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

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).