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

NCT ID: NCT05264558

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 606 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2023-09-30

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.

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Xpert HCV Viral load finger stick point of care test (Cepheid)

Intervention Type: DEVICE

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.

Epclusa 400Mg-100Mg Tablet

Intervention Type: DRUG

Same day HCV test and treatment

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

Group Type: OTHER

Standard of care

Intervention Type: OTHER

Clinical services will receive additional education and have the option of providing incentives to attendees of service.

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

Group Type: OTHER

Standard of care

Intervention Type: OTHER

Clinical services will receive additional education and have the option of providing incentives to attendees of service.

Interventions

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.

Intervention Type: DEVICE

Epclusa 400Mg-100Mg Tablet

Same day HCV test and treatment

Intervention Type: DRUG

Standard of care

Clinical services will receive additional education and have the option of providing incentives to attendees of service.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairns Hinterland Health Hospital and Health Services

UNKNOWN

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: collaborator

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cairns and Hinterland Hospital and Health Service

Cairns, Queensland, Australia

Countries

Australia

Other Identifiers

16112020

Identifier Type: -

Identifier Source: org_study_id