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

July 22, 2013 updated by: Evelyn K. Ansah, Ghana Health Services

The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level: a Cluster Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

4748

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
    • Greater Accra
      • Dodowa, Greater Accra, Ghana, Box DD1
        • Dodowa Health Research Centre, Ghana Health Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until the estimated sample size is obtained or up to 2 yrs whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until the estimated sample size is obtained or up to 2 years, whichever comes first
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
Until the estimated sample size is obtained or up to 2 years, whichever comes first
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
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
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
Until the estimated sample size is obtained or up to 2 years, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ghana Health Services

Collaborators

London School of Hygiene and Tropical Medicine

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

September 2, 2012

First Submitted That Met QC Criteria

July 22, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

July 25, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITDCVT68
  • MCDC_SF_02 (Other Grant/Funding Number: Malaria Capacity Development Consortium (MCDC))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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