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| Name | Class |
|---|---|
| Makerere University | OTHER |
| Ministry of Health, Uganda | OTHER_GOV |
| Navrongo Health Research Centre, Ghana | OTHER |
| National Malaria Research and Training Centre, Burkina Faso |
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This study is to assess the value of incorporating a malaria RDT based strategy in HMM. The primary activity of the study wil be a two armed cluster randomised trial in two study sites in Uganda, one in Ghana and one in Burkina Faso. One of the Uganda sites is highly endemic and the other meso-endemic for malaria. In one arm the children will be treated presumptively for malaria with ACT (control arm) and the other arm the children will receive ACT only when they have a positive RDT result (implementation arm). The children in the implementation arm will also receive antibiotics if they have a raised respiratory rate. The primary outcome will be the recovery rate in the intervention arm compared to that of the control arm on Day 3. In addition, an acceptability assessment of RDTs in the community will be undertaken both before and after the intervention trial and a cost-effectiveness analysis of the RDT strategy will also be completed. For a sub-sample, microscopy slides will also be taken on Day 0 to demonstrate comparable levels of endemicity in control and intervention groups. These activities will be carried out over a two year period.
This is an open, cluster randomised multicentre two arm trial in the three countries of Burkina Faso, Ghana and Uganda. Clusters are villages (catchment populations) of individual community health workers (CHWs). Within the study areas, clusters that are more than 5 km from a designate health facility where CHWs referred cases for special care will be excluded. A cluster randomized design was chosen over an individually randomized design to reduce contamination, facilitate supervision, reduce costs, and to ensure that the CHWs maintained the correct treatments based on the tests in the Intervention arm and the presumptive treatment in the Control arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT, antibiotic, paracetamol | Experimental | CHWs will test children with acute febrile illness for malaria using RDTs, and for pneumonia by counting their respiratory rate with RRTs. Treatment will then be provided on the basis of the test results, in line with national guidelines. Children with a positive RDT will receive artemether-lumefantrine in Burkina Faso and Uganda, and artesunate-amodiaquine in Ghana. Children with a cough and a high respiratory rate will receive amoxicillin in Ghana and Uganda, and cotrimoxazole in Burkina Faso. Additionally, paracetamol (PCT) will be provided to all children with an axillary temperature > 38.5°C. |
|
| Presumptive fever management | No Intervention | Presumptive treatment of malaria with ACTs. No antibiotic treatment available |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artemether-lumefantrine combination | Drug | 20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery rate from fever at Day 3 | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| use of antimalarial and antibiotic drugs by community health workers | After patient enrollment | |
| Recovery rate from fever at Day 7 | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis Bajunirwe, MBChB PhD | Mbarara University of Science and Technology | Study Director |
| George Pariyo, MB ChB, PhD | Makerere University | Study Director |
| James Tibenderana, MB ChB, PhD | Malaria Consortium | Principal Investigator |
| Alfred Tiono, PhD | National Malaria Research and Training Center, Burkina Faso | Principal Investigator |
| Thomas Anyorigiya, MSc | Navrongo Health Research Centre, Ghana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapone Site | Saponé | Burkina Faso | ||||
| Kassena Nankana Site |
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| UNKNOWN |
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|
| amoxycillin | Drug | amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2 |
|
| paracetamol | Drug | paracetamol 500mg tablet <36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days |
|
| malaria rapid diagnostic test, respiratory rate timer | Device | malaria dipstick, and breath timer |
|
| Artemether-lumefantrine combination | Drug | 20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2 |
|
| Kassane |
| Ghana |
| Iganga Site | Iganga | Uganda |
| Mbarara Site | Mbarara | Uganda |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011014 | Pneumonia |
| D005215 | Fasting |
| D004194 | Disease |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077611 | Artemether, Lumefantrine Drug Combination |
| D000658 | Amoxicillin |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| 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 |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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