Feasibility and Impact of Malaria Rapid Diagnostic Tests in the African Retail Sector
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.
Behavioral: RDT Training and Subsidy Offered
Behavioral: Information/Education Campaign
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Evaluation of the Feasibility and Impact of Introducing Malaria Rapid Diagnostic Tests in the Retail Sector: A Randomized Controlled Trial in Eastern Uganda|
- Fraction of Illnesses Diagnosed for Malaria [ Time Frame: Up To One Year ] [ Designated as safety issue: No ]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.
- Mean RDT Price Charged by Shops [ Time Frame: Up to One Year ] [ Designated as safety issue: No ]
- Mean RDTs Purchased by Shops from Wholesaler [ Time Frame: Up To One Year ] [ Designated as safety issue: No ]
- Fraction of Monitoring Checklist Items Performed Correctly by Shops [ Time Frame: Up To One Year ] [ Designated as safety issue: No ]
- Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is Taken [ Time Frame: Up To One Year ] [ Designated as safety issue: No ]
- 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
|Study Start Date:||March 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: RDT Training and Subsidy Offered
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|
Experimental: Information/Education Campaign
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|
Experimental: RDT Training/Subsidy + Information/Education Campaign
Includes both the training and subsidy component and the information/education campaign component.
|Behavioral: RDT Training and Subsidy Offered Behavioral: Information/Education Campaign|
|No Intervention: Control|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652365
|Clinton Health Access Initiative|
|Innovations for Poverty Action-Uganda|
|Principal Investigator:||Jessica Cohen, PhD||Harvard School of Public Health|
|Principal Investigator:||Gunther Fink, PhD||Harvard School of Public Health|
|Principal Investigator:||William Dickens, PhD||Northeastern University|