ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
HEALTH_SERVICES_RESEARCH
Phase
- NA
Study ID
NCT03685045
Intervention or treatment
PROCEDURE: Campaign days
Conditions
- Hepatitis C
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
NSLHD Brookvale Community Health Centre
Select from list below to view details:
NSLHD Brookvale Community Health Centre
Brookvale, New South Wales, Australia
Coopers Cottage, Campbelltown Drug Health Services
Campbelltown, New South Wales, 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
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Who is running the clinical trial?
Kirby Institute
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Campaign Days
| Procedure: Campaign days |
What is the study measuring?
Primary Outcome
| 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 |
Secondary Outcome
References
Clinical Trials Gov: ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution SettingsOther trials to consider
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