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NCT Number: NCT03685045

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canberra Alliance for Harm Minimisation & Advocacy (CAHMA), Canberra, Australian Capital Territory, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Campaign days

Procedure

Participants who consent will complete study procedures (Hep C test, fibroscan, questionnaire, clinical assessment) and followed up through medical record review.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

David Silk, BSc

CONTACT

[email protected]

+61 2 9385 0878

Jessie Payne

CONTACT

[email protected]

+61 2 9348 1578

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Official study title

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

Acronym: ETHOS II

Important dates

Study start
2018
Primary completion
2026
Study completion
2028
First posted
Sep 26, 2018
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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