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Link Hepatitis C Notifications to Treatment in Tasmania

Primary Purpose

Hepatitis C

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Enhanced case management
Sponsored by
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tasmanian Department of HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Practitioners randomised to the intervention arm will receive the standard of care surveillance letter if the notification is new. Both new and repeat notifications will receive further enhanced case support during the project if required. Support can be provided at the first phone call, or if accepted and required, in a 12-week period during which the DoH health care worker can do follow-up calls with the GP or directly with the patient to inform the patient and enhance linkage back to their GP. At the end of the 12-week period, a follow-up call we be carried out for the project evaluation.

All practitioners randomised to this arm will be contacted by telephone approximately 12 weeks after an HCV notification has been made from the laboratory to the Department of Health.This is not current standard practise and will be performed by the DoH HCV health worker for the project evaluation purpose. At this phone call consent will be sought for the GP to provide information on their clinical management of the notified patient. The details of the clinical management survey are provided as Appendix B. Details provided or missing from the standard DoH surveillance form would be confirmed with the GP at this phone call. Three attempts will be made to contact the practitioner to complete the survey within a 30-day period before they are determined to be unable to be contacted.

Outcomes

Primary Outcome Measures

Proportion of cases notified with hepatitis C who commence hepatitis C treatment
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

Proportion of people diagnosed with hepatitis C with a documented HCV RNA test result
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 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 the proportion of HCV cases who complete an appropriate course of prescribed hepatitis C treatment..

Full Information

First Posted
August 10, 2020
Last Updated
February 11, 2022
Sponsor
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT04510246
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a two-armed cluster randomised controlled trial with randomisation at the level of the general practitioner.
Masking
ParticipantInvestigator
Masking Description
Given the nature of the intervention, it is impossible to blind either the health care worker or the general practitioner to allocation. However, the analysis will be conducted by an analyst at the Burnet Institute who will not have contact with the general practitioners and will be blinded to intervention allocation.
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Practitioners randomised to the intervention arm will receive the standard of care surveillance letter if the notification is new. Both new and repeat notifications will receive further enhanced case support during the project if required. Support can be provided at the first phone call, or if accepted and required, in a 12-week period during which the DoH health care worker can do follow-up calls with the GP or directly with the patient to inform the patient and enhance linkage back to their GP. At the end of the 12-week period, a follow-up call we be carried out for the project evaluation.
Arm Title
Control
Arm Type
No Intervention
Arm Description
All practitioners randomised to this arm will be contacted by telephone approximately 12 weeks after an HCV notification has been made from the laboratory to the Department of Health.This is not current standard practise and will be performed by the DoH HCV health worker for the project evaluation purpose. At this phone call consent will be sought for the GP to provide information on their clinical management of the notified patient. The details of the clinical management survey are provided as Appendix B. Details provided or missing from the standard DoH surveillance form would be confirmed with the GP at this phone call. Three attempts will be made to contact the practitioner to complete the survey within a 30-day period before they are determined to be unable to be contacted.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced case management
Intervention Description
The health care worker will offer support to the GP for all aspects of the cascade of hepatitis C care including: Further testing advice Awareness that treatment can be prescribed by the general practitioner Conducting pre-treatment work-up assessment DAA prescription guidelines, including linkage to specialist consultation Providing treatment support Advising on testing process for cure Advising on post-cure management including methods of follow-up to manage risks (e.g. harm minimisation, reducing re-infection risk, opioid substitution therapy) Linking GP to resources for patients with cirrhosis or other concerns to specialist support for ongoing management. The GP will be offered the option of the DoH specialist to contact the patient directly with the GP's consent to notify them of their result and to educate them on testing and treatment options and referral back to their GP.
Primary Outcome Measure Information:
Title
Proportion of cases notified with hepatitis C who commence hepatitis C treatment
Description
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.
Time Frame
The study follow up period is 12 weeks
Secondary Outcome Measure Information:
Title
Proportion of people diagnosed with hepatitis C with a documented HCV RNA test result
Description
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.
Time Frame
The study follow up period is 12 weeks
Title
Proportion of people diagnosed with hepatitis C completing treatment work-up blood tests
Description
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.
Time Frame
The study follow up period is 12 weeks
Title
Proportion of people diagnosed with hepatitis C completing an appropriate course of hepatitis C treatment as prescribed
Description
The the proportion of HCV cases who complete an appropriate course of prescribed hepatitis C treatment..
Time Frame
The study follow up period is 12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Doyle, PhD
Phone
+613 9076 5436
Email
joseph.doyle@burnet.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqui Richmond, PhD
Phone
+614 8866 2268
Email
Jacqui.Richmond@burnet.edu.au
Facility Information:
Facility Name
Tasmanian Department of Health
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7001
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachael L Barter

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be captured in RedCap and is de-identifiable and will be shared as a data file from the data capturing tool.
IPD Sharing Time Frame
Within 6 months of study completion
IPD Sharing Access Criteria
Full data file will be available to be shared after study completion.
Citations:
PubMed Identifier
35338062
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.
Results Reference
derived

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Link Hepatitis C Notifications to Treatment in Tasmania

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