ETHOS Cohort (Enhanced Treatment for Hepatitis C in Opioid Substitution Settings)

Date Commenced:
01/2009
Project Status
Ongoing
Expected Date of Completion:
Ongoing
Project Supporters

NHMRC Partnership Project Grant, NSW Department of Health

Currently recruiting
Yes
image - Ethos 284x284

About the Project

The purpose of the study is to examine HCV treatment uptake, response to therapy andre-infectionfollowing successful treatment among patients with chronic HCV infection and a history of injection drug use.  Factors that influence treatment uptake and response to therapy among this group will be examined prospectively. The standard HCV treatment efficacy parameters of rapid virological response (RVR), early virological response (EVR), end-of-treatment response (ETR), and sustained virological response (SVR) will be examined. Among subjects achieving an SVR, the rate of re-infection will also be prospectively evaluated.In addition, this study will evaluate the expected cost-effectiveness of providing assessment and treatment for chronic HCV infection in the opiate pharmacotherapy setting.z3147382

Rationale

The purpose of the study is to examine hepatitis C virus (HCV) treatment uptake, response to therapy and reinfection following successful treatment among patients with chronic HCV infection and a history of injection drug use. Factors that influence treatment uptake and response to therapy among this group will be examined prospectively. The standard HCV treatment efficacy parameters of rapid virological response (RVR), early virological response (EVR), end-of-treatment response (ETR), and sustained virological response (SVR) will be examined.  Among subjects achieving an SVR, the rate of re-infection will also be prospectively evaluated. In addition, this study will evaluate the expected cost-effectiveness of providing assessment and treatment for chronic HCV infection in the opiate substitution setting.

Aims

The specific objectives of this study are to examine:

1.      Assessment and treatment of HCV in a prospective cohort study, including uptake and response of HCV treatment and associated factors.

2.      Patient and provider attitudes and barriers towards the provision of services for assessment and treatment of HCV infection.

3.      Peer based support as a strategy for enhancing knowledge and uptake of treatment for HCV infection.

4.      Cost effectiveness of providing assessment and treatment for HCV infection in the opiate substitution setting.

Design & Method

1.      ETHOS Cohort

A network of clinics (primarily opiate substitution clinics) was established in 2008 and the cohort began enrolling participants in 2009.  Specialised HCV services have been established on-site at each participating clinic, run by nursing staff with support from specialist physicians.  At baseline and each 6-monthly follow-up visit, comprehensive standardised data is collected via patient and practitioner administered surveys, case note review and pathology tests.  Data collected includes demographics, medical and psychiatric history, current/previous drug and alcohol use, markers of liver disease, history of HCV assessment and treatment, willingness to receive treatment, social functioning and psychological health.  HCV treatment details and standard HCV treatment efficacy parameters are collected for those participants who commence HCV treatment.

Both patient and provider attitudes and barriers towards the provision of services for assessment and treatment of HCV infection and peer based support, as a strategy for enhancing knowledge and uptake of treatment for HCV infection, will be evaluated by qualitative methods. The qualitative evaluation will include an examination to barriers of engagement in care, assessment and treatment for HCV infection among opiate substitution clients and practitioners.

2.      Qualitative Analysis

Both patient and provider attitudes and barriers towards the provision of services for assessment and treatment of HCV infection and peer based support as a strategy for enhancing knowledge and uptake of treatment for HCV infection will be evaluated by qualitative methods. 

This evaluation will take place in four of the ETHOS clinics.  Sites have been selected to include two sites currently providing peer support programs, and two sites which are not currently providing peer support programs.

In total sixty clients will be interviewed and participant groups for clients will include;

·      People refusing assessment for HCV infection. That is, person was offered assessment but has not taken up this offer within 2 months.

·      People enrolled in ETHOS cohort but not taking up treatment

·      People enrolled in ETHOS cohort and progressing to treatment

3.      Peer‐Based Support

One of the most innovative components of the ETHOS project is the use of peer‐based support to improve knowledge and enhance HCV treatment uptake and completion. The partnership with community‐based organisations is crucial to the development and evaluation of the peer‐based support component.

Peer‐based support may vary across the ten ETHOS clinics, but each clinic will form a peer‐based support group that will meet regularly (at least monthly). All patients with chronic HCV will be encouraged to attend, although a major focus of the support group will be support for those considering and on treatment. HCV treatment specific education materials will be developed by the community‐based partner organisations to be distributed across the six clinics. The evaluation of peer‐based support will involve the following components:

·         Coverage of specific issues around peer‐based support collected within the qualitative research.

·         Further qualitative research among patients who have received HCV treatment, including those with and without regular attendance at the peer‐based support group, and patients who have taken on a role as a peer‐based worker.

·        Analyses within the ETHOS Cohort of the impact of peer‐based support on HCV treatment completion and outcomes including HRQoL change.

4.      Cost Effectiveness Analysis

A proposal to evaluate the expected cost-effectiveness of providing assessment and treatment for chronic HCV infection in the opiate substitution setting has been developed.  Variables required for this analysis will be available by performing data linkage with health registries and the collection of a quality of life instrument.

Progress/Update

Nine clinics have the required ethical and regulatory approvals to recruit participants into the study.  Participating clinics include: Clinic 36, Centre for Addiction Medicine, Kite Street Community Health Centre, Hunter New England Pharmacotherapy Services, Gateway and Woodlands Clinic, Rankin Court Treatment Centre, Regent House, Aboriginal Medical Service Western Sydney and Kirketon Road Centre.  To date, the ETHOS Cohort has enrolled 405 patients and aims to recruit 500 participants by December 2012.

Project Members
image - 1347600903 Greg Dore
Professor and Program Head
Ph 02 9385 0900
image - 1343955913 Jason Grebely Replace
Senior Lecturer
Ph 02 9385 0957
image - 1344994328 Michelle Micallef2
Clinical Project Coordinator
Ph +61 (0)2 9385 0878
image - 1338781169 Pip Marks
Clinical Trials Manager
Ph +61 (0)2 9385 0886
Project Attachment
Other Investigators

Dr Carolyn Day: Discipline of Addiction Medicine, University of Sydney

Professor Paul Haber: Sydney South West Area Health Service

Professor Bob Batey: Ministerial Advisory Committee on AIDS, Sexual Health and Hepatitis (MACASHH)

A/Professor Carla Treloar: National Centre in HIV and Social Research

Ms Claire Honey: AIDS/Infections Disease Branch, NSW Health

Ms Nicky Bath: NSW Users and AIDS Association (NUAA)

Mr Stuart Loveday: Hepatitis NSW

Dr Murray Krahn: University of Toronto

Dr Rosie Thein: University of Toronto

Ms Cate Wallace: Mental Health and Drug and Alcohol Office (MHADAO), NSW Health

Dr Nghi Phung: Centre for Addiction Medicine

Dr Annie Balcomb: Kite Street Community Health Centre

Dr Adrian Dunlop: Hunter New England Substitution Services

Dr Martin Weltman: Gateway and Woodlands Clinic

Dr Penny Abbott: Aboriginal Medical Service

Project Collaborators: External

Clinic 36: Royal Prince Alfred Hospital & University of Sydney

Centre for Addiction Medicine: Sydney West Area Health Service

Kite Street Community Health Centre: Greater Western Area Health Service

Hunter New England Substitution Services: Hunter New England Area Health Service

Gateway and Woodlands Clinic: Nepean & Blue Mountains Local Health Network

Rankin Court Treatment Centre: St Vincent’s Hospital

Regent House: Royal Prince Alfred Hospital

Aboriginal Medical Service: Western Sydney Co-operative

Kirketon Road Centre: South Eastern Sydney and Illawarra Health Service

Project Contacts

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