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Link Hepatitis C Notifications to Treatment in Tasmania

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510246
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Behavioral: Enhanced case management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be a two-armed cluster randomised controlled trial with randomisation at the level of the general practitioner.
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Active Case Management to Link Hepatitis C Notifications to Hepatitis C Treatment in Tasmania
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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.
Behavioral: Enhanced case management

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.


No Intervention: Control
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.



Primary Outcome Measures :
  1. Proportion of cases notified with hepatitis C who commence hepatitis C treatment [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510246


Contacts
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Contact: Joseph Doyle, PhD +613 9076 5436 joseph.doyle@burnet.edu.au
Contact: Jacqui Richmond, PhD +614 8866 2268 Jacqui.Richmond@burnet.edu.au

Sponsors and Collaborators
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Department of Health and Human Services
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Responsible Party: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
ClinicalTrials.gov Identifier: NCT04510246    
Other Study ID Numbers: Tas RCT HCV Notifications
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections