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

Age

> 18 Years

Genotypes

SS

Phase

Phase 4

Study type

Interventional

Gender

All

Interventions

Drug

Device

Compensation

Unknown

About the 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.

participation requirements

– Age ≥18 years and living in urban Dar es Salaam

– Male or female (post-menopausal, sterile, or using an acceptable method of
contraception)

– Negative urine pregnancy test at Screening and a negative urine pregnancy test
(dipstick) prior to randomization and dosing

– Hemoglobin SS genotype

– Absolute neutrophil count >1,500/uL

– Platelet count >95,000/uL

– Serum creatinine< 100 µmol/L (1.2 mg/dL) - Alanine transaminase (ALT) less than two times the upper limit of normal - Being able and willing to record and submit videos electronically

participation restrictions

– Chronic transfusion program as defined by participating in a scheduled (pre-planned)
series of transfusions for prophylactic purposes or has a hemoglobin A level that is
>20% of the total hemoglobin

– Hemoglobin <4.0 g/dL - HIV positive - Female planning to become pregnant during the study period - Serious mental (including psychosis) or physical illness, which, in the opinion of the Investigators would compromise participation in the study (e.g. impaired mental capacity, alcoholism - Any condition which the Investigators judge to preclude safe participation in the study or to confound the evaluation of the study outcome.