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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 4
Locations
Ghana
Study Type
Interventional
Intervention
Rapid Diagnostic Test
Sponsored by
Ghana Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malaria focused on measuring Malaria, Rapid Diagnostic Tests for Malaria, Chemical Shops, Drug Shops, Diagnostics, Testing for Malaria

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dodowa Health Research Centre, Ghana Health Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rapid Diagnostic Test

No RDT

Arm Description

Rapid Diagnostic Test for malaria to direct antimalarial dispensing decisions in Chemical Shops

Chemical sellers dispense antimalarials as per their own decisions without the benefit of test results

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm
Out of all clients who test negative by RDT, number who receive an antimalarial
Proportion of clients tested using a Rapid Diagnostic Test
The number of clients who agree to be tested with an RDT Out of all clients who meet inclusion criteria
Proportion of clients in each arm receiving an antibiotic
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
Proportion of clients receiving addittional or alternative treatments to antimalarial and which these are
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

Full Information

First Posted
September 2, 2012
Last Updated
July 22, 2013
Sponsor
Ghana Health Services
Collaborators
London School of Hygiene and Tropical Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01907672
Brief Title
The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level
Acronym
GhanaCommRDT
Official Title
The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level: a Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ghana Health Services
Collaborators
London School of Hygiene and Tropical Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria, Rapid Diagnostic Tests for Malaria, Chemical Shops, Drug Shops, Diagnostics, Testing for Malaria

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4748 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid Diagnostic Test
Arm Type
Experimental
Arm Description
Rapid Diagnostic Test for malaria to direct antimalarial dispensing decisions in Chemical Shops
Arm Title
No RDT
Arm Type
No Intervention
Arm Description
Chemical sellers dispense antimalarials as per their own decisions without the benefit of test results
Intervention Type
Procedure
Intervention Name(s)
Rapid Diagnostic Test
Other Intervention Name(s)
mRDT, RDT for malaria, RDT
Intervention Description
Rapid Diagnostic Test for Malaria carried out to direct antimalarial dispensing. No antimalarials for negative tests, antimalarials for positive tests
Primary Outcome Measure Information:
Title
The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms
Description
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
Time Frame
Until the estimated sample size is obtained or up to 2 yrs whichever comes first
Secondary Outcome Measure Information:
Title
Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm
Description
Out of all clients who test negative by RDT, number who receive an antimalarial
Time Frame
Until the estimated sample size is obtained or up to 2 years, whichever comes first
Title
Proportion of clients tested using a Rapid Diagnostic Test
Description
The number of clients who agree to be tested with an RDT Out of all clients who meet inclusion criteria
Time Frame
Until the estimated sample size is obtained or up to 2 years, whichever comes first
Title
Proportion of clients in each arm receiving an antibiotic
Description
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
Time Frame
Until the estimated sample size is obtained or up to 2 years, whichever comes first
Title
Proportion of clients receiving addittional or alternative treatments to antimalarial and which these are
Description
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
Time Frame
Until the estimated sample size is obtained or up to 2 years, whichever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelyn K Ansah, MD,MPH,PhD
Organizational Affiliation
Ghana Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher C Whitty, BSc,MSc,PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret Gyapong, BSc,MSc,PhD
Organizational Affiliation
Ghana Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dodowa Health Research Centre, Ghana Health Service
City
Dodowa
State/Province
Greater Accra
ZIP/Postal Code
Box DD1
Country
Ghana

12. IPD Sharing Statement

Citations:
PubMed Identifier
25739769
Citation
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.
Results Reference
derived
Links:
URL
http://www.mcdconsortium.org
Description
Malaria Capacity Development Consortium

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

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