Mobile-Directly Observed Therapy on Adherence to Hydroxyurea (NCT02844673) | Clinical Trial Compass
CompletedPhase 2
Mobile-Directly Observed Therapy on Adherence to Hydroxyurea
Tanzania98 participantsStarted 2017-04-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of participants achieving ≥80% HU adherence as assessed through medication possession ratio.
Timeframe: At the end of 3 months of Hydroxyurea treatment and monitoring.
Trial details
NCT IDNCT02844673
SponsorMuhimbili University of Health and Allied Sciences