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Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30%

Primary Purpose

Hepatitis C

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Xpert HCV Viral load finger stick point of care test (Cepheid)
Epclusa 400Mg-100Mg Tablet
Standard of care
Sponsored by
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • attending primary health care service of CHHS aged 18 years or over

Exclusion Criteria: only for intervention arm test and treat

  • Known to have hepatitis B or HIV infection
  • Known to have cirrhosis
  • Previous treatment with direct acting antivirals
  • Previously received interferon-based hepatitis C treatment that did not work
  • Women that are pregnant or breastfeeding
  • Already receiving hepatitis C treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Other

    Other

    Arm Label

    Test and treat

    General Practitioner Refresher and Clinic in reach

    Incentive and Peer intervention in HCV care cascade

    Arm Description

    This group will receive POC HCV viral load testing via a fingerstick using the Xpert HCV Viral load finger stick point of care test (Cepheid) in addition to the standard of care whole blood conventional laboratory based HCV PCR viral load testing. Participants who return a positive POC HCV viral load result will be provided with Epclusa on the same day as result. Follow up management will be determined by results received from standard of care blood. Service level data will be investigated to estimate HCV targeted treatment numbers prior to intervention arms implementation. Service level data will be measured post intervention periods.

    Perform hepatitis C education for GP and clinic staff at primary health services; on hepatitis testing and treatment at a service level will offer the opportunity to tailor education to the requirements of the clinic and staffing needs.Service level data will be investigated to estimate HCV targeted treatment numbers prior to intervention arms implementation. Service level data will be measured post intervention period

    Assess the effectiveness in primary health services of engaging people in hepatitis C testing, and retention throughout the care cascade whilst employing innovative techniques including incentives and peer recruitment.Service level data will be investigated to estimate HCV targeted treatment numbers prior to intervention arms implementation. Service level data will be measured post intervention period

    Outcomes

    Primary Outcome Measures

    HCV testing
    The number of participants who receive HCV testing in each of the arms
    HCV treatment
    The number of participants who start HCV treatment in each of the arms

    Secondary Outcome Measures

    Full Information

    First Posted
    February 20, 2022
    Last Updated
    May 8, 2022
    Sponsor
    Macfarlane Burnet Institute for Medical Research and Public Health Ltd
    Collaborators
    Cairns Hinterland Health Hospital and Health Services, The University of Queensland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05264558
    Brief Title
    Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30%
    Official Title
    Preparing for the Final Phase of Hepatitis C Elimination in Cairns: An Implementation Trial of a Test and Treat Approach to Reach the Final 30%.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 25, 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    May 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Macfarlane Burnet Institute for Medical Research and Public Health Ltd
    Collaborators
    Cairns Hinterland Health Hospital and Health Services, The University of Queensland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study aims to assess the impact of models of HCV care on HCV testing, treatment uptake and cure within Cairns. Point of care testing for HCV , with test and treat strategies will be offered within a primary care service.
    Detailed Description
    Available testing and treatment data will be explored pre and post the intervention period of the project within Cairns Hinterland health services that provide hepatitis C care. Test and treat strategies of the project will include: Part A: Same day test and treat clinical trial. The study will explore a 'same day test and treat' model to determine the impact on HCV treatment initiation and cure within a primary care service that recognises that they see people at risk of hepatitis C that are transient, and struggle to return to a care provider to engage in hepatitis C testing and care. HCV RNA point of care (POC) testing Epclusa (Sofosbuvir/Velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve HCV RNA result from the POC test. Part B: Refresher and clinic in reach support work Primary care service/ General practitioner education and training ~1 hour in-person training for all clinic staff on hepatitis C testing, treatment, retention in HCV care cascade. Part C: Services evaluation with incentive and peer intervention in HCV care cascade.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Model Description
    The model will permit all interventions to be explored for their impact on testing and treatment numbers in the HCV care cascade
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Test and treat
    Arm Type
    Experimental
    Arm Description
    This group will receive POC HCV viral load testing via a fingerstick using the Xpert HCV Viral load finger stick point of care test (Cepheid) in addition to the standard of care whole blood conventional laboratory based HCV PCR viral load testing. Participants who return a positive POC HCV viral load result will be provided with Epclusa on the same day as result. Follow up management will be determined by results received from standard of care blood. Service level data will be investigated to estimate HCV targeted treatment numbers prior to intervention arms implementation. Service level data will be measured post intervention periods.
    Arm Title
    General Practitioner Refresher and Clinic in reach
    Arm Type
    Other
    Arm Description
    Perform hepatitis C education for GP and clinic staff at primary health services; on hepatitis testing and treatment at a service level will offer the opportunity to tailor education to the requirements of the clinic and staffing needs.Service level data will be investigated to estimate HCV targeted treatment numbers prior to intervention arms implementation. Service level data will be measured post intervention period
    Arm Title
    Incentive and Peer intervention in HCV care cascade
    Arm Type
    Other
    Arm Description
    Assess the effectiveness in primary health services of engaging people in hepatitis C testing, and retention throughout the care cascade whilst employing innovative techniques including incentives and peer recruitment.Service level data will be investigated to estimate HCV targeted treatment numbers prior to intervention arms implementation. Service level data will be measured post intervention period
    Intervention Type
    Device
    Intervention Name(s)
    Xpert HCV Viral load finger stick point of care test (Cepheid)
    Intervention Description
    Xpert HCV VL Fingerstick is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human venous and capillary fingerstick EDTA whole blood. Appropriate pre and post testing counselling will be provided to participants.
    Intervention Type
    Drug
    Intervention Name(s)
    Epclusa 400Mg-100Mg Tablet
    Intervention Description
    Same day HCV test and treatment
    Intervention Type
    Other
    Intervention Name(s)
    Standard of care
    Intervention Description
    Clinical services will receive additional education and have the option of providing incentives to attendees of service.
    Primary Outcome Measure Information:
    Title
    HCV testing
    Description
    The number of participants who receive HCV testing in each of the arms
    Time Frame
    12 months
    Title
    HCV treatment
    Description
    The number of participants who start HCV treatment in each of the arms
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: attending primary health care service of CHHS aged 18 years or over Exclusion Criteria: only for intervention arm test and treat Known to have hepatitis B or HIV infection Known to have cirrhosis Previous treatment with direct acting antivirals Previously received interferon-based hepatitis C treatment that did not work Women that are pregnant or breastfeeding Already receiving hepatitis C treatment.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30%

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