- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03685045
ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings (ETHOS II)
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
Study Overview
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Silk, BSc
- Phone Number: +61 2 9385 0878
- Email: dsilk@kirby.unsw.edu.au
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VHCRP1509
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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