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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| Muhimbili National Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxyurea | Drug | Patients will receive fixed dose Hydroxyurea therapy (15 mg/Kg/day) with standard monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of 3 months of Hydroxyurea treatment and monitoring. |
| The proportion of participants experiencing serious adverse events (SAE) related to hydroxyurea |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of laboratory adverse events, fever and other sickle cell anemia symptoms | The incidence during 3 months of treatment will be compared with the incidence during pre-treatment period | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhimbili University of Health and Allied Sciences | Dar es Salaam | 11101 | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27756209 | Derived | 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. |
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Yes, investigators plan to share the database with one of the collaborators, University of Pittsburgh, USA
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D006918 | Hydroxyurea |
| ID | Term |
|---|---|
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| 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. |
|
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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 |
| at week 2, 6 ,10 and at the end of 3 months of 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 |
| At the end of 3 months Hydroxyurea treatment and monitoring |
| Mean change in estimated glomerular filtration rate as a measure of kidney function | The mean change in estimated glomerular filtration rate will be evaluated as an indicator of deteriorating renal function after Hydroxyurea exposure | At the end of 3 months Hydroxyurea treatment and monitoring |
| Mean change in the level of Lactate Dehydrogenase (LDH) from baseline | 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 | At the end of 3 months Hydroxyurea treatment and monitoring |
| Mean change in reticulocyte count from baseline | Reticulocyte count is usually increased in sickle cell anemia, indicating of hemolysis (a decrease in reticulocyte count % will be considered favorable effect of Hydroxyurea) | At the end of 3 months Hydroxyurea treatment and monitoring |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |