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

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.

Study Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Behavioral: RDT Training and Subsidy Offered; Behavioral: Information/Education Campaign

• Study Type: Interventional
• Enrollment (Actual): 2800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Clinton Health Access Initiative
  • Kampala, Uganda
    • Innovations for Poverty Action-Uganda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Up To One Year

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: Clinton Health Access Initiative, Nigeria; Uganda Health Marketing Group; Innovations for Poverty Action-Uganda
• Investigators: 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 record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 27, 2012
• First Posted (Estimate): July 30, 2012

Study Record Updates

• Last Update Posted (Estimate): July 30, 2012
• Last Update Submitted That Met QC Criteria: July 27, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: RDTs; Rapid Diagnostic Tests; Drug Shops; Malaria Diagnosis; Private Sector; Retail Sector
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: 19371-106; HS805 (Other Identifier: Uganda National Council for Science and Technology)