The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level

Study Overview
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Brief Summary
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This study aims to test directly by means of a cluster randomized controlled trial, the impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers, the main non-formal outlet for drugs locally, at community level.

Detailed Description
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In many settings the majority of people with malaria particularly the poorest do not access formal care but access anti-malarials at the informal community level. ACTs were previously unaffordable to this group but this should change with the introduction of the AMFm. To avoid missing alternative causes of illness, reduce costs and delay the spread of resistance to ACTs, they need to be targeted at those who really need them. Studies in formal healthcare settings in Ghana have shown that where microscopy is not available, the impact of Rapid Diagnostic Tests (RDTs) can be substantial. RDTs are relatively simple to use, requiring fairly minimal training to master the mechanics of test preparation and interpretation Whether to deploy RDTs as part of AMFm is unclear at this time.Even in the absence of AMFm the question about how best to target antimalarials in the community is an important one, and will get more so as malaria incidence in many countries decreases, making presumptive treatment of all febrile illness as malaria increasingly ineffective. Locally chemical sellers are the closest equivalent as they provide the majority of treatments, especially for the poorest. It is difficult to predict whether RDTs would make chemical sellers more commonly accessed (because patients prefer a diagnosis) , or less accessed (patients do not like having choice restricted/do not want a blood test etc). Studies in other settings suggest interventions to improve diagnosis by shop-keepers can be effective and cost-effective .

Official Title
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The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level: a Cluster Randomized Trial

Conditions
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Malaria

Intervention / Treatment
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* Procedure: Rapid Diagnostic Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients reporting to chemical seller with complaint of fever or who request for an anti-malarial drug Exclusion Criteria: Clients providing a prescription from a health facility Clients with signs of severe disease who will be referred onward

Ages Eligible for Study
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Minimum Age: 6 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid Diagnostic Test<br>Rapid Diagnostic Test for malaria to direct antimalarial dispensing decisions in Chemical Shops | Procedure: Rapid Diagnostic Test<br>* Rapid Diagnostic Test for Malaria carried out to direct antimalarial dispensing. No antimalarials for negative tests, antimalarials for positive tests<br>* Other names: RDT;|
| No Intervention: No RDT<br>Chemical sellers dispense antimalarials as per their own decisions without the benefit of test results | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms | Out of all clients who test negative when their blood slides are read by two independent expert microscopists, how many received an antimalarial treatment from the Licensed Chemical Seller | Until the estimated sample size is obtained or up to 2 yrs whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm | Out of all clients who test negative by RDT, number who receive an antimalarial | Until the estimated sample size is obtained or up to 2 years, whichever comes first | 
| Proportion of clients tested using a Rapid Diagnostic Test | The number of clients who agree to be tested with an RDT Out of all clients who meet inclusion criteria | Until the estimated sample size is obtained or up to 2 years, whichever comes first | 
| Proportion of clients in each arm receiving an antibiotic | The number of clients in the intervention and control arms who receive an antibiotic out of the total number of clients recruited into each arm | Until the estimated sample size is obtained or up to 2 years, whichever comes first | 
| Proportion of clients receiving addittional or alternative treatments to antimalarial and which these are | The number of clients who receive additional or alternative treatments in the intervention and control arms out of the total number recruited into both arms | Until the estimated sample size is obtained or up to 2 years, whichever comes first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria, Rapid Diagnostic Tests for Malaria, Chemical Shops, Drug Shops, Diagnostics, Testing for Malaria