ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings (ETHOS II)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03685045|
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Procedure: Campaign days||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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|
|Actual Study Start Date :||May 28, 2018|
|Estimated Primary Completion Date :||January 30, 2022|
|Estimated Study Completion Date :||January 30, 2022|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685045
|Contact: David Silk, BSc||+61 2 9385 firstname.lastname@example.org|
|Australia, New South Wales|
|Coopers Cottage, Campbelltown Drug Health Services||Recruiting|
|Campbelltown, New South Wales, Australia, 2560|
|Contact: Carina Burns|
|Rankin Court Treatment Centre||Recruiting|
|Darlinghurst, New South Wales, Australia, 2010|
|Contact: Robert Cherry|
|Liverpool Opioid Treatment Program||Recruiting|
|Liverpool, New South Wales, Australia, 2170|
|Contact: Michael Edwards|
|WSLHD Mount Druitt Drug Health OST Clinic||Not yet recruiting|
|Mount Druitt, New South Wales, Australia, 2770|
|Contact: Thao Lam|
|Lawrence Avenue Methadone Program (LAMP)||Recruiting|
|Nowra, New South Wales, Australia, 2541|
|Contact: Connie Graf|
|The Orana Centre||Recruiting|
|Wollongong, New South Wales, Australia, 2500|
|Contact: Connie Graf|
|Roma Street Clinic||Not yet recruiting|
|Brisbane, Queensland, Australia, 4034|
|Contact: Jeremy Hayllar|
|Cairns, Queensland, Australia, 4870|
|Contact: Carla Gorton|