Feasibility and Impact of Malaria Rapid Diagnostic Tests in the African Retail Sector

Study Overview
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Brief Summary
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The purpose of this study is to assess the feasibility and impact of introducing subsidized malaria rapid diagnostic tests (RDTs) into retail sector drug shops in Uganda. This is a randomized controlled trial at the village level, taking place in 6 districts in Eastern Uganda. Licensed drug shops in selected villages were trained in proper RDT storage, administration, interpretation and disposal and were given access to subsidized RDTs for sale. This study explores whether drug shop owners--when given access to training and subsidized RDTs--will choose to promote and sell RDTs to customers and, if so, at what volume and what price. The investigators also explore whether shops will safely store, administer, interpret and dispose of RDTs and to what extent they will use RDT results to guide treatment recommendations. Finally, the study explores whether making RDTs available for sale in local drug shops has a community level impact on diagnostic testing and appropriate treatment for malaria.

Official Title
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Evaluation of the Feasibility and Impact of Introducing Malaria Rapid Diagnostic Tests in the Retail Sector: A Randomized Controlled Trial in Eastern Uganda

Conditions
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Malaria

Intervention / Treatment
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* Behavioral: RDT Training and Subsidy Offered
* Behavioral: Information/Education Campaign


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Drug Shops: Licensed and registered as a Drug Shop with the Ugandan National Drug Authority Households: Live in the village of participating drug shop Female household head is 18 or over Exclusion Criteria: Drug Shops: Drug Shop not registered with Ugandan National Drug Authority Female household head is under 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RDT Training and Subsidy Offered<br>Licensed drug shops within villages selected randomly to be in this arm will be invited to training on RDTs and offered access to subsidized RDTs available for purchase at a local wholesale pharmacy in Mbale, Uganda. | Behavioral: RDT Training and Subsidy Offered<br> <br> |
| Experimental: Information/Education Campaign<br>Community meetings describing RDTs and encouraging community members to be diagnosed prior to taking malaria treatment will be held in villages randomly assigned to this treatment arm. | Behavioral: Information/Education Campaign<br> <br> |
| Experimental: RDT Training/Subsidy + Information/Education Campaign<br>Includes both the training and subsidy component and the information/education campaign component. | Behavioral: RDT Training and Subsidy Offered<br> <br> Behavioral: Information/Education Campaign<br> <br> |
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of Illnesses Diagnosed for Malaria | Comparison of the rate of malaria diagnosis in treatment vs. control. Comparison will be at the village level and at the shop level. Denominator will be: all illnesses, febrile illnesses only or suspected malaria episodes only. | Up To One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean RDT Price Charged by Shops |  | Up to One Year | 
| Mean RDTs Purchased by Shops from Wholesaler |  | Up To One Year | 
| Fraction of Monitoring Checklist Items Performed Correctly by Shops |  | Up To One Year | 
| Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is Taken | Comparison of rate of antimalarial taking for illnesses in treatment vs. control Comparison of rate of ACT taking for illnesses in treatment vs. control Comparison of rate of antibiotic taking for illnesses in treatment vs. control | Up To One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria Diagnosis, Rapid Diagnostic Tests, RDTs, Private Sector, Retail Sector, Drug Shops