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Recruiting NCT03685045

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

No phase Interventional Hepatitis C

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Campaign days.
Who it may be relevant to
Registry conditions: Hepatitis C. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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

  • Number of participants commencing anti-HCV treatment [Time frame: Every year post enrolment for up to 3 years]

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\*.
  • These criteria will not apply for recruitment from residential rehabilitation centres

Exclusion criteria

  • Nil

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Australia · 32 centers
  • Canberra Alliance for Harm Minimisation & Advocacy (CAHMA) — Canberra
  • Blacktown Methadone Management Clinic — Blacktown
  • NSLHD Brookvale Community Health Centre — Brookvale
  • Campbelltown Drug Health Services — Campbelltown
  • HNELHD Drug and Alcohol Clinical Services Cessnock — Cessnock
  • MNCLHD Coffs Harbour Alcohol and Other Drug Services — Coffs Harbour
  • Rankin Court Treatment Centre — Darlinghurst
  • NNSWLHD Grafton Alcohol and Other Drug Services — Grafton
  • … and 24 more centers

Identifiers

NCT: NCT03685045 · VHCRP1603

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗