None listed
Conditions
Brief summary
This is a pilot feasibility study to evaluate mobile rapid point-of-care hepatitis C antibody and RNA testing and treatment initiation for individuals completing community correction orders, who are at high risk of viral hepatitis but currently cannot access prison-based hepatitis screening and treatment programs. This study will evaluate the feasibility, acceptability and efficacy of point-of-care fingerstick testing for hepatitis C antibodies and hepatitis C viral load, as well as rates of direct-acting antiviral (DAA) initiation (including same day hepatitis C testing and initiation of treatment) and treatment outcomes. A mobile clinic van fitted with medical equipment and staffed by a hepatitis clinical nurse consultants and peer mentor will attend community corrections facilities to recruit individuals attending these sites. Following recruitment, study personnel will conduct hepatitis C point-of-care testing, clinical assessments from the van, and initiate DAA therapy and discuss harm reduction strategies where appropriate. The study is a prospective cohort design recruiting consecutive participants at designated community correction sites over an 18 month period. Participants will be tested for hepatitis C exposure using a point of care antibody test. For participants who test positive for hepatitis C antibodies, current hepatitis C infection will be tested using rapid POC HCV VL fingerstick testing through the mobile van service. All participants who have current hepatitis C infection will be offered DAA treatment in line with the Australian consensus statement on the management of hepatitis C. Following completion of DAA therapy, participants will be monitored for an additional 4-12 weeks and offered hepatitis C point-of-care RNA PCR testing to confirm cure. The primary outcomes of the study are the feasibility of POC hepatitis C testing amongst the study population, DAA treatment initiation, uptake of same day hepatitis C testing and treatment initiation and likelihood of hepatitis C cure.
Interventions
The primary aim of this single-arm interventional study is to pilot the feasibility, acceptability and effectiveness of a nurse- and peer-led healthcare model which uses point-of-care hepatitis C antibody and RNA testing for screening individuals completing a community correction order, and likelihood of initiation of direct-acting antiviral (DAA) treatment in those who test positive for hepatitis C infection.
A mobile clinic van fitted with medical equipment and staffed by a hepatitis clinical
The primary aim of this single-arm interventional study is to pilot the feasibility, acceptability and effectiveness of a nurse- and peer-led healthcare model which uses point-of-care hepatitis C antibody and RNA testing for screening individuals completing a community correction order, and likelihood of initiation of direct-acting antiviral (DAA) treatment in those who test positive for hepatitis C infection. A mobile clinic van fitted with medical equipment and staffed by a hepatitis clinical nurse consultant and person with lived or living experience of hepatitis C, injecting drug use and/or criminal justice system involvement (‘peer mentor’) will attend community correction facilities to recruit individuals attending these sites. The clinic van will attend three community corrections sites in the Melbourne metropolitan area, three (3) days per week, rotating from each site every calendar month for at least 18 months. Following recruitment, study personnel will conduct hepatitis C point-of-care testing and clinical assessments from the van. Participants who test positive for hepatitis C infection will be assessed for treatment and initiate 8-12 week DAA therapy according to a hepatology Nurse Practitioner-directed decision-making algorithm, taking into account other medical considerations. Discussion of harm reduction strategies, including prevention of onward transmission and reinfection, as well as prevention of overdose, access to drug treatment support and other health resources will be initiated by the peer mentor. The following point-of-care rapid diagnostic devices will be used: • The INSTI HCV Antibody Test (bioLytical Laboratories Inc) is a class IV qualitative immunochromatographic assay for detection of IgM and IgG Antibodies to the hepatitis C virus in a clinical specimen of whole blood. A rapid hepatitis C blood testing kit is used to determine if someone has ever been infected with the hepatitis C virus. The INSTI HCV Antibody test has sensitivity of 100% and a specificity of 99.7% in clinical studies and Class IV medical device classification. • The SD Bioline; HCV rapid ICT Kit (Abbott Diagnostics Point of Care) is a qualitative immunochromatographic assay for detection of total antibodies to the hepatitis C virus in a clinical specimen of whole blood. This is a rapid test used in point-of-care analyses, to identify participants with antibody response to HCV. The SD Bioline; HCV rapid ICT Kit has sensitivity of 99.3% (95% CI: 97.9 - 99.8%) and specificity of 100% (95% CI: 99.7 - 100 %) and has Class IV medical device classification. • The Cepheid Xpert® HCV VL fingerstick assay is performed using a portable bench top GeneXpert platform which processes real-time PCR in a self-contained cartridge. The Xpert® HCV VL fingerstick assay has been validated for use with serum or plasma, and more recently whole blood collected via fingerstick sample, with excellent sensitivity (100%, 95% CI 93.9-100%) and specificity (100%, 95% CI 96.6-100%). Participants will first be screened for hepatitis C exposure using a point-of-care hepatitis C antibody test (either the INSTI HCV Antibody Test or SD Bioline; HCV rapid ICT Kit, determined by supply availability). These tests are performed using a fingerstick collection of 10-50µL of capillary blood using a pipette and provides a qualitative result available in 1 minute (INSTI HCV Antibody Test) or 5-20 minutes (SD Bioline; HCV rapid ICT Kit). Participants who test positive for hepatitis C antibodies will be reflex tested for current hepatitis C infection using the Cepheid Xpert® HCV VL Fingerstick assay. Participants who report previous or current infection will be tested directly for hepatitis C RNA (no antibody test). Participants will be engaged for a minimum of approximately 15 minutes (in the event of a negative antibody test), up to a maximum of approximately 90 minutes (in the event of positive antibody and RNA tests, and agreement with proceeding to a clinical assessment for hepatitis C treatment). Participants who commence DAA treatment for hepatitis C infection will be contacted at four (4) and eight (8) weeks following commencement for clinical review, medication adherence, and social/emotional support. With participants consent, pharmaceutical benefits scheme records will be accessed, in order to track participants who are uncontactable (e.g., in the case of homelessness or absence of a mobile phone).
Sponsors
St Vincent's Hospital Melbourne (Limited)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged at least 18 years; 2. Consenting to point-of-care fingerstick testing for hepatitis C; 3. Consent to provide full name, date of birth, contact details, Medicare number and general practitioner details (if available); 4. Not currently engaged in treatment for hepatitis C infection;
Exclusion criteria
1.. Unable or unwilling to undergo point-of-care hepatitis C RNA testing. 2. Unable or unwilling to provide informed consent There are no other exclusion criteria for testing for hepatitis C infection, however there may be contraindication or caution to hepatitis C DAA treatment including: a. receiving medications which are contraindicated to the co-administration of DAAs or at risk of significant drug-drug interaction; b. pregnant or breastfeeding at the time of commenced of DAA therapy; c. Individuals with decompensated chronic liver disease These individuals will be referred to St Vincent’s Hospital for specialist consultation review.
Outcome results
None listed