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| Name | Class |
|---|---|
| National Malaria Control Program | OTHER |
| Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation | UNKNOWN |
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The aim of this study is to address this gap in knowledge by measuring the level of patient adherence to co-formulated amodiaquine and artesunate (AQ-AS) compared to artemether-lumefantrine (AL) under routine conditions in Sierra Leone and explore the key factors that influence adherence. This will be addressed through a mixed methods study that will provide not only a measurement of adherence ACTs and malaria test results, but will also provide contextual information in order to better understand factors that affect adherence. Data will be collected through a series of interviews with health workers and parents/caregivers and through observations of patient-provider consultations.
The first stage of the study begins with semi-structured interviews and observations of patients/caretakers' consultations with health workers and will look at how health workers diagnose and treat malaria. This will be followed by short exit interviews at the health facility with caregivers to assess patient satisfaction with services, as well as to test the consistency between the data obtained through structured observations and the exit interviews.
Follow-up surveys at the homes of patients will be used to measure and compare the adherence of participants to two different ACTs (AQAS and AL) formulations and potential factors that affect adherence. Additionally, data will be collected using in-depth interviews to collect supplementary information in order to discover, in more detail, factors that may affect behavioral choices and/or attitudes with regard to adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| co-formulated Amodiaquine-Artesunate | Active Comparator | Sanofi Coarsucam Infant dose (2-12 months/4.5-8kg), amodiaquine:67.5mg/artesunate 25mg; 1 tablet once a day for 3 days. Sanofi Coarsucam Young Child (13-59 months/9-17kg), amodiaquine: 136mg/artesunate 50mg; 1 tablet once a day for 3 days. |
|
| artemether-lumefantrine | Active Comparator | Novartis coartem infant dose (2-11 months/5-14kg), artemether 20mg/lumefantrine 120mg; 1 tablet twice a day for 3 days. Novartis coartem child dose (12-59 months/15-24kg), artemether 20mg/lumefantrine 120mg; 2 tablets twice a day for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amodiaquine-artesunate (AQAS) fixed-dose | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Adherence is measured on the day following the last day of treatment. Adherence is defined as taking all of the prescribed dose at the correct time. | Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Banek | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Brook Health Center | Freetown | Sierra Leone | ||||
| Ross Road Health Facility |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29866192 | Derived | Banek K, Webb EL, Smith SJ, Chandramohan D, Staedke SG. Adherence to treatment with artemether-lumefantrine or amodiaquine-artesunate for uncomplicated malaria in children in Sierra Leone: a randomized trial. Malar J. 2018 Jun 4;17(1):222. doi: 10.1186/s12936-018-2370-x. |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| C515299 | amodiaquine, artesunate drug combination |
| D000077611 | Artemether, Lumefantrine Drug Combination |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
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| Artemether-lumefantrine combination (AL) dispersable | Drug |
|
|
| Freetown |
| Sierra Leone |
| D000079426 |
| Vector Borne Diseases |
| D007287 |
| Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |