Feasibility and Impact of Malaria Rapid Diagnostic Tests in the African Retail Sector

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652365
• Other study ID #: 19371-106
• Secondary ID: HS805
• Status: Completed
• Phase: N/A
• First received: July 24, 2012
• Last updated: July 27, 2012
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Harvard School of Public Health Office of Regulatory Affairs and Research ComplianceUganda: Uganda National Council for Science and Technology
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2800
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malaria

Intervention

Behavioral:
• RDT Training and Subsidy Offered

• Information/Education Campaign

Locations

Country	Name	City	State
Uganda	Clinton Health Access Initiative	Kampala
Uganda	Innovations for Poverty Action-Uganda	Kampala

Sponsors (4)

Lead Sponsor	Collaborator
Harvard School of Public Health	Clinton Health Access Initiative, Nigeria, Innovations for Poverty Action-Uganda, Uganda Health Marketing Group

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean RDT Price Charged by Shops		Up to One Year	No
Secondary	Mean RDTs Purchased by Shops from Wholesaler		Up To One Year	No
Secondary	Fraction of Monitoring Checklist Items Performed Correctly by Shops		Up To One Year	No
Secondary	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	No

External Links

•   G Fink (PI) website
•   J Cohen (PI) website
•   Project Description