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

Hepatitis C Clinical Trial

— ETHOS II  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03685045
• Other study ID #: VHCRP1509
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: January 30, 2025

Study information

• Verified date: March 2024
• Source: Kirby Institute
• Contact: David Silk, BSc
• Phone: +61 2 9385 0878
• Email: dsilk[@]kirby.unsw.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: January 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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

Locations

Country	Name	City	State
Australia	Roma Street Clinic	Brisbane	Queensland
Australia	NSLHD Brookvale Community Health Centre	Brookvale	New South Wales
Australia	Youthlink	Cairns	Queensland
Australia	Coopers Cottage, Campbelltown Drug Health Services	Campbelltown	New South Wales
Australia	HNELHD Drug and Alcohol Clinical Services Cessnock	Cessnock	New South Wales
Australia	MNCLHD Coffs Harbour Alcohol and Other Drug Services	Coffs Harbour	New South Wales
Australia	Rankin Court Treatment Centre	Darlinghurst	New South Wales
Australia	Northern Drug and Alcohol Services South Australia (DASSA)	Elizabeth	South Australia
Australia	Next Step Fremantle	Fremantle	Western Australia
Australia	NNSWLHD Grafton Alcohol and Other Drug Services	Grafton	New South Wales
Australia	Next Step Joondalup	Joondalup	Western Australia
Australia	NBMLHD Drug & Alcohol Services Katoomba	Katoomba	New South Wales
Australia	MNCLHD Kempsey Alcohol and Other Drug Services	Kempsey	New South Wales
Australia	NBMLHD Drug & Alcohol Services Nepean	Kingswood	New South Wales
Australia	NNSWLHD Lismore (Riverlands) Alcohol and Other Drug Services	Lismore	New South Wales
Australia	NBMLHD Drug & Alcohol Services Lithgow	Lithgow	New South Wales
Australia	Liverpool Opioid Treatment Program	Liverpool	New South Wales
Australia	WSLHD Mount Druitt Drug Health OST Clinic	Mount Druitt	New South Wales
Australia	HNELHD Drug and Alcohol Clinical Services Newcastle	Newcastle	New South Wales
Australia	Lawrence Avenue Methadone Program (LAMP)	Nowra	New South Wales
Australia	WSLHD Fleet Street Drug Health OST Clinic	Parramatta	New South Wales
Australia	Next Step East Perth	Perth	Western Australia
Australia	MNCLHD Port Macquarie Alcohol and Other Drug Services	Port Macquarie	New South Wales
Australia	NSLHD Herbert Street Clinic	Saint Leonards	New South Wales
Australia	Central Drug and Alcohol Services South Australia (DASSA)	Stepney	South Australia
Australia	HNELHD Drug and Alcohol Clinical Services Tamworth	Tamworth	New South Wales
Australia	HNELHD Drug and Alcohol Clinical Services Taree	Taree	New South Wales
Australia	NNSWLHD Tweed Heads Alcohol and Other Drug Services	Tweed Heads	New South Wales
Australia	The Orana Centre	Wollongong	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Kirby Institute	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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