Feasibility and Impact of Malaria Rapid Diagnostic Tests in the African Retail Sector
Evaluation of the Feasibility and Impact of Introducing Malaria Rapid Diagnostic Tests in the Retail Sector: A Randomized Controlled Trial in Eastern Uganda
2 other identifiers
interventional
2,800
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 24, 2012
CompletedFirst Posted
Study publicly available on registry
July 30, 2012
CompletedJuly 30, 2012
July 1, 2012
1.3 years
July 24, 2012
July 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Up To One Year
Study Arms (4)
RDT Training and Subsidy Offered
EXPERIMENTALLicensed 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.
Information/Education Campaign
EXPERIMENTALCommunity 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.
RDT Training/Subsidy + Information/Education Campaign
EXPERIMENTALIncludes both the training and subsidy component and the information/education campaign component.
Control
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Drug Shops:
- Drug Shop not registered with Ugandan National Drug Authority
- Female household head is under 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard School of Public Health (HSPH)lead
- Clinton Health Access Initiative, Nigeriacollaborator
- Innovations for Poverty Action-Ugandacollaborator
- Uganda Health Marketing Groupcollaborator
Study Sites (2)
Clinton Health Access Initiative
Kampala, Uganda
Innovations for Poverty Action-Uganda
Kampala, Uganda
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica Cohen, PhD
Harvard School of Public Health (HSPH)
- PRINCIPAL INVESTIGATOR
Gunther Fink, PhD
Harvard School of Public Health (HSPH)
- PRINCIPAL INVESTIGATOR
William Dickens, PhD
Northeastern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 24, 2012
First Posted
July 30, 2012
Study Start
March 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
July 30, 2012
Record last verified: 2012-07