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

NCT ID: NCT01907672

Last Updated: 2013-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 4748 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-04-30

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 .

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Rapid Diagnostic Test

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

Group Type: EXPERIMENTAL

Rapid Diagnostic Test

Intervention Type: PROCEDURE

Rapid Diagnostic Test for Malaria carried out to direct antimalarial dispensing. No antimalarials for negative tests, antimalarials for positive tests

No RDT

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rapid Diagnostic Test

Rapid Diagnostic Test for Malaria carried out to direct antimalarial dispensing. No antimalarials for negative tests, antimalarials for positive tests

Intervention Type: PROCEDURE

Other Intervention Names

mRDT; RDT for malaria; RDT

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

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

Ghana Health Services

OTHER_GOV

Sponsor Role: lead

Responsible Party

Evelyn K. Ansah

Deputy Director (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evelyn K Ansah, MD,MPH,PhD

Role: PRINCIPAL_INVESTIGATOR

Ghana Health Services

Christopher C Whitty, BSc,MSc,PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Margaret Gyapong, BSc,MSc,PhD

Role: PRINCIPAL_INVESTIGATOR

Ghana Health Services

Locations

Dodowa Health Research Centre, Ghana Health Service

Dodowa, Greater Accra Region, Ghana

Countries

Ghana

References

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.

Reference Type: DERIVED

PMID: 25739769 (View on PubMed)

Related Links

http://www.mcdconsortium.org

Malaria Capacity Development Consortium

Other Identifiers

MCDC_SF_02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ITDCVT68

Identifier Type: -

Identifier Source: org_study_id