Clinical trial NCT00720811: Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs
Official title: Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Pneumonia
Keywords: Malaria ACT
Rapid
Diagnosis
Community
health
worker
Artemesinin
based
Combination
Therapy
Anti Malarial
Treatment
antibiotics
Lead sponsor: Mbarara University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Makerere University
name: Ministry of Health, Uganda
name: Navrongo Health Research Centre, Ghana
name: National Malaria Research and Training Centre, Burkina Faso
First posted: 2008-07-23
Enrollment: 6456
Sex: ALL
Minimum age (years): 4
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Recovery rate from fever at Day 3
timeFrame: Day 3
Secondary outcomes:
measure: use of antimalarial and antibiotic drugs by community health workers
timeFrame: After patient enrollment
measure: Recovery rate from fever at Day 7
timeFrame: Day 7
Other outcomes:
Locations:
city: Sapone
country: Burkina Faso
facility: Sapone Site
city: Kassana
country: Ghana
facility: Kassena Nankana Site
city: Iganga
country: Uganda
facility: Iganga Site
city: Mbarara
country: Uganda
facility: Mbarara Site
Study officials:
affiliation: Mbarara University of Science and Technology
name: Francis Bajunirwe, MBChB PhD
role: STUDY_DIRECTOR
affiliation: Makerere University
name: George Pariyo, MB ChB, PhD
role: STUDY_DIRECTOR
affiliation: Malaria Consortium
name: James Tibenderana, MB ChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Malaria Research and Training Center, Burkina Faso
name: Alfred Tiono, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Navrongo Health Research Centre, Ghana
name: Thomas Anyorigiya, MSc
role: PRINCIPAL_INVESTIGATOR
References: