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

Ghana Health Services

Status and phase: Completed; Phase 4

Conditions: Malaria

Treatments: Procedure: Rapid Diagnostic Test

Study type: Interventional

Funder types: Other

Identifiers

NCT01907672

MCDC_SF_02 (Other Grant/Funding Number)

ITDCVT68

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 4,748 patients

Sex: All

Ages: 6+ months old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,748 participants in 2 patient groups

Rapid Diagnostic Test

Experimental group

Description:

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

Treatment:

Procedure: Rapid Diagnostic Test

No RDT

No Intervention group

Description:

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