A Phase 4 interventional study of Rapid Diagnostic Test in Malaria, sponsored by Ghana Health Services. Completed at 1 site in Ghana. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2013-07-25.
Sponsored by Ghana Health Services · Phase 4, Interventional, and Diagnostic
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.
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 .
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 4,748 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Ghana Health Services is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rapid Diagnostic Test for malaria to direct antimalarial dispensing decisions in Chemical Shops
Procedure: Rapid Diagnostic Test
Chemical sellers dispense antimalarials as per their own decisions without the benefit of test results
Rapid Diagnostic Test for Malaria carried out to direct antimalarial dispensing. No antimalarials for negative tests, antimalarials for positive tests
Also known as: mRDT, RDT for malaria, RDT
The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms
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
Time frame: Until the estimated sample size is obtained or up to 2 yrs whichever comes first
Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm
Out of all clients who test negative by RDT, number who receive an antimalarial
Time frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first
Proportion of clients tested using a Rapid Diagnostic Test
The number of clients who agree to be tested with an RDT Out of all clients who meet inclusion criteria
Time frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first
Proportion of clients in each arm receiving an antibiotic
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
Time frame: 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
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
Time frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ghana Health Services