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The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level (GhanaCommRDT)

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ClinicalTrials.gov Identifier: NCT01907672
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Evelyn K. Ansah, Ghana Health Services

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.

Condition or disease Intervention/treatment Phase
Malaria Procedure: Rapid Diagnostic Test Phase 4

Detailed Description:

In many settings the majority of people with malaria particularly the poorest do not access formal care but access anti-malarials at the informal community level. ACTs were previously unaffordable to this group but this should change with the introduction of the AMFm. To avoid missing alternative causes of illness, reduce costs and delay the spread of resistance to ACTs, they need to be targeted at those who really need them. Studies in formal healthcare settings in Ghana have shown that where microscopy is not available, the impact of Rapid Diagnostic Tests (RDTs) can be substantial. RDTs are relatively simple to use, requiring fairly minimal training to master the mechanics of test preparation and interpretation Whether to deploy RDTs as part of AMFm is unclear at this time.Even in the absence of AMFm the question about how best to target antimalarials in the community is an important one, and will get more so as malaria incidence in many countries decreases, making presumptive treatment of all febrile illness as malaria increasingly ineffective. Locally chemical sellers are the closest equivalent as they provide the majority of treatments, especially for the poorest.

It is difficult to predict whether RDTs would make chemical sellers more commonly accessed (because patients prefer a diagnosis) , or less accessed (patients do not like having choice restricted/do not want a blood test etc). Studies in other settings suggest interventions to improve diagnosis by shop-keepers can be effective and cost-effective .


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4748 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level: a Cluster Randomized Trial
Study Start Date : August 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Rapid Diagnostic Test
Rapid Diagnostic Test for malaria to direct antimalarial dispensing decisions in Chemical Shops
Procedure: Rapid Diagnostic Test
Rapid Diagnostic Test for Malaria carried out to direct antimalarial dispensing. No antimalarials for negative tests, antimalarials for positive tests
Other Names:
  • mRDT
  • RDT for malaria
  • RDT

No Intervention: No RDT
Chemical sellers dispense antimalarials as per their own decisions without the benefit of test results



Primary Outcome Measures :
  1. The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms [ Time Frame: Until the estimated sample size is obtained or up to 2 yrs whichever comes first ]
    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


Secondary Outcome Measures :
  1. Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm [ Time Frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first ]
    Out of all clients who test negative by RDT, number who receive an antimalarial

  2. Proportion of clients tested using a Rapid Diagnostic Test [ Time Frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first ]
    The number of clients who agree to be tested with an RDT Out of all clients who meet inclusion criteria

  3. Proportion of clients in each arm receiving an antibiotic [ Time Frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first ]
    The number of clients in the intervention and control arms who receive an antibiotic out of the total number of clients recruited into each arm

  4. Proportion of clients receiving addittional or alternative treatments to antimalarial and which these are [ Time Frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first ]
    The number of clients who receive additional or alternative treatments in the intervention and control arms out of the total number recruited into both arms



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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients reporting to chemical seller with complaint of fever or who request for an anti-malarial drug

Exclusion Criteria:

  • Clients providing a prescription from a health facility
  • Clients with signs of severe disease who will be referred onward

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907672


Locations
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Ghana
Dodowa Health Research Centre, Ghana Health Service
Dodowa, Greater Accra, Ghana, Box DD1
Sponsors and Collaborators
Ghana Health Services
London School of Hygiene and Tropical Medicine
Investigators
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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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Evelyn K. Ansah, Deputy Director (Research), Ghana Health Services
ClinicalTrials.gov Identifier: NCT01907672     History of Changes
Other Study ID Numbers: ITDCVT68
MCDC_SF_02 ( Other Grant/Funding Number: Malaria Capacity Development Consortium (MCDC) )
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013

Keywords provided by Evelyn K. Ansah, Ghana Health Services:
Malaria
Rapid Diagnostic Tests for Malaria
Chemical Shops
Drug Shops
Diagnostics
Testing for Malaria

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents