Clinical trial NCT03685045: ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatitis C
Keywords: hepatitis c
opioid substitution settings
OST
people who inject drugs
direct-acting antiviral treatment
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2018-09-26
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants commencing anti-HCV treatment
timeFrame: Every year post enrolment for up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brookvale
country: Australia
facility: NSLHD Brookvale Community Health Centre
state: New South Wales
city: Campbelltown
country: Australia
facility: Coopers Cottage, Campbelltown Drug Health Services
state: New South Wales
city: Cessnock
country: Australia
facility: HNELHD Drug and Alcohol Clinical Services Cessnock
state: New South Wales
city: Coffs Harbour
country: Australia
facility: MNCLHD Coffs Harbour Alcohol and Other Drug Services
state: New South Wales
city: Darlinghurst
country: Australia
facility: Rankin Court Treatment Centre
state: New South Wales
city: Grafton
country: Australia
facility: NNSWLHD Grafton Alcohol and Other Drug Services
state: New South Wales
city: Katoomba
country: Australia
facility: NBMLHD Drug & Alcohol Services Katoomba
state: New South Wales
city: Kempsey
country: Australia
facility: MNCLHD Kempsey Alcohol and Other Drug Services
state: New South Wales
city: Kingswood
country: Australia
facility: NBMLHD Drug & Alcohol Services Nepean
state: New South Wales
city: Lismore
country: Australia
facility: NNSWLHD Lismore (Riverlands) Alcohol and Other Drug Services
state: New South Wales
city: Lithgow
country: Australia
facility: NBMLHD Drug & Alcohol Services Lithgow
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Opioid Treatment Program
state: New South Wales
city: Mount Druitt
country: Australia
facility: WSLHD Mount Druitt Drug Health OST Clinic
state: New South Wales
city: Newcastle
country: Australia
facility: HNELHD Drug and Alcohol Clinical Services Newcastle
state: New South Wales
city: Nowra
country: Australia
facility: Lawrence Avenue Methadone Program (LAMP)
state: New South Wales
city: Parramatta
country: Australia
facility: WSLHD Fleet Street Drug Health OST Clinic
state: New South Wales
city: Port Macquarie
country: Australia
facility: MNCLHD Port Macquarie Alcohol and Other Drug Services
state: New South Wales
city: Saint Leonards
country: Australia
facility: NSLHD Herbert Street Clinic
state: New South Wales
city: Tamworth
country: Australia
facility: HNELHD Drug and Alcohol Clinical Services Tamworth
state: New South Wales
city: Taree
country: Australia
facility: HNELHD Drug and Alcohol Clinical Services Taree
state: New South Wales
city: Tweed Heads
country: Australia
facility: NNSWLHD Tweed Heads Alcohol and Other Drug Services
state: New South Wales
city: Wollongong
country: Australia
facility: The Orana Centre
state: New South Wales
city: Brisbane
country: Australia
facility: Roma Street Clinic
state: Queensland
city: Cairns
country: Australia
facility: Youthlink
state: Queensland
city: Elizabeth
country: Australia
facility: Northern Drug and Alcohol Services South Australia (DASSA)
state: South Australia
city: Stepney
country: Australia
facility: Central Drug and Alcohol Services South Australia (DASSA)
state: South Australia
city: Fremantle
country: Australia
facility: Next Step Fremantle
state: Western Australia
city: Joondalup
country: Australia
facility: Next Step Joondalup
state: Western Australia
city: Perth
country: Australia
facility: Next Step East Perth
state: Western Australia
Study officials:
References: