NCT00720811

Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,456 (actual)
• Sponsor: Mbarara University of Science and Technology · Academic / Other
• Sex: All
• Age: 4 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Malaria
• Pneumonia

Interventions

Type	Name	Description
DRUG	Artemether-lumefantrine combination	20/120mg Artemether-lumefantrine 4-35 months: 1 tablet twice daily for 3 days; 36-59 months: 2 tablets twice daily for 3 days
DRUG	amoxycillin	amoxycillin 250mg tab 4-12 months: 1/2x2; 13-35 months: 1x2; 36-59 months: 11/2x2
DRUG	paracetamol	paracetamol 500mg tablet \<36months: 1/4x4 for 2 days; 36-59months: 1/2x4 for 2 days
DEVICE	malaria rapid diagnostic test, respiratory rate timer	malaria dipstick, and breath timer
DRUG	Artemether-lumefantrine combination	20/120mg tablet arthermether-lumefantrine 4-35months: 1x2; 36-59months: 2x2

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2008-07-23
• Last updated: 2012-03-16

Locations

4 sites across 3 countries: Burkina Faso, Ghana, Uganda