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Completed

NCT Number: NCT02844673

Mobile-Directly Observed Therapy on Adherence to Hydroxyurea

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.

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Key information

Conditions

Sickle Cell Anaemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, 11101, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydroxyurea

Drug

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

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.

Other names: mDOT

Primary outcomes

  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 outcomes

  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 (SAE) related to hydroxyurea

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

    The overall proportion of participants experiencing SAE during the 3 months of Hydroxyurea treatment will be evaluated as a measure of the safety of treatment with Hydroxyurea

Other outcomes

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

    Time frame: At the end of 3 months Hydroxyurea treatment and monitoring

    The incidence during 3 months of treatment will be compared with the incidence during pre-treatment period

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

    Time frame: At the end of 3 months Hydroxyurea treatment and monitoring

    The level of leucopenia in relation to incidence rate of fever during 3 months of treatment with be compared with that during the pre-treatment period

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

    Time frame: At the end of 3 months Hydroxyurea treatment and monitoring

    The mean change in estimated glomerular filtration rate will be evaluated as an indicator of deteriorating renal function after Hydroxyurea exposure

  4. Mean change in the level of Lactate Dehydrogenase (LDH) from baseline

    Time frame: At the end of 3 months Hydroxyurea treatment and monitoring

    Serum LDH level (U/L) is usually elevated in sickle cell anemia indicating hemolysis. A decrease in the level of LDH will be considered favorable effect of Hydroxyurea

  5. Mean change in reticulocyte count from baseline

    Time frame: At the end of 3 months Hydroxyurea treatment and monitoring

    Reticulocyte count is usually increased in sickle cell anemia, indicating of hemolysis (a decrease in reticulocyte count % will be considered favorable effect of Hydroxyurea)

Sponsors and collaborators

Lead sponsor

Muhimbili University of Health and Allied Sciences

Other

Collaborators

  • Muhimbili National Hospital
  • University of Pittsburgh

Registry information

Official study 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

Acronym: mDOT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2016
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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