Feasibility and Impact of Malaria Rapid Diagnostic Tests in the African Retail Sector
This study has been completed.
Sponsor:
Harvard School of Public Health
Collaborators:
Clinton Health Access Initiative
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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
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 May 22, 2013