Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs
Condition: Malaria; Pneumonia
MeSH terms: Malaria
Study type: Interventional

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.
    

Intervention name(s): Artemether-lumefantrine combination; amoxycillin; paracetamol; malaria rapid diagnostic test, respiratory rate timer; Artemether-lumefantrine combination
Intervention type(s): Drug; Drug; Drug; Device; Drug
Intervention description(s): 20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days; amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2; paracetamol 500mg tablet <36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days; malaria dipstick, and breath timer; 20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2
Other intervention name(s): Coartem
Intervention MeSH terms: Acetaminophen; Amoxicillin; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria ACT; Rapid; Diagnosis; Community; health; worker; Artemesinin; based; Combination; Therapy; Anti Malarial; Treatment; antibiotics