title: Rationale and design of mDOT-HuA study: a randomized trial to assess the effect of mobile-directly observed therapy on adherence to hydroxyurea in adults with sickle cell anemia in Tanzania.
abstract: Hydroxyurea (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.
  
  
  
  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. 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.
  
  
  
  Should this study become sucessful, it will have the potential for the development of novel strategies for improving HU adherence in SCA.
  
  
  
  ClinicalTrials.gov Identifier: NCT02844673 , registered on 25tht July 2016 (retrospectively registered).
authors.affiliation: School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania. makubi55@gmail.com.|Muhimbili Sickle cell Programme, Dar es Salaam, Tanzania. makubi55@gmail.com.|Muhimbili National Hospital, Dar es Salaam, Tanzania. makubi55@gmail.com.
authors.forename: Abel
authors.initials: A
authors.lastname: Makubi
authors.affiliation: School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
authors.forename: Philip
authors.initials: P
authors.lastname: Sasi
authors.affiliation: Muhimbili Sickle cell Programme, Dar es Salaam, Tanzania.
authors.forename: Mariam
authors.initials: M
authors.lastname: Ngaeje
authors.affiliation: Department of Medicine, Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Enrico M
authors.initials: EM
authors.lastname: Novelli
authors.affiliation: National Institute of Medical Research, Tanga, Tanzania.
authors.forename: Bruno P
authors.initials: BP
authors.lastname: Mmbando
authors.affiliation: Department of Medicine, Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.|Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Mark T
authors.initials: MT
authors.lastname: Gladwin
authors.affiliation: School of Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.|Muhimbili Sickle cell Programme, Dar es Salaam, Tanzania.|Muhimbili National Hospital, Dar es Salaam, Tanzania.|Nuffield Department of Clinical Medicine, University of Oxford, London, UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Makani
mesh_terms: D000755:Anemia, Sickle Cell / Q000188:drug therapy*; D000986:Antisickling Agents / Q000627:therapeutic use*; D040421:Cell Phone; D023801:Directly Observed Therapy; D006801:Humans; D006918:Hydroxyurea / Q000627:therapeutic use*; D055118:Medication Adherence; D016032:Randomized Controlled Trials as Topic; D013636:Tanzania; D016896:Treatment Outcome
chemical_list: D000986:Antisickling Agents; D006918:Hydroxyurea
keywords: Adherence; Hydroxyurea; Medication possession ratio; Randomized trial; Sickle cell disease