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Sickle Cell AnaemiaPhase 2mDOTNCT02844673

Mobile-Directly Observed Therapy on Adherence to Hydroxyurea

A Phase 2 study testing Hydroxyurea and Mobile Directly Observed Therapy in people with Sickle Cell Anaemia, run by Muhimbili University of Health and Allied Sciences at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Sickle Cell Anaemia
What is being tested?
Hydroxyurea and Mobile Directly Observed Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteTanzania
Study dates
28 Apr 2017to 18 May 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Tanzania1 site

  • Muhimbili University of Health and Allied Sciences

    Dar es Salaam, 11101

Other trials in Tanzania

About this study

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

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.

Read the 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.

Being tested
Hydroxyurea, Mobile Directly Observed Therapy
Keywords
Sickle cell disease, Hydroxyurea, Adherence, randomized trial, medication possession ratio
Medical subject headings
Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HydroxyureaDrug

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

  • Mobile Directly Observed TherapyDevice

    Also called mDOT

    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.

Study groups in NCT02844673
Study groupRoleWhat they receive
Standard monitoring (SM) armActive comparatorParticipants 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
Receives: Drug: Hydroxyurea
mDOT armExperimentalParticipants 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.
Receives: Drug: Hydroxyurea; Device: Mobile Directly Observed Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

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

    The mean change in fetal hemoglobin (between baseline and end of 3 months) will be compared between the two arms.

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

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

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2016 (estimated)
  2. Study start28 Apr 2017
  3. Primary completion28 Jan 2018
  4. Study completion18 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02844673
Sponsor's protocol ID
MUPI-001
Acronym
mDOT
Status last verified
Jun 2024
First submitted
18 Jul 2016
Last updated
12 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Yes, investigators plan to share the database with one of the collaborators, University of Pittsburgh, USA

Publications

  • 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.

    PubMed 27756209

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydroxyurea and Mobile Directly Observed Therapy in people with Sickle Cell Anaemia, run by Muhimbili University of Health and Allied Sciences at 1 site in Tanzania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02844673, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.

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