Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03685045




Registration number
NCT03685045
Ethics application status
Date submitted
20/09/2018
Date registered
26/09/2018
Date last updated
6/03/2024

Titles & IDs
Public title
ETHOS ENGAGE: Enhancing Treatment of Hepatitis C in Opioid Substitution Settings
Scientific 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
Secondary ID [1] 0 0
VHCRP1509
Universal Trial Number (UTN)
Trial acronym
ETHOS II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Campaign days

Experimental: Campaign Days - All participants have the intervention of the campaign days which include hepatitis C screening, fibroscans and clinical assessments.


Treatment: Surgery: Campaign days
Participants who consent will complete study procedures (Hep C test, fibroscan, questionnaire, clinical assessment) and followed up through medical record review.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants commencing anti-HCV treatment
Timepoint [1] 0 0
Every year post enrolment for up to 3 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Nil

Study design
Purpose of the study
Health Services Research
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2025
Actual
Sample size
Target
6000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
NSLHD Brookvale Community Health Centre - Brookvale
Recruitment hospital [2] 0 0
Coopers Cottage, Campbelltown Drug Health Services - Campbelltown
Recruitment hospital [3] 0 0
HNELHD Drug and Alcohol Clinical Services Cessnock - Cessnock
Recruitment hospital [4] 0 0
MNCLHD Coffs Harbour Alcohol and Other Drug Services - Coffs Harbour
Recruitment hospital [5] 0 0
Rankin Court Treatment Centre - Darlinghurst
Recruitment hospital [6] 0 0
NNSWLHD Grafton Alcohol and Other Drug Services - Grafton
Recruitment hospital [7] 0 0
NBMLHD Drug & Alcohol Services Katoomba - Katoomba
Recruitment hospital [8] 0 0
MNCLHD Kempsey Alcohol and Other Drug Services - Kempsey
Recruitment hospital [9] 0 0
NBMLHD Drug & Alcohol Services Nepean - Kingswood
Recruitment hospital [10] 0 0
NNSWLHD Lismore (Riverlands) Alcohol and Other Drug Services - Lismore
Recruitment hospital [11] 0 0
NBMLHD Drug & Alcohol Services Lithgow - Lithgow
Recruitment hospital [12] 0 0
Liverpool Opioid Treatment Program - Liverpool
Recruitment hospital [13] 0 0
WSLHD Mount Druitt Drug Health OST Clinic - Mount Druitt
Recruitment hospital [14] 0 0
HNELHD Drug and Alcohol Clinical Services Newcastle - Newcastle
Recruitment hospital [15] 0 0
Lawrence Avenue Methadone Program (LAMP) - Nowra
Recruitment hospital [16] 0 0
WSLHD Fleet Street Drug Health OST Clinic - Parramatta
Recruitment hospital [17] 0 0
MNCLHD Port Macquarie Alcohol and Other Drug Services - Port Macquarie
Recruitment hospital [18] 0 0
NSLHD Herbert Street Clinic - Saint Leonards
Recruitment hospital [19] 0 0
HNELHD Drug and Alcohol Clinical Services Tamworth - Tamworth
Recruitment hospital [20] 0 0
HNELHD Drug and Alcohol Clinical Services Taree - Taree
Recruitment hospital [21] 0 0
NNSWLHD Tweed Heads Alcohol and Other Drug Services - Tweed Heads
Recruitment hospital [22] 0 0
The Orana Centre - Wollongong
Recruitment hospital [23] 0 0
Roma Street Clinic - Brisbane
Recruitment hospital [24] 0 0
Youthlink - Cairns
Recruitment hospital [25] 0 0
Northern Drug and Alcohol Services South Australia (DASSA) - Elizabeth
Recruitment hospital [26] 0 0
Central Drug and Alcohol Services South Australia (DASSA) - Stepney
Recruitment hospital [27] 0 0
Next Step Fremantle - Fremantle
Recruitment hospital [28] 0 0
Next Step Joondalup - Joondalup
Recruitment hospital [29] 0 0
Next Step East Perth - Perth
Recruitment postcode(s) [1] 0 0
2100 - Brookvale
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
2325 - Cessnock
Recruitment postcode(s) [4] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [6] 0 0
2460 - Grafton
Recruitment postcode(s) [7] 0 0
2780 - Katoomba
Recruitment postcode(s) [8] 0 0
2440 - Kempsey
Recruitment postcode(s) [9] 0 0
2747 - Kingswood
Recruitment postcode(s) [10] 0 0
2480 - Lismore
Recruitment postcode(s) [11] 0 0
2790 - Lithgow
Recruitment postcode(s) [12] 0 0
2170 - Liverpool
Recruitment postcode(s) [13] 0 0
2770 - Mount Druitt
Recruitment postcode(s) [14] 0 0
2300 - Newcastle
Recruitment postcode(s) [15] 0 0
2541 - Nowra
Recruitment postcode(s) [16] 0 0
2150 - Parramatta
Recruitment postcode(s) [17] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [18] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [19] 0 0
2340 - Tamworth
Recruitment postcode(s) [20] 0 0
2430 - Taree
Recruitment postcode(s) [21] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [22] 0 0
2500 - Wollongong
Recruitment postcode(s) [23] 0 0
4034 - Brisbane
Recruitment postcode(s) [24] 0 0
4870 - Cairns
Recruitment postcode(s) [25] 0 0
5112 - Elizabeth
Recruitment postcode(s) [26] 0 0
5069 - Stepney
Recruitment postcode(s) [27] 0 0
6160 - Fremantle
Recruitment postcode(s) [28] 0 0
6027 - Joondalup
Recruitment postcode(s) [29] 0 0
6004 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT03685045
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Silk, BSc
Address 0 0
Country 0 0
Phone 0 0
+61 2 9385 0878
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03685045