Sickle Cell Anaemia Clinical Trial
Official title:
Effect of Mobile-Directly Observed Therapy (DOT) on Adherence to Hydroxyurea Treatment in Adult HbSS Patients at Muhimbili National Hospital (MNH) in Tanzania: a Pilot Study
To examine the effect of mobile-directly observed therapy (mDOT) on adherence to HU (mDOT-HuA) adults with SCA at Muhimbili National Hospital (MNH) in Tanzania.
Background: Hydroxyurea (HU) has been demonstrated to be efficacious in reducing
complications in individuals with Sickle Cell Anemia (SCA) but poor adherence is a barrier
to improving outcomes in patients with SCA. Directly Observed Therapy (DOT) has been shown
to improve adherence in various chronic diseases but there is limited data in adults with
sickle cell anaemia (SCA).
Methods and design: To examine the effect of mobile-directly observed therapy (mDOT) on
adherence to HU (mDOT-HuA) adults with SCA at Muhimbili National Hospital (MNH) in
Tanzania.The mDOT-HuA study is single centre, prospective, randomized, open label clinical
trial. 100 participants with SCA with hemoglobin SS genotype, aged ≥18 years, living in
urban Dar es Salaam and able and willing to participate in the study. Participants will be
divided into two treatment arms; 50 in standard monitoring (SM) arm: will receive fixed dose
HU therapy with standard monitoring. 50 in treatment mDOT arm: will receive fixed dose HU
therapy with standard monitoring and a mobile direct observed web based medication adherence
monitoring system. The primary outcome is adherence to HU as defined as medication
possession ratio of ≥80 at end of 3 months of HU treatment and mDOT monitoring. Secondary
outcomes will be efficacy to HU treatment as measured through the the mean change in fetal
hemoglobin (between baseline and end of 3 months) and safety, measured as the proportion of
participants experiencing serious adverse events related to HU at week 2, 6, 10 and at the
end of 3 months.
REDCap, an open source software application will be used to collect data using clinical
research forms.
Conclusion: This project has the potential for the development of novel strategies for
improving HU adherence in SCA.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT00415727 -
Prevention Of Morbidity In Sickle Cell Disease Pilot Phase
|
Phase 2 |