstick to perform a quantitative RNA assay that will provide a result from whole blood in 60 minutes. Project staff, including peer support workers where possible will provide HCV education, pre/post test counselling and linkage to care as appropriate with the support of the lead clinician within each domain and Viral Hepatitis nurses specific to the local health network. This will all be done verbally and will take approximately 30 minutes. Study participants will not receive treatment as part of this study.
Sponsors
Eliminate C Australia
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants will be recruited from mental health, AOD and prison study sites. An opt-out approach to consent will be employed. Inclusion criteria 1) Aged > 18 years 2) Able to provide voluntary informed consent 3) Not currently engaged in care for the treatment of hepatitis C infection.
Exclusion criteria
Exclusion criteria 1) Unable or unwilling to provide informed consent or abide by the requirements of the study.
Outcome results
None listed