Efficacy of Mobile Phone Short Message Service (SMS) Reminders on Malaria Treatment Adherence and Day 3 Post-Treatment Reviews (SMS-RES-MAL) in Kenya: A Study Protocol

BACKGROUND: Mobile phone short messaging services (SMS) have been investigated in health information reporting, provider performance, drug and diagnostic stock management and patient adherence to treatment for chronic diseases. However, their potential role in improving patients’ adherence to malaria treatment and day 3 post treatment reviews remains unclear. METHODS/DESIGN: A “proof of concept” open label randomised controlled trial will be conducted at four sites in Western Kenya. Principal research questions are: 1) Can mobile phone SMS reminders improve patient adherence to malaria treatment? 2) Can mobile phone SMS reminders improve day 3 post treatment reviews? Eligible caregivers (n=1000 per arm) of children under five years old with uncomplicated malaria will be randomly assigned (one to one) to: a) the current standard of care (provider counselling and health education); and b) the current standard of care plus SMS reminders. Within each arm, caregivers will be further randomized to three different categories. In categories 1 and 2, 300 caregivers per arm per category will be visited at home on day 1 and 2 of follow up respectively, to measure appropriate timing and adherence of the second Artemether-Lumefantrine (AL) dose and doses 3 and 4. Further, caregivers in categories 1 and 2 will be required to come to the health facility for the day 3 post treatment reviews. Finally, in category 3, 400 caregivers per arm will be visited at home on day 3 to measure adherence for the full AL course. Each category will be visited at home only once to avoid biases in the measures of adherence as a result of home consultations. Primary outcomes will be adherence to the full AL course (category 3), as well as, the proportion of patients reporting back for day 3 post treatment reviews (categories 1 and 2). The primary analysis will be intention-to-treat. Costs of the intervention will be measured over the period of the intervention, and a cost-effectiveness ratio will be estimated. DISCUSSION: If successful, evidence from this trial could improve malaria treatment adherence and offer pragmatic approaches for antimalarial drug resistance surveillance and risk mitigation in Africa. CURRENT CONTROLLED TRIALS: ISRCTN39512726