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| Name | Class |
|---|---|
| London School of Hygiene and Tropical Medicine | OTHER |
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Effective use of Rapid Diagnostic Test (RDT) and artemisinin-based combination therapy (ACT) depends on the accuracy and safety of RDT based treatment practices and on factors related to the health delivery system. We propose to study the accuracy and safety of RDT based diagnosis and treatment of febrile illness, health system determinants of effective use of RDTs and the public health outcomes of RDT based ACT for malaria.A cluster randomised trial of RDT based versus clinical judgment based treatment of febrile illness on the incidence of malaria in <48 month old children will be conducted. Health Centres will be randomly allocated to RDT based treatment or clinical judgment based treatment arm and children under 2years of age from the catchment area of each health centre will be followed for 2 years. The cost effectiveness of RDT based approach will be compare with the clinical judgement based treatment.
Two-stage, four component study Stage I - Component A: Accuracy of RDT and the outcome of treatment based on RDT results Primary outcome:What is the sensitivity and specificity of Paracheck cassettes in Ghana to diagnose malaria?
Stage 1 - Component B: delivery system determinants of effective RDT based ACT Primary outcome: What are the delivery system determinants of effective RDT based ACT?
Stage 2 - Component A: effects of restricted use of ACTs based on RDT results: a randomised controlled trial Primary outcome: Incidence of malaria (fever + any level of parasite density) in < 48 month-old children
Stage 2 - component B: Cost effectiveness analysis:
Primary outcome:What is the cost effectiveness of RDT based ACT for treatment of children under 4 years compared with ACT based on clinical judgement?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDT+ACT group | Experimental | RDT+ACT group (ACT offered to RDT positive cases only) |
|
| Clinical judgement+ACT group | Active Comparator | Clinical judgement+ACT group (ACT offered to all suspected cases of malaria by clinical judgement) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDT | Device | Study children attending RDT+ACT HCs with a febrile illness will be tested with an RDT to confirm malaria and treated with ACT only if they have a positive test for malaria parasite. However if there are signs suggestive of other co-morbidities they will be treated with appropriate medicines in addition to AS+AQ. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of malaria (fever + any level of parasite density) in < 48 month-old children (Stage 2, Component A) | Three years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe anaemia (Hb <8 g/dl) in < 48 month old children | Three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank E Baiden | Kintampo Health Research Center | Principal Investigator |
| Jayne Webster | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Christopher Whitty | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Seth Owusu-Agyei | Kintampo Health Research Center | Principal Investigator |
| Daniel Chandramohan | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Jane Bruce | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kintampo Health Research Center | Kintampo | BAR | 200 | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27695130 | Derived | Tawiah T, Hansen KS, Baiden F, Bruce J, Tivura M, Delimini R, Amengo-Etego S, Chandramohan D, Owusu-Agyei S, Webster J. Cost-Effectiveness Analysis of Test-Based versus Presumptive Treatment of Uncomplicated Malaria in Children under Five Years in an Area of High Transmission in Central Ghana. PLoS One. 2016 Oct 3;11(10):e0164055. doi: 10.1371/journal.pone.0164055. eCollection 2016. | |
| 27055275 |
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|
| Clinical Judgement as basis for treatment of malaria with ACT | Other | Study children attending RDT+ACT HCs with a febrile illness will be tested with an RDT to confirm malaria and treated with ACT only if they have a positive test for malaria parasite. However if there are signs suggestive of other co-morbidities they will be treated with appropriate medicines in addition to AS+AQ. |
|
| Derived |
| Baiden F, Bruce J, Webster J, Tivura M, Delmini R, Amengo-Etego S, Owusu-Agyei S, Chandramohan D. Effect of Test-Based versus Presumptive Treatment of Malaria in Under-Five Children in Rural Ghana--A Cluster-Randomised Trial. PLoS One. 2016 Apr 7;11(4):e0152960. doi: 10.1371/journal.pone.0152960. eCollection 2016. |
| 22514617 | Derived | Baiden F, Webster J, Tivura M, Delimini R, Berko Y, Amenga-Etego S, Agyeman-Budu A, Karikari AB, Bruce J, Owusu-Agyei S, Chandramohan D. Accuracy of rapid tests for malaria and treatment outcomes for malaria and non-malaria cases among under-five children in rural Ghana. PLoS One. 2012;7(4):e34073. doi: 10.1371/journal.pone.0034073. Epub 2012 Apr 13. |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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