Implementation and effectiveness 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

Abstract

Background Adherence to tuberculosis (TB) treatment is challenging because of many factors. The World Health Organization has recommended the use of digital adherence monitoring technologies in its End TB Strategy. However, evidence on improving adherence is limited. EvriMED is a real-time medication-monitoring device which was found to be feasible and acceptable in a few studies in Asia. In Tanzania, however, there may be challenges in implementing evriMED due to stigmatization, network and power access, accuracy, and cost effectiveness, which may have implications for treatment outcome. 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/design 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 will be followed. TB patients in intervention clusters will take their medication from the evriMED pillbox and receive tailored feedback. We will use the ‘Stages of Change’ model, which assumes that a person has to go through the stages of pre-contemplation, contemplation, preparation, action, and evaluation to change behavior 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 Pan African Clinical Trials Registry, PACTR201811755733759 . Registered on 8 November 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3483-4) contains supplementary material, which is available to authorized users.

Technologies for Medication Adherence Monitoring and Technology Assessment Criteria: Narrative Review

“…This was evident when examining the Wisepill device’s storage capacity of 60 small-sized pills [ 1 , 27 , 39 , 41 , 46 ] compared with MedTracker’s storage capacity of a week’s worth of medication [ 44 ]. However, larger-sized devices are often described as obtrusive [ 10 , 40 , 48 ] and have increased risks to patient privacy [ 1 , 39 , 40 , 49 ], thus limiting the acceptability of the device for patient populations, particularly for those who do not wish to disclose their health status (eg, HIV positive) to others [ 39 ]. Furthermore, these devices cannot directly confirm ingestion of medications, raising concerns toward their medication adherence monitoring accuracy because potential patient behaviors, including pocket dosing and curiosity events , may impede medication adherence rate estimates [ 1 , 10 , 15 , 16 , 26 , 27 , 30 , 38 - 40 , 44 , 48 - 50 , 101 ]…”

“…However, owing to the direct ingestion of technological sensors, concerns over patient privacy and autonomy are prominent because of the invasive nature of these devices [ 9 , 13 , 20 ]. Patient reports of skin irritation caused by the external monitor [ 1 , 12 , 40 , 59 , 61 , 63 , 64 ] and the possibility of sensor retention within the body [ 15 , 60 , 64 ] are considerable limitations of these technologies, as well as potential risks to patient health and safety.…”

Evaluation of adherence monitoring system using evriMED with a differentiated response compared to standard of care among drug-sensitive TB patients in three provinces in South Africa: a protocol for a cluster randomised control trial

“…The study aims to evaluate whether implementation of medication monitors with daily remote monitoring and differentiated care is able to increase the proportion of patients with ≥ 80% adherence to drug sensitive TB treatment. Although medication monitors have been used to measure adherence in HIV treatment patients, this study is among the few studies investigating adherence using medication monitors among drug-sensitive TB patients in sub-Saharan Africa [ 17 ]. The study is also one of the first to evaluate differentiated care following information from an adherence technology.…”

Barriers and Proposed Solutions to a Successful Implementation of Pediatric Sepsis Protocols

“…Feedback has been described as good tool to improve adherence of patient and healthcare professionals to many diseases' protocols such as asthma, tuberculosis, kidney transplant, and patient safety (38)(39)(40)(41). In the study by Schramm et al, the protocol adherence rate increased from 12.7 to 53.7% after weekly feedbacks (42).…”