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

Last updated: March 4, 2024
Sponsor: Kirby Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis

Liver Disorders

Treatment

Campaign days

Clinical Study ID

NCT03685045
VHCRP1509
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 rehabilitationcentres

Exclusion

Exclusion Criteria:

  • Nil

Study Design

Total Participants: 6000
Treatment Group(s): 1
Primary Treatment: Campaign days
Phase:
Study Start date:
May 28, 2018
Estimated Completion Date:
January 30, 2025

Study 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.

Connect with a study center

  • NSLHD Brookvale Community Health Centre

    Brookvale, New South Wales 2100
    Australia

    Active - Recruiting

  • Coopers Cottage, Campbelltown Drug Health Services

    Campbelltown, New South Wales 2560
    Australia

    Active - Recruiting

  • HNELHD Drug and Alcohol Clinical Services Cessnock

    Cessnock, New South Wales 2325
    Australia

    Site Not Available

  • MNCLHD Coffs Harbour Alcohol and Other Drug Services

    Coffs Harbour, New South Wales 2450
    Australia

    Active - Recruiting

  • Rankin Court Treatment Centre

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • NNSWLHD Grafton Alcohol and Other Drug Services

    Grafton, New South Wales 2460
    Australia

    Site Not Available

  • NBMLHD Drug & Alcohol Services Katoomba

    Katoomba, New South Wales 2780
    Australia

    Active - Recruiting

  • MNCLHD Kempsey Alcohol and Other Drug Services

    Kempsey, New South Wales 2440
    Australia

    Active - Recruiting

  • NBMLHD Drug & Alcohol Services Nepean

    Kingswood, New South Wales 2747
    Australia

    Active - Recruiting

  • NNSWLHD Lismore (Riverlands) Alcohol and Other Drug Services

    Lismore, New South Wales 2480
    Australia

    Active - Recruiting

  • NBMLHD Drug & Alcohol Services Lithgow

    Lithgow, New South Wales 2790
    Australia

    Active - Recruiting

  • Liverpool Opioid Treatment Program

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • WSLHD Mount Druitt Drug Health OST Clinic

    Mount Druitt, New South Wales 2770
    Australia

    Active - Recruiting

  • HNELHD Drug and Alcohol Clinical Services Newcastle

    Newcastle, New South Wales 2300
    Australia

    Active - Recruiting

  • Lawrence Avenue Methadone Program (LAMP)

    Nowra, New South Wales 2541
    Australia

    Active - Recruiting

  • WSLHD Fleet Street Drug Health OST Clinic

    Parramatta, New South Wales 2150
    Australia

    Active - Recruiting

  • MNCLHD Port Macquarie Alcohol and Other Drug Services

    Port Macquarie, New South Wales 2444
    Australia

    Active - Recruiting

  • NSLHD Herbert Street Clinic

    Saint Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • HNELHD Drug and Alcohol Clinical Services Tamworth

    Tamworth, New South Wales 2340
    Australia

    Site Not Available

  • HNELHD Drug and Alcohol Clinical Services Taree

    Taree, New South Wales 2430
    Australia

    Site Not Available

  • NNSWLHD Tweed Heads Alcohol and Other Drug Services

    Tweed Heads, New South Wales 2485
    Australia

    Site Not Available

  • The Orana Centre

    Wollongong, New South Wales 2500
    Australia

    Active - Recruiting

  • Roma Street Clinic

    Brisbane, Queensland 4034
    Australia

    Active - Recruiting

  • Youthlink

    Cairns, Queensland 4870
    Australia

    Active - Recruiting

  • Northern Drug and Alcohol Services South Australia (DASSA)

    Elizabeth, South Australia 5112
    Australia

    Active - Recruiting

  • Central Drug and Alcohol Services South Australia (DASSA)

    Stepney, South Australia 5069
    Australia

    Active - Recruiting

  • Next Step Fremantle

    Fremantle, Western Australia 6160
    Australia

    Active - Recruiting

  • Next Step Joondalup

    Joondalup, Western Australia 6027
    Australia

    Active - Recruiting

  • Next Step East Perth

    Perth, Western Australia 6004
    Australia

    Active - Recruiting

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