Mobile-Directly Observed Therapy on Adherence to Hydroxyurea (NCT02844673) | Clinical Trial Compass
CompletedPhase 2
Mobile-Directly Observed Therapy on Adherence to Hydroxyurea
Tanzania98 participantsStarted 2017-04-28
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
What they're measuring
1
The proportion of participants achieving ≥80% HU adherence as assessed through medication possession ratio.
Timeframe: At the end of 3 months of Hydroxyurea treatment and monitoring.
Trial details
NCT IDNCT02844673
SponsorMuhimbili University of Health and Allied Sciences