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

Sponsor

Kirby Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT03685045

Collaborator

National Health and Medical Research Council, Australia (Other)

1,500

Enrollment

Locations

Arm

80.1

Anticipated Duration (Months)

187.5

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Procedure: Campaign days	N/A

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 ETHOS II Project is divided into three parts:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

N/A

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.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

Anticipated Primary Completion Date :

Jan 30, 2025

Anticipated Study Completion Date :

Jan 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of participants commencing anti-HCV treatment [Every year post enrolment for up to 3 years]
Evaluation of number of participants commencing anti-HCV treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coopers Cottage, Campbelltown Drug Health Services	Campbelltown	New South Wales	Australia	2560
2	Rankin Court Treatment Centre	Darlinghurst	New South Wales	Australia	2010
3	Liverpool Opioid Treatment Program	Liverpool	New South Wales	Australia	2170
4	WSLHD Mount Druitt Drug Health OST Clinic	Mount Druitt	New South Wales	Australia	2770
5	Lawrence Avenue Methadone Program (LAMP)	Nowra	New South Wales	Australia	2541
6	The Orana Centre	Wollongong	New South Wales	Australia	2500
7	Roma Street Clinic	Brisbane	Queensland	Australia	4034
8	Youthlink	Cairns	Queensland	Australia	4870