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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01652365
Enrollment
2800
Registered
2012-07-30
Start date
2011-03-31
Completion date
2012-06-30
Last updated
2012-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

Malaria Diagnosis, Rapid Diagnostic Tests, RDTs, Private Sector, Retail Sector, Drug Shops

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.

Interventions

BEHAVIORALRDT Training and Subsidy Offered
BEHAVIORALInformation/Education Campaign

Sponsors

Clinton Health Access Initiative, Nigeria
CollaboratorOTHER
Innovations for Poverty Action-Uganda
CollaboratorUNKNOWN
Uganda Health Marketing Group
CollaboratorUNKNOWN
Harvard School of Public Health (HSPH)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fraction of Illnesses Diagnosed for MalariaUp To One YearComparison 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

MeasureTime frameDescription
Mean RDT Price Charged by ShopsUp to One Year
Mean RDTs Purchased by Shops from WholesalerUp To One Year
Fraction of Monitoring Checklist Items Performed Correctly by ShopsUp To One Year
Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is TakenUp 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

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026