Hepatitis CNCT04510246
Link Hepatitis C Notifications to Treatment in Tasmania
A study testing Enhanced case management in people with Hepatitis C, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Enhanced case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Sep 2020to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- General Practitioners (GP) who have requested a hepatitis C test that leads to new or repeat notification to the Tasmanian Department of Health
Who cannot join
- Not based in Tasmania
- Practitioner from correctional service
- Specialist
- Nurse practitioner who initiated test
- Sexual health service doctor
- Family planning
- Trainee
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Tasmanian Department of Health
Hobart, Tasmania, 7001
Rachael L Barter
About this study
Official title: A Randomised Controlled Trial of Active Case Management to Link Hepatitis C Notifications to Hepatitis C Treatment in Tasmania
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.
- Conditions
- Hepatitis C
- Being tested
- Enhanced case management
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced case managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Enhanced case management |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The study follow up period is 12 weeks
Secondary outcomes (3)
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.
Measured: The study follow up period is 12 weeks
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.
Measured: The study follow up period is 12 weeks
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..
Measured: The study follow up period is 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start8 Sep 2020
- Primary completion1 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be a two-armed cluster randomised controlled trial with randomisation at the level of the general practitioner.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510246
- Sponsor's protocol ID
- Tas RCT HCV Notifications
- Status last verified
- Feb 2022
- First submitted
- 10 Aug 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be captured in RedCap and is de-identifiable and will be shared as a data file from the data capturing tool.
Publications
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.
PubMed 35338062
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Active Case Management to Link Hepatitis C Notifications to Hepatitis C Treatment in Tasmania
- ClinicalTrials.gov ID
- NCT04510246
- Acronym / sponsor ID
- Tas RCT HCV Notifications
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health LtdUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study will be a two-armed cluster randomised controlled trial with randomisation at the level of the general practitioner.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Enhanced case managementPractitioners 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. |
| Control | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- General Practitioners (GP) who have requested a hepatitis C test that leads to new or repeat notification to the Tasmanian Department of Health
Key exclusion criteria (7 listed)
- Not based in Tasmania
- Practitioner from correctional service
- Specialist
- Nurse practitioner who initiated test
- Sexual health service doctor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced case managementThe 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. | Behavioural | Intervention |
Primary outcome
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.
3 secondary outcomes
Proportion of people diagnosed with hepatitis C with a documented HCV RNA test result
Time frame: The study follow up period is 12 weeks
Proportion of people diagnosed with hepatitis C completing treatment work-up blood tests
Time frame: The study follow up period is 12 weeks
Proportion of people diagnosed with hepatitis C completing an appropriate course of hepatitis C treatment as prescribed
Time frame: The study follow up period is 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 35338062Marukutira 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.
- Individual participant dataSharing planned: Yes. The data will be captured in RedCap and is de-identifiable and will be shared as a data file from the data capturing tool.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced case management in people with Hepatitis C, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph Doyle, PhD (+613 9076 5436, joseph.doyle@burnet.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cases notified with hepatitis C who commence hepatitis C treatment (time frame: The study follow up period is 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04510246, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.