Link Hepatitis C Notifications to Treatment in Tasmania

Not Applicable

• Conditions: Hepatitis C

• Registration Number: NCT04510246
• Lead Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Brief Summary

This project will utilise the notification process as a point of intervention to work with primary practitioners (GP) by contacting them directly when a notification of hepatitis C exposure is received by the Tasmanian department of Health (DoH). A designated role will exist within DoH of a specialist HCV health worker to contact GPs to provide supported assistance in the process of the follow up hepatitis C diagnoses with patients. The study will evaluate whether active follow up of providers with enhanced case management is effective in having patients linked to hepatitis C treatment compared to current standard of care of surveillance for new notifications. The study will also compare the cost-effectiveness of this approach compared to current standard of care after one of their patients is notified with a positive hepatitis C antibody result.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Study Start: 2020-09-08
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Primary Completion: 2022-03-01
• Last Update Posted: 2022-03-02
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• General Practitioners (GP) who have requested a hepatitis C test that leads to new or repeat notification to the Tasmanian Department of Health

Exclusion Criteria

• Not based in Tasmania
• Practitioner from correctional service
• Specialist
• Nurse practitioner who initiated test
• Sexual health service doctor
• Family planning
• Trainee

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of cases notified with hepatitis C who commence hepatitis C treatment	The study follow up period is 12 weeks	The primary outcome will be the proportion of cases notified with hepatitis C who commence hepatitis C treatment within 12 weeks of initial contact. This will be assessed using the information provided by practitioners at the 12-week follow-up phone call and will be compared across the two arms.

Secondary Outcome Measures

Name	Time	Method
Proportion of people diagnosed with hepatitis C with a documented HCV RNA test result	The study follow up period is 12 weeks	The the proportion of cases notified with hepatitis C with documented HCV RNA results within 12 weeks of initial contact. This will be assessed using lab data and information provided by practitioners.
Proportion of people diagnosed with hepatitis C completing treatment work-up blood tests	The study follow up period is 12 weeks	The the proportion of HCV RNA positive cases who completed treatment work up blood tests within 12 weeks of initial contact. This will be assessed using lab data and information provided by practitioners.
Proportion of people diagnosed with hepatitis C completing an appropriate course of hepatitis C treatment as prescribed	The study follow up period is 12 weeks	The the proportion of HCV cases who complete an appropriate course of prescribed hepatitis C treatment..

Trial Locations

Locations (1)

Tasmanian Department of Health; 🇦🇺 Hobart, Tasmania, Australia