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

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%.

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Device: Xpert HCV Viral load finger stick point of care test (Cepheid); Drug: Epclusa 400Mg-100Mg Tablet; Other: Standard of care

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.

1. HCV RNA point of care (POC) testing
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 606
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Cairns, Queensland, Australia, 4870
      • Cairns and Hinterland Hospital and Health Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test and treat; 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.	Device: Xpert HCV Viral load finger stick point of care test (Cepheid); 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.; Drug: Epclusa 400Mg-100Mg Tablet; Same day HCV test and treatment
Other: General Practitioner Refresher and Clinic in reach; 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	Other: Standard of care; Clinical services will receive additional education and have the option of providing incentives to attendees of service.
Other: Incentive and Peer intervention in HCV care cascade; 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	Other: Standard of care; Clinical services will receive additional education and have the option of providing incentives to attendees of service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV testing	The number of participants who receive HCV testing in each of the arms	12 months
HCV treatment	The number of participants who start HCV treatment in each of the arms	12 months

Collaborators and Investigators

• Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
• Collaborators: The University of Queensland; Cairns Hinterland Health Hospital and Health Services

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Anti-Infective Agents; Antiviral Agents; Sofosbuvir-velpatasvir drug combination
• Other Study ID Numbers: 16112020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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