Mobile-Directly Observed Therapy on Adherence to Hydroxyurea

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Muhimbili University of Health and Allied Sciences
• Collaborators: Muhimbili National Hospital; University of Pittsburgh
• Treatments: Hydroxyurea

Criteria

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.