Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000024640
Ethics application status
Approved
Date submitted
8/12/2022
Date registered
11/01/2023
Date last updated
1/11/2023
Date data sharing statement initially provided
11/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
MOTIVATE-C: a randomised trial to evaluate the impact of financial incentives on the rate of initiation of antiviral therapy in people with hepatitis C
Scientific title
The Methodical evaluation and Optimisation of Targeted IncentiVes for Accessing Treatment of Early-stage hepatitis C (MOTIVATE-C) - A pragmatic, open-label, multi-arm Bayesian adaptive trial to evaluate the impact of financial incentives on the rate of initiation of antiviral therapy in people with hepatitis C
Secondary ID [1] 308323 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
MOTIVATE-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 328106 0
Condition category
Condition code
Infection 325160 325160 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a ‘financial incentive’ for the participants, to initiate treatment for hepatitis C, delivered within the context of a patient-support framework (treatment navigators) and provided in conjunction with/without a co-incentive payment to the participant’s nominated primary care provider.
Potential participants will be randomised to be eligible for an incentive payment on demonstrated commencement of DAA therapy ranging in value from AUD 0 to AUD 1000 (inclusive). The exact amount that participants will receive for their financial incentive will be determined by a computer generated randomisation under a response adaptive allocation scheme. Note 1: The preferred/nominated primary care provider is not a 'participant' in this project. The co-incentive payment for the provider will be allocated as part of the participant's randomisation. The provider's role is to consult with the patient, provide a pathology referral for HCV tests (if the participant is assessed to fit the criteria for HCV test) and prescribe DAA therapy (if the participant is HCV positive). The provider will not be involved in recruitment of participants and nor will they be authorised to provide a financial incentive to participants who are randomised to the intervention group. Note 2: If the participant does not have a preferred/nominated primary care provider, a default provider will be chosen for the participant. The default primary care provider will not be eligible for the randomised primary care provider payment (if any); however, they will receive a compensation payment of AUD 50.

On providing evidence of the dispensed DAA medication, the once off incentive amount for the participants (and their preferred/nominated providers if applicable) will be paid into:
• a digital debit/gift card (e-card) on their mobile device OR
• a physical debit/gift card issued to the participant.

The project navigators will be involved in: explaining to potential participants the project procedures, confirming their eligibility, confirming consent, collecting baseline data, facilitating connection of the participant to a treatment prescriber, ascertaining their HCV PCR test result and commencement of DAA therapy, facilitating follow-up appointments and final SVR testing, and ascertaining the SVR result. A navigator will be allocated once the potential participant indicates that they wish to proceed with the project and are willing to be contacted by providing their contact details. Prior to delegation and allocation of participant by the Principal investigator, all navigators will be provided with relevant guidance documentations (including the navigator manual and the project protocol) and will undergo extensive mandatory training in:
i) good clinical practice (GCP) - The navigator will undertake an online ICH-approved 'GCP in Australia' course. The online course, consisting of different modules, will take approximately 4 to 5 hours to complete.
ii) consenting practices by accredited trainers (minimum of 2 hours to complete).
iii) use of the navigator portal/database (two half-day workshops coordinated by the project manager and University of Sydney IT personnel).
The navigators will not be allocated a participant or allowed to communicate with the participant without completion of the mandatory navigator trainings.

The navigator will contact (via telephone or web video) registrants who have indicated their desire to be contacted and provided their contact details. There will be a minimum of FIVE navigator-participant meetings - to obtain consent and enrol participant, to sight and document the HCV test result and the dispensed DAA treatment, mid-treatment check-in, end-of-treatment check-in and to sight and document the SVR test. Since the participant-navigator meetings are expected to be organic and fluid, there is no specified time allotment (minimum or maximum) for each navigator-participant meeting; the time for each meeting will depend on the requirements and purpose of each meeting and will also be tailored around the convenience and needs of the participant. For example, we anticipate that the first meeting will be anywhere between 30 minutes to an hour minimum as the navigator has to not only explain the processes involved in the project, ascertain eligibility of the participant, obtain consent if participant wants to proceed and ensure that all participant queries regarding the project are satisfactorily addressed but also build a relationship with the participant; whereas the ensuing meetings may be shorter.

An independent data monitor will be employed/engaged and provided relevant access to the database to conduct audit/monitoring of the data to ensure that the data (including provision of the intervention) in this project are generated, documented, and reported in compliance with the approved protocol, the National Statement on Ethical Conduct in Human Research, ICH GCP standards and all applicable laws and regulations relating to the conduct of clinical research. Note: All delegated data monitoring staff will be qualified by education and experience to monitor the project data according to applicable Standard Operating Procedures (SOPs), University of Sydney policy and procedures, ICH Good Clinical Practice (GCP) and local requirements. The monitor(s) will also be familiar with the project protocol, navigator manual, consent form and other written information given to the participant(s).
Intervention code [1] 324771 0
Treatment: Other
Comparator / control treatment
Within the context of a patient-support framework (treatment navigators), participants in the comparator arm will not receive any incentive payment to initiate treatment for hepatitis C. The role, functions and training of the navigator for the participants in the control arm is the same as for the participants in the intervention arm (see response to 'Description of intervention(s) / exposure' section).
Control group
Active

Outcomes
Primary outcome [1] 332984 0
Initiation of Direct-acting antiviral (DAA) therapy for hepatitis C infection, as evidenced by documented receipt of a valid dispensed DAA medication.
Timepoint [1] 332984 0
Within 84 days of the participant registering in the project.
Secondary outcome [1] 415433 0
Evidence of having had a PCR test for hepatitis C infection (regardless of result). The project navigator will sight the PCR test results via videocall and document the test date and result in the database.
Timepoint [1] 415433 0
Within 84 days of the participant registering in the project.
Secondary outcome [2] 415434 0
Number of scheduled/recommended doses of DAA therapy not taken (self-reported). This will be confirmed via a text message or at the participant-navigator meeting (phone call or video call as convenient to the participant).
Timepoint [2] 415434 0
28 days after the expected end date of therapy.
Secondary outcome [3] 415435 0
Sustained virologic response (SVR), defined as a negative PCR test for hepatitis C
Timepoint [3] 415435 0
Any time from at least 28 days after completion of DAA therapy to before 365 days after the participant has registered in the project.

Eligibility
Key inclusion criteria
Adults (18 years or older) with current hepatitis C infection (by self-report) who are Medicare-eligible and living in Australia.
The co-incentive payment for the provider will be allocated as part of the participant's randomisation. The primary care provider is not a 'participant' in this project and therefore there are no specific inclusion criteria. The primary care provider can either be nominated by the participant or, in the absence of a preferred provider, can be selected by the participant from a pre-specified list of primary care providers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A potentially eligible individual will be excluded if they:
• Are already receiving DAA therapy for hepatitis C infection or have received DAA therapy in the previous 6 months
• Have previously enrolled in the project
• Are unable or unwilling to provide informed consent
• Are unable or unwilling to complete follow-up
• Are unable to commence treatment within 12 weeks of randomisation due to a contra-indication (e.g., pregnancy, or breastfeeding)

The co-incentive payment for the provider will be allocated as part of the participant's randomisation. The primary care provider is not a 'participant' in this project and therefore there are no specific exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This project has a sequential Bayesian-adaptive dose-ranging design. Initially, all participants are allocated with equal probability across the design space, which is restricted to the range 0 to 1000 AUD. At the first interim analysis following a given number of enrolments, the accrued data will be analysed and the allocation probabilities (for each dose proportional to the probability of a dose being the optimal) will be updated for the response adaptive randomisation. In order to minimise extreme allocation weights, we will restrict the upper bound to 0.9 and ensure that the control arm (zero incentive) always has a non-zero allocation equal to the maximum of the response adaptive randomisation weighting or the reciprocal of the number of active incentive doses. The randomisation thus serves to enable dose-ranging and random assignment.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/05/2023
Actual
22/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1300
Accrual to date
115
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312565 0
Government body
Name [1] 312565 0
National Health and Medical Research Council, 2020 Medical Research Future Fund (MRFF) - PPHR Initiative - Efficient use of existing medicines
Country [1] 312565 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 314174 0
None
Name [1] 314174 0
Address [1] 314174 0
Country [1] 314174 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311894 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 311894 0
Ethics committee country [1] 311894 0
Australia
Date submitted for ethics approval [1] 311894 0
14/09/2022
Approval date [1] 311894 0
25/10/2022
Ethics approval number [1] 311894 0
2022/ETH01681

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122750 0
Prof Thomas Snelling
Address 122750 0
Health and Clinical Analytics
School of Public Health, Faculty of Medicine and Health
The University of Sydney
Camperdown, NSW 2006
Country 122750 0
Australia
Phone 122750 0
+61295636886
Fax 122750 0
Email 122750 0
[email protected]
Contact person for public queries
Name 122751 0
Thomas Snelling
Address 122751 0
Health and Clinical Analytics
School of Public Health, Faculty of Medicine and Health
The University of Sydney
Camperdown, NSW 2006
Country 122751 0
Australia
Phone 122751 0
+61295636886
Fax 122751 0
Email 122751 0
[email protected]
Contact person for scientific queries
Name 122752 0
Thomas Snelling
Address 122752 0
Health and Clinical Analytics
School of Public Health, Faculty of Medicine and Health
The University of Sydney
Camperdown, NSW 2006
Country 122752 0
Australia
Phone 122752 0
+61295636886
Fax 122752 0
Email 122752 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.