Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001043628
Ethics application status
Approved
Date submitted
30/08/2023
Date registered
27/09/2023
Date last updated
27/09/2023
Date data sharing statement initially provided
27/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
C No More: Mobile hepatitis C testing and treatment for people on community corrections orders
Scientific title
A pilot single-arm nurse and peer-led mobile hepatitis C testing and treatment clinic for people on community corrections orders, using rapid point-of-care testing technologies.
Secondary ID [1] 310499 0
Nil
Universal Trial Number (UTN)
U1111-1297-2940
Trial acronym
C No More
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hepatitis C 331291 0
Condition category
Condition code
Infection 328047 328047 0 0
Other infectious diseases
Public Health 328048 328048 0 0
Health service research
Oral and Gastrointestinal 328257 328257 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 326888 0
Treatment: Devices
Intervention code [2] 326890 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335921 0
Proportion of people approached who were tested for hepatitis C using point-of-care testing technologies, captured through a daily log kept by the study team.
Timepoint [1] 335921 0
18 months post intervention commencement
Primary outcome [2] 335922 0
Proportion of participants testing positive for current hepatitis C infection who are initiated on direct-acting antiviral treatment, captured through clinical data collected on REDCap by the study nurse.
Timepoint [2] 335922 0
24 months post-intervention commencement
Secondary outcome [1] 426153 0
The proportion of participants who commenced DAA treatment on the same day as hepatitis C diagnosis via point-of-care testing, captured through timestamped REDCap data entry by the study team.
Timepoint [1] 426153 0
18 months post intervention commencement
Secondary outcome [2] 426154 0
The proportion of participants initiating hepatitis C DAA treatment who reach SVR4 (sustained virological response at least 4 weeks following completion of treatment), captured through clinical data collected on REDCap by the study nurse.
Timepoint [2] 426154 0
24 months post intervention commencement
Secondary outcome [3] 426155 0
The acceptability of point-of-care hepatitis C testing amongst the study population measured using study-specific quantitative (30 minute interviewer-administered, face-to-face survey including patient satisfaction likert scales), and qualitative assessments (45 minute in-depth, open-ended, face-to-face interview).
Timepoint [3] 426155 0
Quantitative survey conducted immediately following receipt of testing, or at a later date depending on participant's availability.

Qualitative survey conducted within 3 months of offer of testing or completion of treatment.
Secondary outcome [4] 426890 0
The proportion of participants who complete hepatitis C DAA treatment, captured through clinical data collected on REDCap by the study nurse.
Timepoint [4] 426890 0
24 months post-intervention commencement
Secondary outcome [5] 426891 0
Acceptability of the mobile nurse- and peer-led model of care amongst the study population and project staff, assessed by qualitative assessments (45 minute in-depth, open-ended, face-to-face interview with study participants) and review of study weekly meeting minutes.
Timepoint [5] 426891 0
18 months post intervention commencement
Secondary outcome [6] 426892 0
The average time between hepatitis C diagnosis and treatment initiation, measured using date of diagnosis and date of prescription dispensing, captured through testing timestamp on REDCap at the time of consent to participate, and PBS records,
Timepoint [6] 426892 0
18 months post intervention commencement
Secondary outcome [7] 426893 0
The proportion of participants initiating treatment who experience treatment related adverse events (e.g., headache, fatigue, nausea, gastrointestinal upset and unconjugated hyperbilirubinemia). Mild adverse events will be collected via study-specific questionnaires and telephone review, moderate adverse events will be assessed through clinical examination.
Timepoint [7] 426893 0
24 months post-intervention commencement
Secondary outcome [8] 426894 0
The proportion of participants completing a community corrections order versus other community members who access the clinical service, captured via quantitative surveys administered on REDCap, and verified by linkage to Corrections Victoria records.
Timepoint [8] 426894 0
24 months following intervention commencement
Secondary outcome [9] 426895 0
Description of the population accessing hepatitis C POC testing at the mobile van, including sociodemographics, risk factors for hepatitis C infection, prior diagnosis and treatment of hepatitis C infection, drug use and protective behaviours. Data captured via quantitative surveys conducted with study participants.
Timepoint [9] 426895 0
18 months following intervention commencement
Secondary outcome [10] 426898 0
Proportion of participants diagnosed with hepatitis C who have APRI >1.0 and/or cirrhosis (based on FibroScan® findings, captured from clinical investigations and recorded in REDCap by the study nurse.
Timepoint [10] 426898 0
18 months post-intervention commencement
Secondary outcome [11] 426899 0
Hepatitis C relapse and reinfection rates will be assessed as a secondary composite outcome among the study population who report previous treatment, captured through quantitative surveys recorded on REDCap by the study nurse and verified by the participants previous treatment provider. Relapse and reinfection will also be assessed at the SVR timepoint for participants treated through the C No More study.
Timepoint [11] 426899 0
24 months post-intervention commencement

Eligibility
Key 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;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Given this is a pilot study for the implementation of mobile point-of-care testing, interpretation of findings will be primarily descriptive.
The proportion of individuals commencing HCV treatment will be defined as the number of participants who received at least one dose of HCV treatment amongst all study participants who returned a positive HCV RNA result during the study. SVR4+ will be determined either using the Xpert HCV VL Fingerstick test or standard of care qualitative HCV RNA by venepuncture in those that have undergone HCV treatment. Both intention to treat and per-protocol analyses will be included when assessing outcomes for HCV treatment.

Categorical data will be presented as frequencies and continuous data will be presented as medians with interquartile range. Logistic regression will be used to identify clinical, sociodemographic and behavioural predictors (age, Aboriginal and/or Torres Strait islander status, gender, housing stability, hepatitis C risk behaviours, treatment regimen and drug and alcohol use) of a positive diagnosis and predictors of linkage to treatment. Comparisons will be made using Pearson’s chi2/fisher exact for categorical data and Mann-Whitney U test for continuous variables. Two tailed tests of significance at p<0.05 will be used in all inferential tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/09/2023
Date of last participant enrolment
Anticipated
20/03/2025
Actual
Date of last data collection
Anticipated
12/09/2025
Actual
Sample size
Target
600
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 41284 0
3030 - Werribee
Recruitment postcode(s) [2] 41283 0
3047 - Broadmeadows
Recruitment postcode(s) [3] 41282 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 314672 0
Commercial sector/Industry
Name [1] 314672 0
Gilead Sciences
Country [1] 314672 0
Australia
Funding source category [2] 314701 0
Hospital
Name [2] 314701 0
St Vincent's Hospital Melbourne
Country [2] 314701 0
Australia
Funding source category [3] 314702 0
Government body
Name [3] 314702 0
NHMRC Hepatitis C Program Grant (1132902)
Country [3] 314702 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne (Limited)
Address
35 Victoria Pde, Fitzroy, VIC, 3065
Country
Australia
Secondary sponsor category [1] 316758 0
None
Name [1] 316758 0
Address [1] 316758 0
Country [1] 316758 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313691 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 313691 0
35 Victoria Pde, Fitzroy, VIC, 3065
Ethics committee country [1] 313691 0
Australia
Date submitted for ethics approval [1] 313691 0
25/07/2023
Approval date [1] 313691 0
11/09/2023
Ethics approval number [1] 313691 0
025/23

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129030 0
Prof Alexander Thompson
Address 129030 0
St Vincent's Hospital Melbourne, 35 Victoria Pde, Fitzroy, VIC 3065
Country 129030 0
Australia
Phone 129030 0
+613 9282 3581
Fax 129030 0
Email 129030 0
rebecca.winter@burnet.edu.au
Contact person for public queries
Name 129031 0
Dr Rebecca Winter
Address 129031 0
Burnet Institute, 85 Commercial Road, Melbourne, Victoria, 3004
Country 129031 0
Australia
Phone 129031 0
+613 9282 2111
Fax 129031 0
Email 129031 0
rebecca.winter@burnet.edu.au
Contact person for scientific queries
Name 129032 0
A/Prof Jacinta Holmes
Address 129032 0
St Vincent's Hospital Melbourne, 35 Victoria Pde, Fitzroy, VIC, 3065
Country 129032 0
Australia
Phone 129032 0
+61 3 9281 3590
Fax 129032 0
Email 129032 0
jacinta.holmes@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20177Informed consent form    386493-(Uploaded-30-08-2023-11-17-44)-Study-related document.docx



Results publications and other study-related documents

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