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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mbarara University of Science and Technology
• Collaborators: Makerere University; Ministry of Health, Uganda; National Malaria Research and Training Centre, Burkina Faso; Navrongo Health Research Centre, Ghana
• Treatments: Acetaminophen; Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Lumefantrine

Criteria

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