Clinical trial NCT01652365: Feasibility and Impact of Malaria Rapid Diagnostic Tests in the African Retail Sector
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: Malaria Diagnosis
Rapid Diagnostic Tests
RDTs
Private Sector
Retail Sector
Drug Shops
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Clinton Health Access Initiative, Nigeria
name: Innovations for Poverty Action-Uganda
name: Uganda Health Marketing Group
First posted: 2012-07-30
Enrollment: 2800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fraction of Illnesses Diagnosed for Malaria
timeFrame: Up To One Year
Secondary outcomes:
measure: Mean RDT Price Charged by Shops
timeFrame: Up to One Year
measure: Mean RDTs Purchased by Shops from Wholesaler
timeFrame: Up To One Year
measure: Fraction of Monitoring Checklist Items Performed Correctly by Shops
timeFrame: Up To One Year
measure: Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is Taken
timeFrame: Up To One Year
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Clinton Health Access Initiative
city: Kampala
country: Uganda
facility: Innovations for Poverty Action-Uganda
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Jessica Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Gunther Fink, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeastern University
name: William Dickens, PhD
role: PRINCIPAL_INVESTIGATOR
References: