Skip to main content
OpenTrials
Completed

NCT Number: NCT01652365

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinton Health Access Initiative, Kampala, Uganda

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RDT Training and Subsidy Offered

Behavioral

Information/Education Campaign

Behavioral

Primary outcomes

  1. Fraction of Illnesses Diagnosed for Malaria

    Time frame: Up To One Year

    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.

Secondary outcomes

  1. Mean RDT Price Charged by Shops

    Time frame: Up to One Year

  2. Mean RDTs Purchased by Shops from Wholesaler

    Time frame: Up To One Year

  3. Fraction of Monitoring Checklist Items Performed Correctly by Shops

    Time frame: Up To One Year

  4. Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is Taken

    Time frame: Up 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

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Clinton Health Access Initiative, Nigeria
  • Innovations for Poverty Action-Uganda
  • Uganda Health Marketing Group

Registry information

Official study title

Evaluation of the Feasibility and Impact of Introducing Malaria Rapid Diagnostic Tests in the Retail Sector: A Randomized Controlled Trial in Eastern Uganda

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 30, 2012
Registry last updated
Jul 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.