NCT03685045

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

32 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
May 2018Dec 2028

Study Start

First participant enrolled

May 28, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

8.6 years

First QC Date

September 20, 2018

Last Update Submit

May 11, 2026

Conditions

Keywords

hepatitis copioid substitution settingsOSTpeople who inject drugsdirect-acting antiviral treatment

Outcome Measures

Primary Outcomes (1)

  • Number of participants commencing anti-HCV treatment

    Evaluation of number of participants commencing anti-HCV treatment

    Every year post enrolment for up to 3 years

Study Arms (1)

Campaign Days

EXPERIMENTAL

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

Procedure: Campaign days

Interventions

Campaign daysPROCEDURE

Participants who consent will complete study procedures (Hep C test, fibroscan, questionnaire, clinical assessment) and followed up through medical record review.

Campaign Days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant has voluntarily signed the informed consent form;
  • 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

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Canberra Alliance for Harm Minimisation & Advocacy (CAHMA)

Canberra, Australian Capital Territory, 2617, Australia

RECRUITING

Blacktown Methadone Management Clinic

Blacktown, New South Wales, 2148, Australia

RECRUITING

NSLHD Brookvale Community Health Centre

Brookvale, New South Wales, 2100, Australia

RECRUITING

Campbelltown Drug Health Services

Campbelltown, New South Wales, 2560, Australia

RECRUITING

HNELHD Drug and Alcohol Clinical Services Cessnock

Cessnock, New South Wales, 2325, Australia

ACTIVE NOT RECRUITING

MNCLHD Coffs Harbour Alcohol and Other Drug Services

Coffs Harbour, New South Wales, 2450, Australia

RECRUITING

Rankin Court Treatment Centre

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

NNSWLHD Grafton Alcohol and Other Drug Services

Grafton, New South Wales, 2460, Australia

RECRUITING

NBMLHD Drug & Alcohol Services Katoomba

Katoomba, New South Wales, 2780, Australia

COMPLETED

MNCLHD Kempsey Alcohol and Other Drug Services

Kempsey, New South Wales, 2440, Australia

RECRUITING

NNSWLHD Lismore (Riverlands) Alcohol and Other Drug Services

Lismore, New South Wales, 2480, Australia

RECRUITING

NBMLHD Drug & Alcohol Services Lithgow

Lithgow, New South Wales, 2790, Australia

COMPLETED

Liverpool Opioid Treatment Program

Liverpool, New South Wales, 2170, Australia

RECRUITING

WSLHD Mount Druitt Drug Health OST Clinic

Mount Druitt, New South Wales, 2770, Australia

RECRUITING

HNELHD Drug and Alcohol Clinical Services Newcastle

Newcastle, New South Wales, 2300, Australia

RECRUITING

Lawrence Avenue Methadone Program (LAMP)

Nowra, New South Wales, 2541, Australia

RECRUITING

WSLHD Fleet Street Drug Health OST Clinic

Parramatta, New South Wales, 2150, Australia

RECRUITING

MNCLHD Port Macquarie Alcohol and Other Drug Services

Port Macquarie, New South Wales, 2444, Australia

RECRUITING

NSLHD Herbert Street Clinic

Saint Leonards, New South Wales, 2065, Australia

RECRUITING

HNELHD Drug and Alcohol Clinical Services Tamworth

Tamworth, New South Wales, 2340, Australia

ACTIVE NOT RECRUITING

HNELHD Drug and Alcohol Clinical Services Taree

Taree, New South Wales, 2430, Australia

ACTIVE NOT RECRUITING

NNSWLHD Tweed Heads Alcohol and Other Drug Services

Tweed Heads, New South Wales, 2485, Australia

RECRUITING

The Orana Centre

Wollongong, New South Wales, 2500, Australia

RECRUITING

Biala City Community Health Centre

Brisbane, Queensland, 4034, Australia

RECRUITING

Youthlink

Cairns, Queensland, 4870, Australia

RECRUITING

Queensland Injectors Health Network (QuIHN)

Kirwan, Queensland, 4817, Australia

COMPLETED

Townsville Sexual Health Services, North Ward Health Campus

Townsville, Queensland, 4810, Australia

COMPLETED

Northern Drug and Alcohol Services South Australia (DASSA)

Elizabeth, South Australia, 5112, Australia

RECRUITING

Central Drug and Alcohol Services South Australia (DASSA)

Stepney, South Australia, 5069, Australia

RECRUITING

Next Step Fremantle

Fremantle, Western Australia, 6160, Australia

RECRUITING

Next Step Joondalup

Joondalup, Western Australia, 6027, Australia

RECRUITING

Next Step East Perth

Perth, Western Australia, 6004, Australia

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Jason Grebely

    The University of New South Wales

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 26, 2018

Study Start

May 28, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations