Clinical trial NCT01907672: The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level
Official title: The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level: a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: Malaria
Rapid Diagnostic Tests for Malaria
Chemical Shops
Drug Shops
Diagnostics
Testing for Malaria
Lead sponsor: Ghana Health Services
Sponsor class: OTHER_GOV
Collaborators: name: London School of Hygiene and Tropical Medicine
First posted: 2013-07-25
Enrollment: 4748
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 .

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

Primary outcomes:
measure: The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms
timeFrame: Until the estimated sample size is obtained or up to 2 yrs whichever comes first
Secondary outcomes:
measure: Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm
timeFrame: Until the estimated sample size is obtained or up to 2 years, whichever comes first
measure: Proportion of clients tested using a Rapid Diagnostic Test
timeFrame: Until the estimated sample size is obtained or up to 2 years, whichever comes first
measure: Proportion of clients in each arm receiving an antibiotic
timeFrame: Until the estimated sample size is obtained or up to 2 years, whichever comes first
measure: Proportion of clients receiving addittional or alternative treatments to antimalarial and which these are
timeFrame: Until the estimated sample size is obtained or up to 2 years, whichever comes first
Other outcomes:
Locations:
city: Dodowa
country: Ghana
facility: Dodowa Health Research Centre, Ghana Health Service
state: Greater Accra
Study officials:
affiliation: Ghana Health Services
name: Evelyn K Ansah, MD,MPH,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Christopher C Whitty, BSc,MSc,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ghana Health Services
name: Margaret Gyapong, BSc,MSc,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.