Introducing Rapid Diagnostic Tests Into the Private Health Sector

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, artemisinin combination therapies (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 ocal drug shops in an area with high malaria transmission.

Official Title
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Introducing Rapid Diagnostic Tests Into the Private Health Sector in Uganda: a Randomised Trial Among Registered Drug Shops to Evaluate Impact on Antimalarial Drug Use

Conditions
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Fever, Malaria, Diagnosis, Referral

Intervention / Treatment
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* Device: Rapid diagnostic test
* Drug: Lumartem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with fever uncomplicted malaria Exclusion Criteria: Complicated malaria known allergic reactions to Lumartem

Ages Eligible for Study
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Minimum Age: 1 Month

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rapid diagnostic test<br>Treatment and diagnosis of malaria in drugs hops using rapid diagnostic tests | Device: Rapid diagnostic test<br>* Diagnosis of malaria using rapid diagnostic test<br>Drug: Lumartem<br>* Presumptive treatment of malaria/fever<br>|
| No Intervention: Presumptive malaria treatment<br>Presumptive treatment for malaria in drug shops | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriateness of treatment |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriateness of referral of complicated malaria cases |  | 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, appropriate treatment, appropriate referral