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

Primary Purpose

Hepatitis C

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Campaign days
Sponsored by
Kirby Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hepatitis C focused on measuring hepatitis c, opioid substitution settings, OST, people who inject drugs, direct-acting antiviral treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Coopers Cottage, Campbelltown Drug Health ServicesRecruiting
  • Rankin Court Treatment CentreRecruiting
  • Liverpool Opioid Treatment ProgramRecruiting
  • WSLHD Mount Druitt Drug Health OST Clinic
  • Lawrence Avenue Methadone Program (LAMP)Recruiting
  • The Orana CentreRecruiting
  • Roma Street Clinic
  • YouthlinkRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Campaign Days

Arm Description

All participants have the intervention of the campaign days which include hepatitis C screening, fibroscans and clinical assessments.

Outcomes

Primary Outcome Measures

Number of participants commencing anti-HCV treatment
Evaluation of number of participants commencing anti-HCV treatment

Secondary Outcome Measures

Full Information

First Posted
September 20, 2018
Last Updated
March 30, 2022
Sponsor
Kirby Institute
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT03685045
Brief Title
ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings
Acronym
ETHOS II
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
January 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kirby Institute
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
hepatitis c, opioid substitution settings, OST, people who inject drugs, direct-acting antiviral treatment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Campaign Days
Arm Type
Experimental
Arm Description
All participants have the intervention of the campaign days which include hepatitis C screening, fibroscans and clinical assessments.
Intervention Type
Procedure
Intervention Name(s)
Campaign days
Intervention Description
Participants who consent will complete study procedures (Hep C test, fibroscan, questionnaire, clinical assessment) and followed up through medical record review.
Primary Outcome Measure Information:
Title
Number of participants commencing anti-HCV treatment
Description
Evaluation of number of participants commencing anti-HCV treatment
Time Frame
Every year post enrolment for up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Silk, BSc
Phone
+61 2 9385 0878
Email
dsilk@kirby.unsw.edu.au
Facility Information:
Facility Name
Coopers Cottage, Campbelltown Drug Health Services
City
Campbelltown
State/Province
New South Wales
ZIP/Postal Code
2560
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carina Burns
Facility Name
Rankin Court Treatment Centre
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Cherry
Facility Name
Liverpool Opioid Treatment Program
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Edwards
Facility Name
WSLHD Mount Druitt Drug Health OST Clinic
City
Mount Druitt
State/Province
New South Wales
ZIP/Postal Code
2770
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thao Lam
Facility Name
Lawrence Avenue Methadone Program (LAMP)
City
Nowra
State/Province
New South Wales
ZIP/Postal Code
2541
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie Graf
Facility Name
The Orana Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie Graf
Facility Name
Roma Street Clinic
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4034
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Hayllar
Facility Name
Youthlink
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Gorton

12. IPD Sharing Statement

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

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