Hepatitis C
Conditions
Brief summary
The study aims to assess the impact of models of HCV care on HCV testing, treatment uptake and cure within Cairns. Point of care testing for HCV , with test and treat strategies will be offered within a primary care service.
Detailed description
Available testing and treatment data will be explored pre and post the intervention period of the project within Cairns Hinterland health services that provide hepatitis C care. Test and treat strategies of the project will include: Part A: Same day test and treat clinical trial. The study will explore a 'same day test and treat' model to determine the impact on HCV treatment initiation and cure within a primary care service that recognises that they see people at risk of hepatitis C that are transient, and struggle to return to a care provider to engage in hepatitis C testing and care. 1. HCV RNA point of care (POC) testing 2. Epclusa (Sofosbuvir/Velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve HCV RNA result from the POC test. Part B: Refresher and clinic in reach support work Primary care service/ General practitioner education and training \ 1 hour in-person training for all clinic staff on hepatitis C testing, treatment, retention in HCV care cascade. Part C: Services evaluation with incentive and peer intervention in HCV care cascade.
Interventions
DEVICEXpert 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. Appropriate pre and post testing counselling will be provided to participants.
DRUGEpclusa 400Mg-100Mg Tablet
Same day HCV test and treatment
OTHERStandard of care
Clinical services will receive additional education and have the option of providing incentives to attendees of service.
Sponsors
Cairns Hinterland Health Hospital and Health Services
The University of Queensland
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The model will permit all interventions to be explored for their impact on testing and treatment numbers in the HCV care cascade
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* attending primary health care service of CHHS aged 18 years or over
Exclusion criteria
only for intervention arm test and treat * Known to have hepatitis B or HIV infection * Known to have cirrhosis * Previous treatment with direct acting antivirals * Previously received interferon-based hepatitis C treatment that did not work * Women that are pregnant or breastfeeding * Already receiving hepatitis C treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HCV testing | 12 months | The number of participants who receive HCV testing in each of the arms |
| HCV treatment | 12 months | The number of participants who start HCV treatment in each of the arms |
Countries
Australia
Outcome results
None listed