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

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Status and phase: Completed; Phase 4

Conditions: Hepatitis C

Treatments: Other: Standard of care; Device: Xpert HCV Viral load finger stick point of care test (Cepheid); Drug: Epclusa 400Mg-100Mg Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05264558

16112020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 606 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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606 participants in 3 patient groups

Test and treat

Experimental group

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.

Treatment:

Drug: Epclusa 400Mg-100Mg Tablet

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

General Practitioner Refresher and Clinic in reach

Other group

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

Treatment:

Other: Standard of care

Incentive and Peer intervention in HCV care cascade

Other group

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

Treatment:

Other: Standard of care