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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01907672
Acronym
GhanaCommRDT
Enrollment
4748
Registered
2013-07-25
Start date
2011-08-31
Completion date
2013-04-30
Last updated
2013-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

Malaria, Rapid Diagnostic Tests for Malaria, Chemical Shops, Drug Shops, Diagnostics, Testing for Malaria

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 .

Interventions

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

Sponsors

London School of Hygiene and Tropical Medicine
CollaboratorOTHER
Ghana Health Services
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both armsUntil the estimated sample size is obtained or up to 2 yrs whichever comes firstOut 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

MeasureTime frameDescription
Proportion of mRDT -ve clients who received an anti-malarial in the RDT armUntil the estimated sample size is obtained or up to 2 years, whichever comes firstOut of all clients who test negative by RDT, number who receive an antimalarial
Proportion of clients tested using a Rapid Diagnostic TestUntil the estimated sample size is obtained or up to 2 years, whichever comes firstThe 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 antibioticUntil the estimated sample size is obtained or up to 2 years, whichever comes firstThe 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 areUntil the estimated sample size is obtained or up to 2 years, whichever comes firstThe number of clients who receive additional or alternative treatments in the intervention and control arms out of the total number recruited into both arms

Countries

Ghana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026