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

NCT05264558 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: 16112020
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Test and treat

EXPERIMENTAL

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); Drug: Epclusa 400Mg-100Mg Tablet

General Practitioner Refresher and Clinic in reach

OTHER

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

Incentive and Peer intervention in HCV care cascade

OTHER

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

Interventions

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

Test and treat

Epclusa 400Mg-100Mg Tablet DRUG

Same day HCV test and treatment

Test and treat

Standard of care OTHER

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

General Practitioner Refresher and Clinic in reach; Incentive and Peer intervention in HCV care cascade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cairns and Hinterland Hospital and Health Service

Cairns, Queensland, 4870, Australia

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination; Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The model will permit all interventions to be explored for their impact on testing and treatment numbers in the HCV care cascade

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 3, 2022
• Study Start: July 25, 2022
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)