The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level
GhanaCommRDT
2 other identifiers
interventional
4,748
1 country
1
Brief Summary
This study aims to test directly by means of a cluster randomized controlled trial, the impact of the introduction of RDTs for malaria on dispensing behaviour of chemical sellers, the main non-formal outlet for drugs locally, at community level.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 25, 2013
CompletedJuly 25, 2013
July 1, 2013
1.3 years
September 2, 2012
July 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms
Out of all clients who test negative when their blood slides are read by two independent expert microscopists, how many received an antimalarial treatment from the Licensed Chemical Seller
Until the estimated sample size is obtained or up to 2 yrs whichever comes first
Secondary Outcomes (4)
Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm
Until the estimated sample size is obtained or up to 2 years, whichever comes first
Proportion of clients tested using a Rapid Diagnostic Test
Until the estimated sample size is obtained or up to 2 years, whichever comes first
Proportion of clients in each arm receiving an antibiotic
Until the estimated sample size is obtained or up to 2 years, whichever comes first
Proportion of clients receiving addittional or alternative treatments to antimalarial and which these are
Until the estimated sample size is obtained or up to 2 years, whichever comes first
Study Arms (2)
Rapid Diagnostic Test
EXPERIMENTALRapid Diagnostic Test for malaria to direct antimalarial dispensing decisions in Chemical Shops
No RDT
NO INTERVENTIONChemical sellers dispense antimalarials as per their own decisions without the benefit of test results
Interventions
Rapid Diagnostic Test for Malaria carried out to direct antimalarial dispensing. No antimalarials for negative tests, antimalarials for positive tests
Eligibility Criteria
You may qualify if:
- Patients reporting to chemical seller with complaint of fever or who request for an anti-malarial drug
You may not qualify if:
- Clients providing a prescription from a health facility
- Clients with signs of severe disease who will be referred onward
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dodowa Health Research Centre, Ghana Health Service
Dodowa, Greater Accra Region, Box DD1, Ghana
Related Publications (1)
Ansah EK, Narh-Bana S, Affran-Bonful H, Bart-Plange C, Cundill B, Gyapong M, Whitty CJ. The impact of providing rapid diagnostic malaria tests on fever management in the private retail sector in Ghana: a cluster randomized trial. BMJ. 2015 Mar 4;350:h1019. doi: 10.1136/bmj.h1019.
PMID: 25739769DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evelyn K Ansah, MD,MPH,PhD
Ghana Health Services
- PRINCIPAL INVESTIGATOR
Christopher C Whitty, BSc,MSc,PhD
London School of Hygiene and Tropical Medicine
- PRINCIPAL INVESTIGATOR
Margaret Gyapong, BSc,MSc,PhD
Ghana Health Services
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director (Research)
Study Record Dates
First Submitted
September 2, 2012
First Posted
July 25, 2013
Study Start
August 1, 2011
Primary Completion
December 1, 2012
Study Completion
April 1, 2013
Last Updated
July 25, 2013
Record last verified: 2013-07