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

March 4, 2024 updated by: Kirby Institute

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

Intervention / Treatment

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

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

Study Contact

Study Locations

    • New South Wales
      • Brookvale, New South Wales, Australia, 2100
        • Recruiting
        • NSLHD Brookvale Community Health Centre
        • Contact:
          • Mark Montebello
      • Campbelltown, New South Wales, Australia, 2560
        • Recruiting
        • Coopers Cottage, Campbelltown Drug Health Services
        • Contact:
          • Gilbert Whitton
      • Cessnock, New South Wales, Australia, 2325
        • Not yet recruiting
        • HNELHD Drug and Alcohol Clinical Services Cessnock
        • Contact:
          • Antoni Pazeski
      • Coffs Harbour, New South Wales, Australia, 2450
        • Recruiting
        • MNCLHD Coffs Harbour Alcohol and Other Drug Services
        • Contact:
          • Alex Wade
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • Rankin Court Treatment Centre
        • Contact:
          • Robert Cherry
      • Grafton, New South Wales, Australia, 2460
        • Not yet recruiting
        • NNSWLHD Grafton Alcohol and Other Drug Services
        • Contact:
          • Patricia Collie
      • Katoomba, New South Wales, Australia, 2780
        • Recruiting
        • NBMLHD Drug & Alcohol Services Katoomba
        • Contact:
          • Rick Turner
      • Kempsey, New South Wales, Australia, 2440
        • Recruiting
        • MNCLHD Kempsey Alcohol and Other Drug Services
        • Contact:
          • Alex Wade
      • Kingswood, New South Wales, Australia, 2747
        • Recruiting
        • NBMLHD Drug & Alcohol Services Nepean
        • Contact:
          • Rick Turner
      • Lismore, New South Wales, Australia, 2480
        • Recruiting
        • NNSWLHD Lismore (Riverlands) Alcohol and Other Drug Services
        • Contact:
          • Patricia Collie
      • Lithgow, New South Wales, Australia, 2790
        • Recruiting
        • NBMLHD Drug & Alcohol Services Lithgow
        • Contact:
          • Rick Turner
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • Liverpool Opioid Treatment Program
        • Contact:
          • Gilbert Whitton
      • Mount Druitt, New South Wales, Australia, 2770
        • Recruiting
        • WSLHD Mount Druitt Drug Health OST Clinic
        • Contact:
          • Thao Lam
      • Newcastle, New South Wales, Australia, 2300
        • Recruiting
        • HNELHD Drug and Alcohol Clinical Services Newcastle
        • Contact:
          • Antoni Pazeski
      • Nowra, New South Wales, Australia, 2541
        • Recruiting
        • Lawrence Avenue Methadone Program (LAMP)
        • Contact:
          • Connie Graf
      • Parramatta, New South Wales, Australia, 2150
        • Recruiting
        • WSLHD Fleet Street Drug Health OST Clinic
        • Contact:
          • Thao Lam
      • Port Macquarie, New South Wales, Australia, 2444
        • Recruiting
        • MNCLHD Port Macquarie Alcohol and Other Drug Services
        • Contact:
          • Alex Wade
      • Saint Leonards, New South Wales, Australia, 2065
        • Recruiting
        • NSLHD Herbert Street Clinic
        • Contact:
          • Mark Montebelllo
      • Tamworth, New South Wales, Australia, 2340
        • Not yet recruiting
        • HNELHD Drug and Alcohol Clinical Services Tamworth
        • Contact:
          • Antoni Pazeski
      • Taree, New South Wales, Australia, 2430
        • Not yet recruiting
        • HNELHD Drug and Alcohol Clinical Services Taree
        • Contact:
          • Antoni Pazeski
      • Tweed Heads, New South Wales, Australia, 2485
        • Not yet recruiting
        • NNSWLHD Tweed Heads Alcohol and Other Drug Services
        • Contact:
          • Patricia Collie
      • Wollongong, New South Wales, Australia, 2500
        • Recruiting
        • The Orana Centre
        • Contact:
          • Connie Graf
    • Queensland
      • Brisbane, Queensland, Australia, 4034
        • Recruiting
        • Roma Street Clinic
        • Contact:
          • Jeremy Hayllar
      • Cairns, Queensland, Australia, 4870
        • Recruiting
        • Youthlink
        • Contact:
          • Carla Gorton
    • South Australia
      • Elizabeth, South Australia, Australia, 5112
        • Recruiting
        • Northern Drug and Alcohol Services South Australia (DASSA)
        • Contact:
          • Vicky Cock
      • Stepney, South Australia, Australia, 5069
        • Recruiting
        • Central Drug and Alcohol Services South Australia (DASSA)
        • Contact:
          • Vicky Cock
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Recruiting
        • Next Step Fremantle
        • Contact:
          • Michael Christmass
      • Joondalup, Western Australia, Australia, 6027
        • Recruiting
        • Next Step Joondalup
        • Contact:
          • Craig Connelly
      • Perth, Western Australia, Australia, 6004
        • Recruiting
        • Next Step East Perth
        • Contact:
          • Michael Christmass

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

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
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
Time Frame: Every year post enrolment for up to 3 years
Evaluation of number of participants commencing anti-HCV treatment
Every year post enrolment for up to 3 years

Collaborators and Investigators

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

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)

May 28, 2018

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

January 30, 2025

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)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

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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