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

President and Fellows of Harvard College

Status: Completed

Conditions: Malaria

Treatments: Behavioral: RDT Training and Subsidy Offered; Behavioral: Information/Education Campaign

Study type: Interventional

Funder types: Other

Identifiers

NCT01652365

19371-106

HS805 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,800 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

2,800 participants in 4 patient groups

RDT Training and Subsidy Offered

Experimental group

Description:

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.

Treatment:

Behavioral: RDT Training and Subsidy Offered

Information/Education Campaign

Experimental group

Description:

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.

Treatment:

Behavioral: Information/Education Campaign

RDT Training/Subsidy + Information/Education Campaign

Experimental group

Description:

Includes both the training and subsidy component and the information/education campaign component.

Treatment:

Behavioral: RDT Training and Subsidy Offered

Behavioral: Information/Education Campaign

Control

No Intervention group