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

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ClinicalTrials.gov Identifier: NCT03685045
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Kirby Institute

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Procedure: Campaign days Not Applicable

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.


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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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Exclusion Criteria:

  • Women who are, or might be pregnant.

Information from the National Library of Medicine

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


Contacts
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Contact: David Silk, BSc +61 2 9385 0878 dsilk@kirby.unsw.edu.au

Locations
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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         
Australia, Queensland
Roma Street Clinic Not yet recruiting
Brisbane, Queensland, Australia, 4034
Contact: Jeremy Hayllar         
Youthlink Recruiting
Cairns, Queensland, Australia, 4870
Contact: Carla Gorton         
Sponsors and Collaborators
Kirby Institute
National Health and Medical Research Council, Australia

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Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT03685045     History of Changes
Other Study ID Numbers: VHCRP1509
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kirby Institute:
hepatitis c
opioid substitution settings
OST
people who inject drugs
direct-acting antiviral treatment

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents