Mobile-Directly Observed Therapy on Adherence to Hydroxyurea (mDOT)

Muhimbili University of Health and Allied Sciences (MUHAS)

Status and phase: Completed; Phase 2

Conditions: Sickle Cell Anaemia

Treatments: Drug: Hydroxyurea; Device: Mobile Directly Observed Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02844673

MUPI-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Standard monitoring (SM) arm

Active Comparator group

Description:

Participants will receive fixed dose hydroxyurea therapy (15 mg/Kg/day) with standard monitoring. Standard monitoring is defined as a follow-up visit two weeks after initiation of therapy and monthly follow-ups thereafter

Treatment:

Drug: Hydroxyurea

mDOT arm

Experimental group

Description:

Participants will receive fixed dose hydroxyurea therapy (15 mg/Kg/day) and Mobile Directly Observed Therapy (mDOT) consisting of a web based medication adherence monitoring system that includes direct video confirmation of adherence using the patient's personal cellular telephone. Participants will receive alerts on their cell phone at pre-arranged times to remind them to take their medications. Participants will be followed-up at two weeks after initiation of therapy and monthly thereafter.

Treatment:

Device: Mobile Directly Observed Therapy

Drug: Hydroxyurea