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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

Tracking Information
First Submitted Date  ICMJE September 20, 2018
First Posted Date  ICMJE September 26, 2018
Last Update Posted Date September 26, 2018
Actual Study Start Date  ICMJE May 28, 2018
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Hepatitis C
Intervention  ICMJE Procedure: Campaign days
Participants who consent will complete study procedures (Hep C test, fibroscan, questionnaire, clinical assessment) and followed up through medical record review.
Study Arms  ICMJE Experimental: Campaign Days
All participants have the intervention of the campaign days which include hepatitis C screening, fibroscans and clinical assessments.
Intervention: Procedure: Campaign days
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2018)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2022
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: David Silk, BSc +61 2 9385 0878 dsilk@kirby.unsw.edu.au
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03685045
Other Study ID Numbers  ICMJE VHCRP1509
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kirby Institute
Study Sponsor  ICMJE Kirby Institute
Collaborators  ICMJE National Health and Medical Research Council, Australia
Investigators  ICMJE Not Provided
PRS Account Kirby Institute
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP