Eliminate Hepatitis C/EC Partnership Evaluation Protocol

August 22, 2021 updated by: Macfarlane Burnet Institute for Medical Research and Public Health Ltd

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

An estimated 71 million people are living with hepatitis C virus (HCV) world-wide, at significant risk of morbidity and mortality from liver cirrhosis, liver failure and hepatocellular carcinoma. However, the development of well-tolerated, highly-efficacious curative direct-acting antiviral treatment (DAAs) has contributed to a global push to eliminate HCV as a public health threat. The World Health Organization has developed a global strategy for elimination that calls for 90% of people living with HCV to be diagnosed and 90% of those diagnosed to be treated by 2030.

In 2015, prior to the DAAs being released, it was estimated that around 230,000 people living with HCV in Australia. Like in many other high-income countries, the group most affected by HCV in Australia are people who inject drugs (PWID), making this a key population group for Australia's HCV elimination efforts.

Despite the availability of DAAs through Australia's Pharmaceutical Benefits Scheme (PBS), numerous barriers exist for PWID to access HCV care and particularly to accessing tertiary-based care. As such, targeting community-based services that provide comprehensive care packages for PWID, including the provision of opioid substitution therapy (OST), counselling, a needle and syringe program (NSP) for the delivery of HCV treatment should increase PWIDs' engagement in HCV care. The EC Partnership program has been funded to increase capacity of community and prison services to provide HCV testing and treatment with DAA treatments by streamlining clinical pathways and reducing barriers to access.

The 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. Specifically the project aims to:

  • Increase demand for HCV treatment among PWID;
  • Increase the capacity of community services to provide HCV testing & treatment with PBS listed DAAs;
  • Increase the capacity to provide HCV testing & treatment in prison with PBS listed DAAs;
  • Streamline clinical pathways (tailored for different types of settings) to increase access to PBS listed DAAs; and
  • Establish an integrated HCV surveillance system to more accurately monitor trends in HCV prevalence and incidence over time.

To achieve this, the project will implement and evaluate a health service intervention for prison-based and community-based health services providing care to PWID. The intervention will have five main components:

  1. enhance HCV response by improving health promotion;
  2. offering training and education to service providers;
  3. streamlining clinical pathways;
  4. utilising data systems and surveillance;
  5. and implementing the results of ongoing research and evaluation.

The intervention will be evaluated using qualitative and quantitative data from health services, clinical providers and clients, which will include:

  • EC experience observational cohort data will assess predictors of patient engagement and identify barriers and enablers to progression through the cascade of care
  • Interviews with clinical service providers to assess changes to clinical pathways and to inform cost-effectiveness analysis
  • Clinical data from the Australian Collaboration for Co-ordinated Sentinel Surveillance (ACCESS) System that will track and monitor impact indictors including HCV testing, linkage to care and treatment uptake at the service and population level
  • Data from State-wide Hepatitis Assessment and Management Program (Prison programs)
  • Data from Medicare, PBS and other Victorian Department of Health and Human Services datasets (This will occur with a subset of patients who provide consent from participating sites).

In addition, the project will incorporate a sub study (Ophelia evaluation) that will be used to guide development and implementation of health promotion initiatives.

The EC Partnership evaluation aims to measure the overall impact of the EC Partnership by monitoring and evaluating specific key outcomes, including:

  • Number of PWID who uptake HCV treatment across EC partnerships services within the community and the prison system;
  • Treatment effectiveness (SVR12 cure rates & treatment failures) among community and the prison based treatment programs, compared to tertiary-based treatment programs;
  • Cost and feasibility of treating >1,160 PWID within the community and the prison systems;
  • Changes in HCV prevalence and incidence in Victoria, and comparing community and prison population estimates;
  • Model the impact of treating PWID to inform HCV elimination models in Australia and globally.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EC Clinic Support
Whole of practice interventions delivery through nurse-led model
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of treatment amongst PWID
Time Frame: 5 years
The number of PWID who commence HCV treatment across EC partnerships sites over time and compared to tertiary care models
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment effectiveness relative to tertiary care services
Time Frame: 5 years
Rates of cure, assessed as sustained virological response at 12 weeks post treatment completion (SVR12), and treatment failure amongst PWID treatment in community and prison-based services will be compared to tertiary-based treatment programs.
5 years
Costs of scaling up treatment for PWID
Time Frame: 5 years
The costs of treating >1,160 PWID within the community and prison services will be assessed.
5 years
Changes in HCV prevalence and incidence in Victoria
Time Frame: 5 years
HCV prevalence and incidence will be tracked during the project and compared to historical data.
5 years
Projected impact on HCV elimination targets
Time Frame: 5 years
Mathematical modelling studies will assess the expected impact the changes in treatment uptake, incidence and prevalence will have on the WHO incidence and mortality targets for viral hepatitis elimination. This will be used to provide an estimate of the feasibility of achieving elimination targets in Australia and in other countries.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Collaborators

National Health and Medical Research Council, Australia
Gilead Sciences
The Alfred
St Vincent's Hospital Melbourne
Burnet Institute
Victoria State Government
HepatitisVictoria
Harm Reduction Australia

Investigators

  • Principal Investigator: Margaret E Hellard, MD PhD, Burnet Institute and Alfred Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (ACTUAL)

August 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 22, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC/16/Alfred/164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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