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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04510246




Registration number
NCT04510246
Ethics application status
Date submitted
10/08/2020
Date registered
12/08/2020

Titles & IDs
Public title
Link Hepatitis C Notifications to Treatment in Tasmania
Scientific title
A Randomised Controlled Trial of Active Case Management to Link Hepatitis C Notifications to Hepatitis C Treatment in Tasmania
Secondary ID [1] 0 0
Tas RCT HCV Notifications
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 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
BEHAVIORAL - Enhanced case management

Experimental: Intervention - Practitioners randomised to the intervention arm will receive the standard of care surveillance letter if the notification is new. Both new and repeat notifications will receive further enhanced case support during the project if required. Support can be provided at the first phone call, or if accepted and required, in a 12-week period during which the DoH health care worker can do follow-up calls with the GP or directly with the patient to inform the patient and enhance linkage back to their GP. At the end of the 12-week period, a follow-up call we be carried out for the project evaluation.

No intervention: Control - All practitioners randomised to this arm will be contacted by telephone approximately 12 weeks after an HCV notification has been made from the laboratory to the Department of Health.This is not current standard practise and will be performed by the DoH HCV health worker for the project evaluation purpose. At this phone call consent will be sought for the GP to provide information on their clinical management of the notified patient. The details of the clinical management survey are provided as Appendix B. Details provided or missing from the standard DoH surveillance form would be confirmed with the GP at this phone call. Three attempts will be made to contact the practitioner to complete the survey within a 30-day period before they are determined to be unable to be contacted.


BEHAVIORAL: Enhanced case management
The health care worker will offer support to the GP for all aspects of the cascade of hepatitis C care including:

* Further testing advice
* Awareness that treatment can be prescribed by the general practitioner
* Conducting pre-treatment work-up assessment
* DAA prescription guidelines, including linkage to specialist consultation
* Providing treatment support
* Advising on testing process for cure
* Advising on post-cure management including methods of follow-up to manage risks (e.g. harm minimisation, reducing re-infection risk, opioid substitution therapy)
* Linking GP to resources for patients with cirrhosis or other concerns to specialist support for ongoing management.

The GP will be offered the option of the DoH specialist to contact the patient directly with the GP's consent to notify them of their result and to educate them on testing and treatment options and referral back to their GP.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of cases notified with hepatitis C who commence hepatitis C treatment
Timepoint [1] 0 0
The study follow up period is 12 weeks
Secondary outcome [1] 0 0
Proportion of people diagnosed with hepatitis C with a documented HCV RNA test result
Timepoint [1] 0 0
The study follow up period is 12 weeks
Secondary outcome [2] 0 0
Proportion of people diagnosed with hepatitis C completing treatment work-up blood tests
Timepoint [2] 0 0
The study follow up period is 12 weeks
Secondary outcome [3] 0 0
Proportion of people diagnosed with hepatitis C completing an appropriate course of hepatitis C treatment as prescribed
Timepoint [3] 0 0
The study follow up period is 12 weeks

Eligibility
Key inclusion criteria
* General Practitioners (GP) who have requested a hepatitis C test that leads to new or repeat notification to the Tasmanian Department of Health
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Not based in Tasmania
* Practitioner from correctional service
* Specialist
* Nurse practitioner who initiated test
* Sexual health service doctor
* Family planning
* Trainee

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/03/2022
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Tasmanian Department of Health - Hobart
Recruitment postcode(s) [1] 0 0
7001 - Hobart

Funding & Sponsors
Primary sponsor type
Other
Name
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Department of Health and Human Services
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Joseph Doyle, PhD
Address 0 0
Country 0 0
Phone 0 0
+613 9076 5436
Fax 0 0
Email 0 0
joseph.doyle@burnet.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data will be captured in RedCap and is de-identifiable and will be shared as a data file from the data capturing tool.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Within 6 months of study completion
Available to whom?
Full data file will be available to be shared after study completion.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04510246