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

This study has been completed.
Sponsor:
Collaborators:
Clinton Health Access Initiative, Nigeria
Innovations for Poverty Action-Uganda
Uganda Health Marketing Group
Information provided by (Responsible Party):
Jessica Cohen, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01652365
First received: July 24, 2012
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Malaria
Behavioral: RDT Training and Subsidy Offered
Behavioral: Information/Education Campaign

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Fraction of Illnesses Diagnosed for Malaria [ Time Frame: Up To One Year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Mean RDT Price Charged by Shops [ Time Frame: Up to One Year ] [ Designated as safety issue: No ]
  • Mean RDTs Purchased by Shops from Wholesaler [ Time Frame: Up To One Year ] [ Designated as safety issue: No ]
  • Fraction of Monitoring Checklist Items Performed Correctly by Shops [ Time Frame: Up To One Year ] [ Designated as safety issue: No ]
  • Fraction of Illnesses for which an Antimalarial/ACT/Antibiotic is Taken [ Time Frame: Up To One Year ] [ Designated as safety issue: No ]
    • 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


Enrollment: 2800
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652365

Locations
Uganda
Innovations for Poverty Action-Uganda
Kampala, Uganda
Clinton Health Access Initiative
Kampala, Uganda
Sponsors and Collaborators
Harvard School of Public Health
Clinton Health Access Initiative, Nigeria
Innovations for Poverty Action-Uganda
Uganda Health Marketing Group
Investigators
Principal Investigator: Jessica Cohen, PhD Harvard School of Public Health
Principal Investigator: Gunther Fink, PhD Harvard School of Public Health
Principal Investigator: William Dickens, PhD Northeastern University
  More Information

Additional Information:
No publications provided

Responsible Party: Jessica Cohen, Assistant Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01652365     History of Changes
Other Study ID Numbers: 19371-106, HS805
Study First Received: July 24, 2012
Last Updated: July 27, 2012
Health Authority: United States: Harvard School of Public Health Office of Regulatory Affairs and Research Compliance
Uganda: Uganda National Council for Science and Technology

Keywords provided by Harvard School of Public Health:
Malaria Diagnosis
Rapid Diagnostic Tests
RDTs
Private Sector
Retail Sector
Drug Shops

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 24, 2014