Malaria, Pneumonia
Conditions
Keywords
Malaria ACT, Rapid, Diagnosis, Community, health, worker, Artemesinin, based, Combination, Therapy, Anti Malarial, Treatment, antibiotics
Brief summary
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.
Detailed description
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.
Interventions
20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days
DRUGamoxycillin
amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2
DRUGparacetamol
paracetamol 500mg tablet \<36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days
DEVICEmalaria rapid diagnostic test, respiratory rate timer
malaria dipstick, and breath timer
Sponsors
Makerere University
Ministry of Health, Uganda
Navrongo Health Research Centre, Ghana
National Malaria Research and Training Centre, Burkina Faso
Mbarara University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
* Children between 4-59 months of age with a history of fever in the last 24 hours presenting to the community medicine distributor
Exclusion criteria
* Children classified as having severe illness according to IMCI guidelines. Children suffering from Chronic disease(s), those with reported anti malarial or antibiotic treatment (intervention) arm in previous two weeks and those whose caregivers refuse to consent to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery rate from fever at Day 3 | Day 3 |
Secondary
| Measure | Time frame |
|---|---|
| use of antimalarial and antibiotic drugs by community health workers | After patient enrollment |
| Recovery rate from fever at Day 7 | Day 7 |
Countries
Burkina Faso, Ghana, Uganda
Outcome results
None listed