ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings (ETHOS II)

Enhancing Treatment of Hepatitis C in Opioid Substitution Settings II (ETHOS II): A Partnership Project to Enhance Hepatitis C Care in Drug and Alcohol Clinics

The overall goals of the ETHOS II Project are to enhance hepatitis C virus (HCV) care in drug treatment clinics and needle and syringe programs (NSPs) in New South Wales and Australia, and to develop a translational framework for subsequent establishment of HCV screening and treatment programs in drug treatment clinics and NSPs across NSW and nationally.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis C
• Intervention / Treatment: Procedure: Campaign days

Detailed Description

The ETHOS II Project is a collaborative research project led by the Kirby Institute, UNSW Sydney, in partnership with:

• The Centre for Social Research in Health, UNSW Sydney
• NSW Health
• NSW Users and AIDS Association
• Hepatitis NSW
• Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM)

The overall goals of the ETHOS II Project are to enhance hepatitis C virus (HCV) care in drug treatment clinics and needle and syringe programs (NSPs) in New South Wales and Australia, and to develop a translational framework for subsequent establishment of HCV screening and treatment programs in drug treatment clinics and NSPs across NSW and nationally.

The ETHOS II Project is divided into three parts:

I. ETHOS ENGAGE cohort; II. Qualitative research on barriers/facilitators to HCV care; III. HCV toolkit, education and training.

Part I: ETHOS ENGAGE The ETHOS ENGAGE cohort is a non-randomised trial to assess the effect of an intervention incorporating on-site HCV RNA testing, liver fibrosis assessment, and linkage to care to enhance scale-up of direct-acting antiviral therapy for HCV infection among people with a history of injecting drug use, and recent injecting drug use (within the last 6 months) or receiving opioid substitution therapy (OST).

In addition to the above interventions, participants will complete a survey. They will also be invited to provide consent to link data with routinely collected data from a range of population databases and registers.

Participant recruitment will take place in public and private drug treatment clinics, high case-load GPs, and NSP programmes.

A sub study will be included in ETHOS ENGAGE. As part of this sub-study, 550 participants will be invited to provide a sample of blood collected via venepuncture, which will be used to evaluate simplified HCV diagnostic assays on finger-stick and DBS samples to diagnose chronic HCV infection.

Part II: Qualitative Interviews Policy makers, clinicians and patients from selected clinics will be interviewed to examine barriers and facilitators to HCV care.

Part III: HCV toolkit, education and training A HCV education and training program (including HCV tool-kit) will be developed in collaboration with ASHM, based on learnings generated through ETHOS ENGAGE and the qualitative interviews, to enhance workforce development and improve HCV care in drug treatment clinics and needles and syringe programmes.

• Study Type: Interventional
• Enrollment (Estimated): 6000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Silk, BSc; Phone Number: +61 2 9385 0878; Email: dsilk@kirby.unsw.edu.au
• Study Contact Backup: Name: Jessie Payne; Phone Number: +61 2 9348 1578; Email: jpayne@kirby.unsw.edu.au

Study Locations

• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia, 2617
      • Recruiting
      • Canberra Alliance for Harm Minimisation & Advocacy (CAHMA)
      • Contact: Chris Gough
      • Principal Investigator: Chris Gough
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Recruiting
      • Blacktown Methadone Management Clinic
      • Principal Investigator: Thao Lam
      • Contact: Meryem Jefferies
    • Brookvale, New South Wales, Australia, 2100
      • Recruiting
      • NSLHD Brookvale Community Health Centre
      • Contact: Mark Montebello
      • Principal Investigator: Mark Montebello
    • Campbelltown, New South Wales, Australia, 2560
      • Recruiting
      • Campbelltown Drug Health Services
      • Contact: Gary Keogh
      • Principal Investigator: Gary Keogh
    • Cessnock, New South Wales, Australia, 2325
      • Active, not recruiting
      • HNELHD Drug and Alcohol Clinical Services Cessnock
    • Coffs Harbour, New South Wales, Australia, 2450
      • Recruiting
      • MNCLHD Coffs Harbour Alcohol and Other Drug Services
      • Contact: Alexandra Wade
      • Principal Investigator: Alexandra Wade
    • Darlinghurst, New South Wales, Australia, 2010
      • Recruiting
      • Rankin Court Treatment Centre
      • Contact: Craig Rodgers
      • Principal Investigator: Craig Rodgers
    • Grafton, New South Wales, Australia, 2460
      • Recruiting
      • NNSWLHD Grafton Alcohol and Other Drug Services
      • Contact: Lucy Dodds
      • Principal Investigator: Lucy Dodds
    • Katoomba, New South Wales, Australia, 2780
      • Completed
      • NBMLHD Drug & Alcohol Services Katoomba
    • Kempsey, New South Wales, Australia, 2440
      • Recruiting
      • MNCLHD Kempsey Alcohol and Other Drug Services
      • Contact: Alexandra Wade
      • Principal Investigator: Alexandra Wade
    • Lismore, New South Wales, Australia, 2480
      • Recruiting
      • NNSWLHD Lismore (Riverlands) Alcohol and Other Drug Services
      • Contact: Lucy Dodds
      • Principal Investigator: Lucy Dodds
    • Lithgow, New South Wales, Australia, 2790
      • Completed
      • NBMLHD Drug & Alcohol Services Lithgow
    • Liverpool, New South Wales, Australia, 2170
      • Recruiting
      • Liverpool Opioid Treatment Program
      • Contact: Gary Keogh
      • Principal Investigator: Gary Keogh
    • Mount Druitt, New South Wales, Australia, 2770
      • Recruiting
      • WSLHD Mount Druitt Drug Health OST Clinic
      • Principal Investigator: Thao Lam
      • Contact: Meryem Jefferies
    • Newcastle, New South Wales, Australia, 2300
      • Recruiting
      • HNELHD Drug and Alcohol Clinical Services Newcastle
      • Contact: Antoni Pazeski
      • Principal Investigator: Adrian Dunlop
    • Nowra, New South Wales, Australia, 2541
      • Recruiting
      • Lawrence Avenue Methadone Program (LAMP)
      • Principal Investigator: David Reid
      • Contact: Siyu Qian
    • Parramatta, New South Wales, Australia, 2150
      • Recruiting
      • WSLHD Fleet Street Drug Health OST Clinic
      • Principal Investigator: Thao Lam
      • Contact: Meryem Jefferies
    • Port Macquarie, New South Wales, Australia, 2444
      • Recruiting
      • MNCLHD Port Macquarie Alcohol and Other Drug Services
      • Contact: Alexandra Wade
      • Principal Investigator: Alexandra Wade
    • Saint Leonards, New South Wales, Australia, 2065
      • Recruiting
      • NSLHD Herbert Street Clinic
      • Contact: Mark Montebelllo
      • Principal Investigator: Mark Montebello
    • Tamworth, New South Wales, Australia, 2340
      • Active, not recruiting
      • HNELHD Drug and Alcohol Clinical Services Tamworth
    • Taree, New South Wales, Australia, 2430
      • Active, not recruiting
      • HNELHD Drug and Alcohol Clinical Services Taree
    • Tweed Heads, New South Wales, Australia, 2485
      • Recruiting
      • NNSWLHD Tweed Heads Alcohol and Other Drug Services
      • Contact: Lucy Dodds
      • Principal Investigator: Lucy Dodds
    • Wollongong, New South Wales, Australia, 2500
      • Recruiting
      • The Orana Centre
      • Principal Investigator: David Reid
      • Contact: Siyu Qian
  • Queensland
    • Brisbane, Queensland, Australia, 4034
      • Recruiting
      • Biala City Community Health Centre
      • Contact: Nikola Ognyenovits
      • Principal Investigator: Nikola Ognyenovits
    • Cairns, Queensland, Australia, 4870
      • Recruiting
      • Youthlink
      • Principal Investigator: Daniel Morris
      • Contact: Jessica Ben-Porat
    • Kirwan, Queensland, Australia, 4817
      • Completed
      • Queensland Injectors Health Network (QuIHN)
    • Townsville, Queensland, Australia, 4810
      • Completed
      • Townsville Sexual Health Services, North Ward Health Campus
  • South Australia
    • Elizabeth, South Australia, Australia, 5112
      • Recruiting
      • Northern Drug and Alcohol Services South Australia (DASSA)
      • Contact: Sarah Michelmore
      • Principal Investigator: Sarah Michelmore
    • Stepney, South Australia, Australia, 5069
      • Recruiting
      • Central Drug and Alcohol Services South Australia (DASSA)
      • Contact: Vicky Cock
      • Principal Investigator: Vicky Cock
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Recruiting
      • Next Step Fremantle
      • Contact: Michael Christmass
      • Principal Investigator: Michael Christmass
    • Joondalup, Western Australia, Australia, 6027
      • Recruiting
      • Next Step Joondalup
      • Contact: Craig Connelly
      • Principal Investigator: Craig Connelly
    • Perth, Western Australia, Australia, 6004
      • Recruiting
      • Next Step East Perth
      • Contact: Michael Christmass
      • Principal Investigator: Michael Christmass

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant has voluntarily signed the informed consent form;
• 18 years of age or older;
• History of injecting drug use*;

• Recent injecting drug use (previous six months) or currently receiving OST*.

  • These criteria will not apply for recruitment from residential rehabilitation centres

Exclusion Criteria:

• Nil

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Campaign Days; All participants have the intervention of the campaign days which include hepatitis C screening, fibroscans and clinical assessments.	Procedure: Campaign days; Participants who consent will complete study procedures (Hep C test, fibroscan, questionnaire, clinical assessment) and followed up through medical record review.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants commencing anti-HCV treatment	Evaluation of number of participants commencing anti-HCV treatment	Every year post enrolment for up to 3 years

Collaborators and Investigators

• Sponsor: Kirby Institute
• Collaborators: National Health and Medical Research Council, Australia
• Investigators: Study Chair: Jason Grebely, The University of New South Wales

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: hepatitis c; people who inject drugs; opioid substitution settings; OST; direct-acting antiviral treatment
• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis; Hepatitis C
• Other Study ID Numbers: VHCRP1603

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No