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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04061551




Registration number
NCT04061551
Ethics application status
Date submitted
4/06/2019
Date registered
20/08/2019
Date last updated
24/08/2021

Titles & IDs
Public title
Eliminate Hepatitis C/EC Partnership Evaluation Protocol
Scientific title
Eliminate Hepatitis C/EC Partnership Evaluation Protocol
Secondary ID [1] 0 0
HREC/16/Alfred/164
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Chronic Hepatitis c 0 0
Hepatitis C, Chronic 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
Other interventions - EC clinic support - whole of practice interventions delivery through nurse-led model

Experimental: EC Clinic Support - Whole of practice interventions delivery through nurse-led model


Other interventions: EC clinic support - whole of practice interventions delivery through nurse-led model
The primary interventions will be delivered through a team of nurses, an evaluation team and practice support team that will be working with each of the services to improved Hepatitis C service delivery.

The EC project team will predominantly be involved in working with providers and staff at EC sites to implement key interventions that have been collated into a Primary Care Practice Toolkit, which cover three domains; patient support, provider support and practice Support. The toolkit is designed to be an educational and implementation resource that the nursing team will support services to deliver.

* Patient support to reduce the impact of hepatitis C and other blood borne viruses
* Provider support to reduce the impact of hepatitis C and other blood borne viruses
* Practice support to reduce the impact of hepatitis C and other blood borne viruses
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Uptake of treatment amongst PWID
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Treatment effectiveness relative to tertiary care services
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Costs of scaling up treatment for PWID
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Changes in HCV prevalence and incidence in Victoria
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Projected impact on HCV elimination targets
Timepoint [4] 0 0
5 years

Eligibility
Key inclusion criteria
The level of recruitment is clinics rather than individuals. Eligible clinics are those with a high HCV caseload, with a focus on drug and alcohol community clinics and general practitioners.

Eligibility criteria for individuals providing information in the form of interviews will be:

* 18 years of age or older; AND
* Willing and able to provide informed, written consent to participate; AND
* Either of:

* staff of a participating EC site who are involved in hepatitis C care; OR
* clients of a participating EC site who attend the site for screening and management of hepatitis C.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Burnet Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

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
Other
Name [1] 0 0
Burnet Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Alfred
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
St Vincent's Hospital Melbourne
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
HepatitisVictoria
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Harm Reduction Australia
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Victoria State Government
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Commercial sector/industry
Name [7] 0 0
Gilead Sciences
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
National Health and Medical Research Council, Australia
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The Eliminate Hepatitis C (EC) Partnership project is a multi-site, multi-year project aiming to enhance and extend hepatitis C virus (HCV) care and treatment among people who inject drugs (PWID) through nurse-led models of care in the community and the prison system. The project will implement and evaluate a health service intervention to enhance HCV response by improving health promotion, offering training and education to service providers, streamlining clinical pathways, utilising data systems and surveillance and implementing the results of ongoing research and evaluation.

Health services data will be used to assess the impact of the EC nurse-led support, to enhance the clinical pathway and increase HCV testing, linkage to care and treatment uptake in community and prison settings. This will include provider and client interviews and a sentinel surveillance system (ACCESS) that will track and monitor impact indicators including HCV testing, linkage to care and treatment uptake at the service and population level.

Overall, evaluation data will be used to monitor the uptake of HCV treatment in PWID, monitor the effectiveness of community- and prison-based treatment program and assess the cost and feasibility of treating \>1160 PWID in community-/prison-based program and assess changes in HCV prevalence in Victoria and modelling the impact of treating PWID to inform HCV elimination models in Australia and globally.
Trial website
https://clinicaltrials.gov/study/NCT04061551
Trial related presentations / publications
Scott N, McBryde ES, Thompson A, Doyle JS, Hellard ME. Treatment scale-up to achieve global HCV incidence and mortality elimination targets: a cost-effectiveness model. Gut. 2017 Aug;66(8):1507-1515. doi: 10.1136/gutjnl-2016-311504. Epub 2016 Apr 12.
Scott N, Doyle JS, Wilson DP, Wade A, Howell J, Pedrana A, Thompson A, Hellard ME. Reaching hepatitis C virus elimination targets requires health system interventions to enhance the care cascade. Int J Drug Policy. 2017 Sep;47:107-116. doi: 10.1016/j.drugpo.2017.07.006. Epub 2017 Aug 7.
Doyle JS, Scott N, Sacks-Davis R, Pedrana AE, Thompson AJ, Hellard ME; Eliminate Hepatitis C Partnership. Treatment access is only the first step to hepatitis C elimination: experience of universal anti-viral treatment access in Australia. Aliment Pharmacol Ther. 2019 May;49(9):1223-1229. doi: 10.1111/apt.15210. Epub 2019 Mar 25.
Public notes

Contacts
Principal investigator
Name 0 0
Margaret E Hellard, MD PhD
Address 0 0
Burnet Institute and Alfred Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alisa Pedrana, PhD
Address 0 0
Country 0 0
Phone 0 0
+61392822225
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04061551