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

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.
  • Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2018-05-28

    Primary completion: 2025-01-30

    Study completion finish: 2025-01-30

    study type

    Study type

    HEALTH_SERVICES_RESEARCH

    phase

    Phase

      NA

    trial

    Trial ID

    NCT03685045

    Intervention or treatment

    PROCEDURE: Campaign days

    Conditions

    • Hepatitis C

    Find a site

    Closest Location:

    NSLHD Brookvale Community Health Centre

    Research sites nearby

    Select from list below to view details:

    • NSLHD Brookvale Community Health Centre

      Brookvale, New South Wales, Australia

    • Coopers Cottage, Campbelltown Drug Health Services

      Campbelltown, New South Wales, Australia

    • HNELHD Drug and Alcohol Clinical Services Cessnock

      Cessnock, New South Wales, Australia

    • MNCLHD Coffs Harbour Alcohol and Other Drug Services

      Coffs Harbour, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/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.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Number of participants commencing anti-HCV treatmentEvaluation of number of participants commencing anti-HCV treatmentEvery year post enrolment for up to 3 years

    Secondary outcome

    Frequently Asked Questions

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    References

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

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