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

Hepatitis C Clinical Trial

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%.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264558
• Other study ID #: 16112020
• Status: Completed
• Phase: Phase 4
• Start date: July 25, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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

Locations

Country	Name	City	State
Australia	Cairns and Hinterland Hospital and Health Service	Cairns	Queensland

Sponsors (3)

Lead Sponsor	Collaborator
Macfarlane Burnet Institute for Medical Research and Public Health Ltd	Cairns Hinterland Health Hospital and Health Services, The University of Queensland

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV testing	The number of participants who receive HCV testing in each of the arms	12 months
Primary	HCV treatment	The number of participants who start HCV treatment in each of the arms	12 months