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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hepatitis C

Intervention / Treatment
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* Procedure: Campaign days


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Women who are, or might be pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Campaign Days<br>All participants have the intervention of the campaign days which include hepatitis C screening, fibroscans and clinical assessments. | Procedure: Campaign days<br>* Participants who consent will complete study procedures (Hep C test, fibroscan, questionnaire, clinical assessment) and followed up through medical record review.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OST, people who inject drugs, direct-acting antiviral treatment, hepatitis c, opioid substitution settings