Effectiveness and implementation of evriMED with short messages service (SMS) reminders and tailored feedback compared to standard care on adherence to treatment among tuberculosis patients in Kilimanjaro, Tanzania: proposal for a cluster Randomized Controlled Trial SMS reminders and tailored feedback through evriMED and adherence to TB treatment

Abstract

Background: Adherence to Tuberculosis (TB) treatment is challenging because of many factors. The World Health Organization (WHO) has recommended the use of digital adherence monitoring technologies in its End-TB-strategy. However, there is paucity on its evidence in improving adherence. EvriMED is a real time medication monitoring (RTMM) device which was found feasible and acceptable in few studies in Asia. However, in Tanzania, there may be challenges in implementing evriMED due to stigmatization, network and power access, accuracy and cost effectiveness which may have an implication for treatment outcomes. We propose a pragmatic cluster randomized trial, to investigate the effectiveness of evriMED with reminder cues and tailored feedback on adherence to TB treatment in Kilimanjaro, Tanzania. Methods: We will create clusters in Kilimanjaro based on level of health care facility. Clusters will be randomized in an intervention arm, where evriMED will be implemented or a control arm, where standard practice Directly Observed Treatment (DOT) will be followed. TB patients in intervention clusters will take their medication from the evriMED pillbox and receive tailored feedback. We will use the ‘Stages­of-change’­model, which assumes that a person has to go through the stages of pre-contemplation, contemplation, preparation, action and evaluation to change behaviour for tailored feedback on adherence reports from the device. Discussion: If the intervention shows a significant effect on adherence and the devices are accepted, accurate and sustainable, the intervention can be scaled up within the National Tuberculosis Programmes. Trial registration: PACTR201811755733759 at 8 November 2018 at https://pactr.samrc.ac.za/