ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings
- Conditions
- Hepatitis C
- Interventions
- Procedure: Campaign days
- Registration Number
- NCT03685045
- Lead Sponsor
- Kirby Institute
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6000
-
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
- Nil
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Campaign Days Campaign days All participants have the intervention of the campaign days which include hepatitis C screening, fibroscans and clinical assessments.
- Primary Outcome Measures
Name Time Method Number of participants commencing anti-HCV treatment Every year post enrolment for up to 3 years Evaluation of number of participants commencing anti-HCV treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Lawrence Avenue Methadone Program (LAMP)
🇦🇺Nowra, New South Wales, Australia
WSLHD Mount Druitt Drug Health OST Clinic
🇦🇺Mount Druitt, New South Wales, Australia
NSLHD Brookvale Community Health Centre
🇦🇺Brookvale, New South Wales, Australia
Rankin Court Treatment Centre
🇦🇺Darlinghurst, New South Wales, Australia
Liverpool Opioid Treatment Program
🇦🇺Liverpool, New South Wales, Australia
NNSWLHD Lismore (Riverlands) Alcohol and Other Drug Services
🇦🇺Lismore, New South Wales, Australia
Youthlink
🇦🇺Cairns, Queensland, Australia
NNSWLHD Grafton Alcohol and Other Drug Services
🇦🇺Grafton, New South Wales, Australia
Central Drug and Alcohol Services South Australia (DASSA)
🇦🇺Stepney, South Australia, Australia
Roma Street Clinic
🇦🇺Brisbane, Queensland, 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
MNCLHD Kempsey Alcohol and Other Drug Services
🇦🇺Kempsey, New South Wales, Australia
NBMLHD Drug & Alcohol Services Lithgow
🇦🇺Lithgow, New South Wales, Australia
Coopers Cottage, Campbelltown Drug Health Services
🇦🇺Campbelltown, New South Wales, Australia
NBMLHD Drug & Alcohol Services Katoomba
🇦🇺Katoomba, New South Wales, Australia
NBMLHD Drug & Alcohol Services Nepean
🇦🇺Kingswood, New South Wales, Australia
HNELHD Drug and Alcohol Clinical Services Newcastle
🇦🇺Newcastle, New South Wales, Australia
WSLHD Fleet Street Drug Health OST Clinic
🇦🇺Parramatta, New South Wales, Australia
NSLHD Herbert Street Clinic
🇦🇺Saint Leonards, New South Wales, Australia
Northern Drug and Alcohol Services South Australia (DASSA)
🇦🇺Elizabeth, South Australia, Australia
Next Step East Perth
🇦🇺Perth, Western Australia, Australia
Next Step Fremantle
🇦🇺Fremantle, Western Australia, Australia
Next Step Joondalup
🇦🇺Joondalup, Western Australia, Australia
MNCLHD Port Macquarie Alcohol and Other Drug Services
🇦🇺Port Macquarie, New South Wales, Australia
HNELHD Drug and Alcohol Clinical Services Tamworth
🇦🇺Tamworth, New South Wales, Australia
The Orana Centre
🇦🇺Wollongong, 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