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 Contr

Marion Sumari-de Boer Kilimanjaro Clinical Research Institute m.sumari@kcri.ac.tzCorresponding Author ORCiD: https://orcid.org/0000-0002-5433-0406 Francis M Pima Kilimanjaro Clinical Research Institute Kennedy M Ngowi Kilimanjaro Clinical Research Institute Geoffrey M Chelangwa National Tuberculosis and Leprosy Programme Benson Mtesha Kilimanjaro Clinical Research Institute Hadija H Semvua Kilimanjaro Clinical Research Institute Stella Mpagama Kibong'oto Infectious Diseases Hospital Blandina T Mmbaga Kilimanjaro Clinical Research Institute Pythia T Nieuwkerk UMC Amsterdam - Location AMC Rob E Aarnoutse Radboud UMC
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BackgroundAdherence to TB treatment is challenging because of many factors. WHO has recommended the useof digital adherence monitoring technologies in its End-TB-strategy. However, there is paucity on itsevidence in improving adherence. EvriMED a real time medication monitoring (RTMM) which wasfound feasible and acceptable in few studies in Asia. However, in Tanzania, there may be challengesin implementing evriMED due to stigmatization, network and power access, accuracy and costeffectiveness which may have an implication for treatment outcomes. We propose a pragmatic clusterrandomized trial, to investigate the effectiveness of evriMED with reminder cues and tailoredfeedback on adherence to TB treatment in Kilimanjaro, Tanzania.

MethodsWe will create clusters in Kilimanjaro based on level of health care facility. Clusters will berandomized in an intervention arm, where evriMED will be implemented or a control arm, wherestandard practice DOTs will be followed. TB patients in intervention clusters will take their medicationfrom 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 behaviour for tailored feedback on adherence reportsfrom the device.DiscussionIf the intervention shows a significant effect on adherence and the devices are accepted, accurateand sustainable, the intervention can be scaled up within the National Tuberculosis Programmes.