Hepatitis CETHOS IINCT03685045
ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings
A study testing Campaign days in people with Hepatitis C, run by Kirby Institute at 32 sites in Australia.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Campaign days
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 32 sitesAustralia
- Study dates
- 28 May 2018to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Nil
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
32 sites in 1 country
Australia32 sites, 25 recruiting
- Recruiting
Blacktown Methadone Management Clinic
Blacktown, New South Wales, 2148
Meryem Jefferies
Thao Lam
- Recruiting
Biala City Community Health Centre
Brisbane, Queensland, 4034
Nikola Ognyenovits
Nikola Ognyenovits
- Recruiting
NSLHD Brookvale Community Health Centre
Brookvale, New South Wales, 2100
Mark Montebello
Mark Montebello
- Recruiting
Youthlink
Cairns, Queensland, 4870
Jessica Ben-Porat
Daniel Morris
- Recruiting
Campbelltown Drug Health Services
Campbelltown, New South Wales, 2560
Gary Keogh
Gary Keogh
- Recruiting
Canberra Alliance for Harm Minimisation & Advocacy (CAHMA)
Canberra, Australian Capital Territory, 2617
Chris Gough
Chris Gough
- Active, not recruiting
HNELHD Drug and Alcohol Clinical Services Cessnock
Cessnock, New South Wales, 2325
- Recruiting
MNCLHD Coffs Harbour Alcohol and Other Drug Services
Coffs Harbour, New South Wales, 2450
Alexandra Wade
Alexandra Wade
- Recruiting
Rankin Court Treatment Centre
Darlinghurst, New South Wales, 2010
Craig Rodgers
Craig Rodgers
- Recruiting
Northern Drug and Alcohol Services South Australia (DASSA)
Elizabeth, South Australia, 5112
Sarah Michelmore
Sarah Michelmore
- Recruiting
Next Step Fremantle
Fremantle, Western Australia, 6160
Michael Christmass
Michael Christmass
- Recruiting
NNSWLHD Grafton Alcohol and Other Drug Services
Grafton, New South Wales, 2460
Lucy Dodds
Lucy Dodds
- Recruiting
Next Step Joondalup
Joondalup, Western Australia, 6027
Craig Connelly
Craig Connelly
- Completed
NBMLHD Drug & Alcohol Services Katoomba
Katoomba, New South Wales, 2780
- Recruiting
MNCLHD Kempsey Alcohol and Other Drug Services
Kempsey, New South Wales, 2440
Alexandra Wade
Alexandra Wade
- Completed
Queensland Injectors Health Network (QuIHN)
Kirwan, Queensland, 4817
- Recruiting
NNSWLHD Lismore (Riverlands) Alcohol and Other Drug Services
Lismore, New South Wales, 2480
Lucy Dodds
Lucy Dodds
- Completed
NBMLHD Drug & Alcohol Services Lithgow
Lithgow, New South Wales, 2790
- Recruiting
Liverpool Opioid Treatment Program
Liverpool, New South Wales, 2170
Gary Keogh
Gary Keogh
- Recruiting
WSLHD Mount Druitt Drug Health OST Clinic
Mount Druitt, New South Wales, 2770
Meryem Jefferies
Thao Lam
- Recruiting
HNELHD Drug and Alcohol Clinical Services Newcastle
Newcastle, New South Wales, 2300
Antoni Pazeski
Adrian Dunlop
- Recruiting
Lawrence Avenue Methadone Program (LAMP)
Nowra, New South Wales, 2541
Siyu Qian
David Reid
- Recruiting
WSLHD Fleet Street Drug Health OST Clinic
Parramatta, New South Wales, 2150
Meryem Jefferies
Thao Lam
- Recruiting
Next Step East Perth
Perth, Western Australia, 6004
Michael Christmass
Michael Christmass
- Recruiting
MNCLHD Port Macquarie Alcohol and Other Drug Services
Port Macquarie, New South Wales, 2444
Alexandra Wade
Alexandra Wade
- Recruiting
NSLHD Herbert Street Clinic
Saint Leonards, New South Wales, 2065
Mark Montebelllo
Mark Montebello
- Recruiting
Central Drug and Alcohol Services South Australia (DASSA)
Stepney, South Australia, 5069
Vicky Cock
Vicky Cock
- Active, not recruiting
HNELHD Drug and Alcohol Clinical Services Tamworth
Tamworth, New South Wales, 2340
- Active, not recruiting
HNELHD Drug and Alcohol Clinical Services Taree
Taree, New South Wales, 2430
- Completed
Townsville Sexual Health Services, North Ward Health Campus
Townsville, Queensland, 4810
- Recruiting
NNSWLHD Tweed Heads Alcohol and Other Drug Services
Tweed Heads, New South Wales, 2485
Lucy Dodds
Lucy Dodds
- Recruiting
The Orana Centre
Wollongong, New South Wales, 2500
Siyu Qian
David Reid
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Hepatitis C
- Being tested
- Campaign days
- Keywords
- hepatitis c, opioid substitution settings, OST, people who inject drugs, direct-acting antiviral treatment
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Campaign daysProcedure or surgery
Participants who consent will complete study procedures (Hep C test, fibroscan, questionnaire, clinical assessment) and followed up through medical record review.
| Study group | Role | What they receive |
|---|---|---|
| Campaign Days | Experimental | All participants have the intervention of the campaign days which include hepatitis C screening, fibroscans and clinical assessments. Receives: Procedure: Campaign days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants commencing anti-HCV treatment
Evaluation of number of participants commencing anti-HCV treatment
Measured: Every year post enrolment for up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start28 May 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
- Investigators
- Jason Grebely, Study chair, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685045
- Sponsor's protocol ID
- VHCRP1603
- Acronym
- ETHOS II
- Status last verified
- May 2026
- First submitted
- 20 Sep 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03685045
- Acronym / sponsor ID
- ETHOS II / VHCRP1603
- Conditions
- Hepatitis C
- Keywords
- hepatitis c, opioid substitution settings, OST, people who inject drugs, direct-acting antiviral treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- 28 May 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Campaign Days | Experimental | Procedure: Campaign daysAll participants have the intervention of the campaign days which include hepatitis C screening, fibroscans and clinical assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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*.
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Campaign daysParticipants who consent will complete study procedures (Hep C test, fibroscan, questionnaire, clinical assessment) and followed up through medical record review. | Procedure or surgery | Campaign Days |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Grebely study chair
The University of New South Wales
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Campaign days in people with Hepatitis C, run by Kirby Institute at 32 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Silk, BSc (+61 2 9385 0878, dsilk@kirby.unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants commencing anti-HCV treatment (time frame: Every year post enrolment for up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.