Abstract
BackgroundThere is mounting evidence of poor adherence by health service personnel to clinical guidelines for malaria following a symptomatic diagnosis. In response to this, the World Health Organization (WHO) recommends that in all settings clinical suspicion of malaria should be confirmed by parasitological diagnosis using microscopy or Rapid Diagnostic Test (RDT). The Government of Nigeria plans to introduce RDTs in public health facilities over the coming year. In this context, we will evaluate the effectiveness and cost-effectiveness of two interventions designed to support the roll-out of RDTs and improve the rational use of ACTs. It is feared that without supporting interventions, non-adherence will remain a serious impediment to implementing malaria treatment guidelines.Methods/designA three-arm stratified cluster randomized trial is used to compare the effectiveness and cost-effectiveness of: (1) provider malaria training intervention versus expected standard practice in malaria diagnosis and treatment; (2) provider malaria training intervention plus school-based intervention versus expected standard practice; and (3) the combined provider plus school-based intervention versus provider intervention alone. RDTs will be introduced in all arms of the trial. The primary outcome is the proportion of patients attending facilities that report a fever or suspected malaria and receive treatment according to malaria guidelines. This will be measured by surveying patients (or caregivers) as they exit primary health centers, pharmacies, and patent medicine dealers. Cost-effectiveness will be presented in terms of the primary outcome and a range of secondary outcomes, including changes in provider and community knowledge. Costs will be estimated from both a societal and provider perspective using standard economic evaluation methodologies.Trial registrationClinicaltrials.gov NCT01350752
Highlights
There is mounting evidence of poor adherence by health service personnel to clinical guidelines for malaria following a symptomatic diagnosis
In addition to securing cost savings, it is argued that parasitological diagnosis: improves patient care in parasitepositive patients owing to greater certainty that the patient has malaria; helps to identify parasite-negative patients in whom another diagnosis must be sought; prevents unnecessary exposure to antimalarials, thereby reducing side-effects, drug interactions, and selection pressure; improves health information; and confirms treatment failures [7]
Since the school-based intervention is being delivered at the community level a cluster is defined as a geographical community which contains at least one facility and one school, and this will be the unit of randomization with study site as the stratum
Summary
There is mounting evidence of poor adherence by health service personnel to clinical guidelines for malaria following a symptomatic diagnosis. Combined with the fact that clinical diagnosis may result in over-diagnosis because the signs and symptoms of malaria are non-specific and overlap with other febrile diseases [6], ‘the relatively high cost of ACTs makes waste through unnecessary treatment of patients without parasitaemia unsustainable’ [7]. This has led to growing pressure to improve the specificity of malaria diagnosis. Malaria test completed by providers (from register of malaria tests at facility)
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