NCT04061551

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

5.1 years

First QC Date

June 4, 2019

Last Update Submit

August 22, 2021

Conditions

Hepatitis CChronic Hepatitis cHepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • Uptake of treatment amongst PWID

    The number of PWID who commence HCV treatment across EC partnerships sites over time and compared to tertiary care models

    5 years

Secondary Outcomes (4)

  • Treatment effectiveness relative to tertiary care services

    5 years

  • Costs of scaling up treatment for PWID

    5 years

  • Changes in HCV prevalence and incidence in Victoria

    5 years

  • Projected impact on HCV elimination targets

    5 years

Study Arms (1)

EC Clinic Support

EXPERIMENTAL

Whole of practice interventions delivery through nurse-led model

Other: EC clinic support - whole of practice interventions delivery through nurse-led model

Interventions

EC clinic support - whole of practice interventions delivery through nurse-led modelOTHER

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

EC Clinic Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Burnet Institute

Melbourne, Victoria, 3004, Australia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 27196586BACKGROUND

  • 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.

    PMID: 28797497BACKGROUND

  • 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.

    PMID: 30908706BACKGROUND

MeSH Terms

Conditions

Hepatitis CHepatitis C, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Margaret E Hellard, MD PhD

    Burnet Institute and Alfred Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisa Pedrana, PhD

CONTACT

+61392822225alisa.pedrana@burnet.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The comprehensive intervention will be implemented at all participating sites, although specific components of the intervention will be tailored to the needs of each site. The model consists of five stages: 1. Baseline site assessment 2. Co-design intervention to streamline HCV clinical pathways 3. Implementation 4. Six-monthly review 5. End line review
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2019

First Posted

August 20, 2019

Study Start

December 1, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)