Clinical trial NCT04510246: Link Hepatitis C Notifications to Treatment in Tasmania
Official title: A Randomised Controlled Trial of Active Case Management to Link Hepatitis C Notifications to Hepatitis C Treatment in Tasmania
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C
Lead sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2020-08-12
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a two-armed cluster randomised controlled trial with randomisation at the level of the general practitioner.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of cases notified with hepatitis C who commence hepatitis C treatment
timeFrame: The study follow up period is 12 weeks
Secondary outcomes:
measure: Proportion of people diagnosed with hepatitis C with a documented HCV RNA test result
timeFrame: The study follow up period is 12 weeks
measure: Proportion of people diagnosed with hepatitis C completing treatment work-up blood tests
timeFrame: The study follow up period is 12 weeks
measure: Proportion of people diagnosed with hepatitis C completing an appropriate course of hepatitis C treatment as prescribed
timeFrame: The study follow up period is 12 weeks
Other outcomes:
Locations:
city: Hobart
country: Australia
facility: Tasmanian Department of Health
state: Tasmania
Study officials:
References:
citation: Marukutira T, Moore KP, Hellard M, Richmond J, Turner K, Pedrana AE, Melody S, Johnston FH, Owen L, Van Den Boom W, Scott N, Thompson A, Iser D, Spelman T, Veitch M, Stoove MA, Doyle J. Randomised controlled trial of active case management to link hepatitis C notifications to treatment in Tasmania, Australia: a study protocol. BMJ Open. 2022 Mar 25;12(3):e056120. doi: 10.1136/bmjopen-2021-056120.