Mobile telephone contingency management to encourage adherence to supervised medication among individuals most at risk of non-adherence to opioid agonist treatment: a study protocol for a feasibility study (TIES2)

Background
Supervision of opioid agonist treatment (OAT) ensures that individuals take their correct daily dose to minimise withdrawal and craving, safeguard against diversion and overdose, and receive optimal benefit from OAT. There is an urgent need to develop effective interventions to increase medication adherence and technological solutions to streamline communication between pharmacies and prescribers. The authors have developed technology to deliver contingency management (CM) remotely by mobile telephone (mCM) and alert prescribers of missed doses. In a previous feasibility study, the authors found mCM was feasible to deliver and acceptable to patients, prescribers, and pharmacists but encountered difficulty recruiting patients starting methadone treatment. Since COVID-19, supervision guidelines have changed to focus on patients at risk of/not adhering to their medication. This study aims to assess the feasibility of conducting a future confirmatory trial to assess the clinical and cost-effectiveness of mCM to encourage adherence with supervised methadone or buprenorphine. It will use broader eligibility criteria, including patients receiving buprenorphine, and target a revised group of serial re-starters.
Methods
Using a cluster randomised design, three drug services will be randomised 1:1:1 and 20 patients, attending seven pharmacies linked to each service, will be recruited (i.e. a total of N = 60). Each drug service providing supervised medication will be randomly allocated to deliver: (i) telephone-delivered text-message reinforcement with modest financial incentives; (ii) telephone-delivered text-message reminders; or (iii) no telephone text-messages. Prescribers will receive reports of patient attendance. Feasibility will be determined based on four progression criteria: the number of patients enrolled, the percentage of screened patients who are eligible, adherence to the telephone system, based on matches between sign-in at the pharmacy and pharmacy dispensing records and follow-up rates. We will also undertake qualitative assessments of clinicians' perspectives on the revised eligibility criteria undertaken.
Discussion
This study will assess the feasibility of using mCM to target a clinically important group of patients non-adhering to their supervised medication. In the future, and if effective, mCM will encourage medication adherence among patients, enabling them to achieve an optimum dose and full benefit from OAT.
Trial registration
ISRCTN33965312 (26/06/2023). This manuscript was submitted on February 27th, 2024. While recruitment was due to end on February 29th, we recruited our last patient on February 12th. The last patient/last visit took place on May 2nd, 2024.

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