Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria

Study Overview
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Brief Summary
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Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and impact, ACTs should be deployed in HMM programmes, as well as in formal health facilities. Up to 80% of malaria cases are treated outside the formal health sector and shops are frequently visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role of shops in home management and to ensure that drugs sold are appropriate. The current practice of presumptive treatment of any febrile illness as malaria (both at health facilities and in the context of HMM) based solely on clinical symptoms without routine laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT being a more costly regimen, it is important to be more restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in remote locations lacking electricity and qualified health staff. This study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by community-based drug distributors.The accuracy of RDTs, and the acceptability of this approach, will be evaluated in both low and high transmission areas.

Official Title
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Role and Effectiveness of Rapid Diagnostic Tests in Home-based Management of Malaria: Comparative Trials in Two Areas of High and Low Transmission in Uganda

Conditions
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Fever, Malaria

Intervention / Treatment
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* Device: Rapid diagnostic test
* Other: presumptive malaria treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged between 6 months and 5 years (< 5 years)reported with fever by the mother/ caretaker of the child Children with uncomplicated malaria/ fever episodes Children whose mothers consent to participate Exclusion Criteria: Children aged less 6 months or greater than 4 years (≥ 5 years) Children requiring referral to a health facility (severe malaria, complicated fever episode, convulsions/fits, loss of consciousness, and other danger signs) Children whose mothers refuse to consent

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rapid diagnostic test and treatment<br> | Device: Rapid diagnostic test<br>* Use of rapid daignostic tests for diagnosis of malaria<br>|
| Other: Treatment without rapid daignostic test<br> | Other: presumptive malaria treatment<br>* Treatment of malariabased on clinical diagnosis without use of diagnostic test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients given prompt effective treatment by CDDs: % of <5-year-old children diagnosed with malaria who receive appropriate ACT treatment within 24 hours of onset of malaria. |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coverage of prompt effective treatment: % of <5-year-old children with fever who received ACT treatment within 24 hours of onset of malaria, measured through household surveys. |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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History of fever, measured fever