Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03685045
Acronym
ETHOS II
Enrollment
6000
Registered
2018-09-26
Start date
2018-05-28
Completion date
2028-12-31
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

hepatitis c, opioid substitution settings, OST, people who inject drugs, direct-acting antiviral treatment

Brief 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.

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.

Interventions

PROCEDURECampaign days

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

Sponsors

Kirby Institute
Lead SponsorOTHER_GOV
National Health and Medical Research Council, Australia
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The intervention is the campaign days where all participants will undergo a questionnaire, point of care and dried blood spot testing for hepatitis C, fibroscan and a clinical assessment.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants commencing anti-HCV treatmentEvery year post enrolment for up to 3 yearsEvaluation of number of participants commencing anti-HCV treatment

Countries

Australia

Contacts

CONTACTDavid Silk, BSc
dsilk@kirby.unsw.edu.au+61 2 9385 0878
CONTACTJessie Payne
jpayne@kirby.unsw.edu.au+61 2 9348 1578
STUDY_CHAIRJason Grebely

The University of New South Wales

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026