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

RECRUITING

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.

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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).

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.

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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 : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2018-05-28

Primary completion: 2025-01-30

Study completion finish: 2025-01-30

Study type

HEALTH_SERVICES_RESEARCH

Phase

Trial ID

NCT03685045

Intervention or treatment

PROCEDURE: Campaign days

Conditions

• Hepatitis C

Condition: Hepatitis C
PROCEDURE: Campaign days
Brookvale, New South Wales, Australia and more
Sponsor: Kirby Institute

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Find a site

Closest Location:

NSLHD Brookvale Community Health Centre

Research sites nearby

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

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 All participants have the intervention of the campaign days which include hepatitis C screening, fibroscans and clinical assessments.	PROCEDURE: Campaign days Participants who consent will complete study procedures (Hep C test, fibroscan, questionnaire, clinical assessment) and followed up through medical record review.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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