Abstract
BackgroundHydroxyurea (HU) has been demonstrated to be efficacious in reducing complications in individuals with sickle cell anemia (SCA) but poor adherence is a barrier. Directly Observed Therapy (DOT) has been shown to improve adherence in various chronic diseases but there is limited data in adults with SCA.Methods and designTo examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU (mDOT-HuA) in adults with SCA at Muhimbili National Hospital in Tanzania. The mDOT-HuA study is a single centre, prospective, randomized, open label clinical trial. One-hundred individuals with SCA with haemoglobin SS genotype, aged ≥18 years, living in Dar es Salaam, able and willing to record and submit videos electronically will be included. Participants will be divided into two treatment arms; 50 in the standard monitoring (SM) arm will receive mobile phones and fixed dose HU therapy with standard monitoring; 50 in the mDOT arm will receive mobile phones, fixed dose HU therapy with standard monitoring and a mobile directly observed web based medication adherence monitoring system. The primary outcome is the proportion of participants achieving ≥80 % HU adherence compared between the two arms as assessed through medication possession ratio at the end of 3 months of treatment. REDCap, an open source software application will be used to collect data using clinical research forms. The proportions of adherence in the two arms will be compared by Fisher’s exact test. Analysis of outcomes will have performed by both the intention-to treat and per-protocol methods.DiscussionShould this study become sucessful, it will have the potential for the development of novel strategies for improving HU adherence in SCA.Trial registrationClinicalTrials.gov Identifier: NCT02844673, registered on 25tht July 2016 (retrospectively registered).
Highlights
Hydroxyurea (HU) has been demonstrated to be efficacious in reducing complications in individuals with sickle cell anemia (SCA) but poor adherence is a barrier
Should this study become sucessful, it will have the potential for the development of novel strategies for improving HU adherence in SCA
The main clinical outcome of HU use is a reduction of approximately 50 % in the incidence of vaso-occlusive crisis and acute chest syndrome, a reduction in the number of transfusions received by the patient and an improvement in survival [6, 7]
Summary
To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU (mDOT-HuA) in adults with SCA at Muhimbili National Hospital in Tanzania. The mDOT-HuA study is a single centre, prospective, randomized, open label clinical trial. Participants will be divided into two treatment arms; 50 in the standard monitoring (SM) arm will receive mobile phones and fixed dose HU therapy with standard monitoring; 50 in the mDOT arm will receive mobile phones, fixed dose HU therapy with standard monitoring and a mobile directly observed web based medication adherence monitoring system. The primary outcome is the proportion of participants achieving ≥80 % HU adherence compared between the two arms as assessed through medication possession ratio at the end of 3 months of treatment. The proportions of adherence in the two arms will be compared by Fisher’s exact test. Analysis of outcomes will have performed by both the intention-to treat and per-protocol methods
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