NCT Number: NCT01652365
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Clinton Health Access Initiative, Kampala, Uganda
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Information/Education Campaign
BehavioralPrimary outcomes
-
Fraction of Illnesses Diagnosed for Malaria
Time frame: Up To One Year
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.
Secondary outcomes
-
Mean RDT Price Charged by Shops
Time frame: Up to One Year
-
Mean RDTs Purchased by Shops from Wholesaler
Time frame: Up To One Year
-
Fraction of Monitoring Checklist Items Performed Correctly by Shops
Time frame: Up To One Year
-
Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is Taken
Time frame: Up To One Year
- 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
Sponsors and collaborators
Lead sponsor
Harvard School of Public Health (HSPH)
Other
Collaborators
- Clinton Health Access Initiative, Nigeria
- Innovations for Poverty Action-Uganda
- Uganda Health Marketing Group
Registry information
Official study title
Evaluation of the Feasibility and Impact of Introducing Malaria Rapid Diagnostic Tests in the Retail Sector: A Randomized Controlled Trial in Eastern Uganda
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Jul 30, 2012
- Registry last updated
- Jul 30, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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