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

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ClinicalTrials.gov Identifier: NCT02844673
Recruitment Status : Enrolling by invitation
First Posted : July 26, 2016
Last Update Posted : November 23, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Sickle Cell Anaemia Drug: Hydroxyurea Device: Mobile Directly Observed Therapy Phase 4

Detailed 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Standard monitoring (SM) arm
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
Drug: Hydroxyurea
Patients will receive fixed dose Hydroxyurea therapy (15 mg/Kg/day) with standard monitoring
Experimental: mDOT arm
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.
Drug: Hydroxyurea
Patients will receive fixed dose Hydroxyurea therapy (15 mg/Kg/day) with standard monitoring
Device: Mobile Directly Observed Therapy
Mobile DOT will consist of a web based medication adherence monitoring system that includes direct video confirmation of adherence using the patient's personal cellular telephone. Patients will receive alerts on their cell phone at pre-arranged times to remind them to take their medications.
Other Name: mDOT


Outcome Measures

Primary Outcome Measures :
  1. The proportion of participants achieving ≥80% HU adherence as assessed through medication possession ratio. [ Time Frame: At the end of 3 months of Hydroxyurea treatment and monitoring. ]
    The proportion of participants achieving ≥80% HU adherence will compared between the two arms.


Secondary Outcome Measures :
  1. Efficacy of Hydroxyurea treatment as measured through the mean change in fetal hemoglobin (%), [ Time Frame: At the end of 3 months of Hydroxyurea treatment and monitoring. ]
    The mean change in fetal hemoglobin (between baseline and end of 3 months) will be compared between the two arms.

  2. The proportion of participants experiencing serious adverse events related to hydroxyurea [ Time Frame: at week 2, 6 ,10 and at the end of 3 months of Hydroxyurea treatment and monitoring. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844673


Sponsors and Collaborators
Muhimbili University of Health and Allied Sciences
University of Pittsburgh
Muhimbili National Hospital
Investigators
Study Chair: Julie Makani, PhD Muhimbili University of Health and Allied Sciences
Principal Investigator: Abel Makubi, MMed Muhimbili University of Health and Allied Sciences
Study Director: Philip Sasi, PhD Muhimbili University of Health and Allied Sciences
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ábel Makubi, Senior Lecturer, Muhimbili University of Health and Allied Sciences
ClinicalTrials.gov Identifier: NCT02844673     History of Changes
Other Study ID Numbers: MUPI-001
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes, investigators plan to share the database with one of the collaborators, University of Pittsburgh, USA

Keywords provided by Ábel Makubi, Muhimbili University of Health and Allied Sciences:
Sickle cell disease
Hydroxyurea
Adherence
randomized trial
medication possession ratio

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors