Mobile-Directly Observed Therapy on Adherence to Hydroxyurea

NCT02844673 | Completed Phase 2

• 1 other identifier: MUPI-001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Anaemia

Keywords

Sickle cell disease; Hydroxyurea; Adherence; randomized trial; medication possession ratio

Outcome Measures

Primary Outcomes (1)

• The proportion of participants achieving ≥80% HU adherence as assessed through medication possession ratio.

  The proportion of participants achieving ≥80% HU adherence will compared between the two arms.

  At the end of 3 months of Hydroxyurea treatment and monitoring.

Secondary Outcomes (2)

• Efficacy of Hydroxyurea treatment as measured through the mean change in fetal hemoglobin (%),

  At the end of 3 months of Hydroxyurea treatment and monitoring.

• The proportion of participants experiencing serious adverse events (SAE) related to hydroxyurea

  at week 2, 6 ,10 and at the end of 3 months of Hydroxyurea treatment and monitoring.

Other Outcomes (5)

• Incidence of laboratory adverse events, fever and other sickle cell anemia symptoms

  At the end of 3 months Hydroxyurea treatment and monitoring

• Level of leucopenia in relation to incidence rates of fever as indicator of possible infection

  At the end of 3 months Hydroxyurea treatment and monitoring

• Mean change in estimated glomerular filtration rate as a measure of kidney function

  At the end of 3 months Hydroxyurea treatment and monitoring

Study Arms (2)

Standard monitoring (SM) arm

ACTIVE COMPARATOR

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

mDOT arm

EXPERIMENTAL

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; Device: Mobile Directly Observed Therapy

Interventions

Hydroxyurea DRUG

Patients will receive fixed dose Hydroxyurea therapy (15 mg/Kg/day) with standard monitoring

Standard monitoring (SM) arm; mDOT arm

Mobile Directly Observed Therapy DEVICE

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.

Also known as: mDOT

mDOT arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muhimbili University of Health and Allied Sciences: lead
• University of Pittsburgh: collaborator
• Muhimbili National Hospital: collaborator

Study Sites (1)

Muhimbili University of Health and Allied Sciences

Dar es Salaam, 11101, Tanzania

Location

Related Publications (1)

• Makubi A, Sasi P, Ngaeje M, Novelli EM, Mmbando BP, Gladwin MT, Makani J. Rationale and design of mDOT-HuA study: a randomized trial to assess the effect of mobile-directly observed therapy on adherence to hydroxyurea in adults with sickle cell anemia in Tanzania. BMC Med Res Methodol. 2016 Oct 18;16(1):140. doi: 10.1186/s12874-016-0245-9.

  PMID: 27756209 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Hydroxyurea

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals

Study Officials

• Julie Makani, PhD

  Muhimbili University of Health and Allied Sciences

  STUDY CHAIR

• Abel Makubi, MMed

  Muhimbili University of Health and Allied Sciences

  PRINCIPAL INVESTIGATOR

• Philip Sasi, PhD

  Muhimbili University of Health and Allied Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 26, 2016
• Study Start: April 28, 2017
• Primary Completion: January 28, 2018
• Study Completion: May 18, 2018
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

TA (1)