None listed
Conditions
Brief summary
The aims of this study are to evalute the uptake and acceptability of point fo care testing for hepatitis C using the Xpert Hepatitis C (HCV) Viral Load (VL) Fingerstick test, as compared to standard of care HCV testing in persons who inject drugs presenting to the medically supervised injecting room in Richmond, Victoria. We also seek to evaluate if point of care testing increases the rates of initiation of HCV treatment. Participants will be those persons over the age of 18 years who inject drugs that visit the medically supervised injecting room in Richmond, Victoria. The study will be a time series design, with two arms, conducted over ten months. The recruitment phase will be a total of four months, with each arm (standard of care, point of care) recruiting for a consecutive period of two months. Participants recruited in the first two months (months 1-2) will undergo standard of care testing for HCV. Participants recruited in the subsequent two months (months 3-4) will undergo point of care testing with Xpert HCV VL Fingerstick. Participants who return a positive HCV RNA result, suggestive of chronic hepatitis C infection, will be offered treatment with direct acting antiviral therapy. Participants will be followed up throughout the treatment course at four-weekly intervals, at end of treatment and at 12 weeks post treatment completion to assess for sustained virological response (SVR12). Participants will also complete questionnaires at enrolment, following HCV testing and at each follow up visit to assess acceptability of point of care testing, as compared to standard of care testing.
Interventions
Study Design: Time series, recruiting consecutive patients over four months. In the first two months (months 1-2), patients will be assigned to the standard of care testing or comparator arm (Arm A). In the subsequent two months (months 3-4), patients will be assigned to the point of care testing or intervention arm (Arm B).
All participants with a positive HCV RNA result will be offered treatment either at the initial visit (if result available) or a later date on a subsequent visit to the med
Study Design: Time series, recruiting consecutive patients over four months. In the first two months (months 1-2), patients will be assigned to the standard of care testing or comparator arm (Arm A). In the subsequent two months (months 3-4), patients will be assigned to the point of care testing or intervention arm (Arm B). All participants with a positive HCV RNA result will be offered treatment either at the initial visit (if result available) or a later date on a subsequent visit to the medically supervised injecting room once this result is available. The primary outcomes will be to compare the uptake and acceptability of point of care testing to the standard of care model that exists at present, and the influence this has on treatment uptake/early initiation of treatment. The primary intervention involves point of care testing using the Cepheid Xpert HCV VL Fingerstick test. The Cepheid Xpert HCV VL test is run on the Cepheid GeneXpert platform, which is a bench top machine that performs real-time polymerase chain reaction (PCR) in a self-contained cartridge to provide a HCV RNA result within 60 minutes. It is done via fingerpick and only requires 100uL of capillary blood for a test to be run. The equipment required includes a lancet for fingerstick, minivettes 100ul to collect blood sample and transfer to cartridges, HCV VL Fingerstick cartridges and a GeneXpert 4 module system. The testing is quick, easy and will carried out by trained members of the study team (clinical nurse, integrated hepatitis nurse, medical practitioners). The Cepheid Xpert HCV VL Fingerstick test was been shown to have both a sensitivity and specificity of up to 100%. As the test is highly accurate and is performed in a standardised manner, no specific monitoring of the fidelity of the intervention is planned. The intervention will be delivered after recruitment and consent is gained from people who inject drugs that are attending a medically supervised injecting room in Melbourne, Victoria.
Sponsors
Gastroenterology Department, St Vincent's Hospital Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Aged greater than or equal to 18 years; - Present to the medically supervised injecting room during the recruitment phase of the study; - Able to provide written informed consent; - Consent to provide full name, contact details and Medicare number; - Consent to multiple visits and to completion of questionnaires; - Consent to blood sample for storage at pre-specified time points during the study; - Not currently engaged in care for treatment of hepatitis C infection, hepatitis B or HIV; - Fulfills study criteria for hepatitis C diagnosis to initiate treatment.
Exclusion criteria
- Pregnant or breastfeeding at time of commencement of hepatitis C antiviral treatment; - Clinical evidence of decompensated cirrhosis; - Diagnosed and/or undergoing treatment for hepatocellular carcinoma; - Awaiting liver transplantation; - Currently engaged in care for treatment of hepatitis C infection, hepatitis B infection or HIV; - Unable or unwilling to present to pick up ongoing DAA supply for treatment (four weekly basis); - Receiving medications which are contra-indicated to co-administration of direct acting antiviral's or at risk of significant drug-drug interactions; - Clients who are first time presenters or users of the medically supervised injecting room - Clients who receive a clinical intervention for overdose whilst using the supervised injecting drug room after initially consenting to participate; - Evidence of any condition, therapy, laboratory abnormality or other circumstance (current or prior) that may confound the study’s results, or interfere with participation for the full duration of the study, such that it is not in the best interest of the participant.
Outcome results
None listed