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

Phase 4

Completed

• Conditions: Malaria
• Interventions: Procedure: Rapid Diagnostic Test

• Registration Number: NCT01907672
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-09-02
• Primary Completion: 2012-12
• Study Completion: 2013-04
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-22
• Last Update Submitted: 2013-07-22
• Study First Posted: 2013-07-25
• Last Update Posted: 2013-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4748

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms	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

Name	Time	Method
Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm	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
Proportion of clients tested using a Rapid Diagnostic Test	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
Proportion of clients in each arm receiving an antibiotic	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
Proportion of clients receiving addittional or alternative treatments to antimalarial and which these are	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

Trial Locations

Locations (1)

Dodowa Health Research Centre, Ghana Health Service; 🇬🇭 Dodowa, Greater Accra, Ghana