The Role of Rapid Diagnostic Tests for Malaria for Targeting of ACTs at Community Level: a Cluster Randomized Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Malaria
- Sponsor
- Ghana Health Services
- Enrollment
- 4748
- Locations
- 1
- Primary Endpoint
- The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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 .
Investigators
Evelyn K. Ansah
Deputy Director (Research)
Ghana Health Services
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
Outcomes
Primary Outcomes
The proportion of clients negative for malaria by double read research blood slide who received an anti-malarial in both arms
Time Frame: 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 Outcomes
- 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)
- Proportion of clients tested using a Rapid Diagnostic Test(Until the estimated sample size is obtained or up to 2 years, whichever comes first)
- Proportion of clients in each arm receiving an antibiotic(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(Until the estimated sample size is obtained or up to 2 years, whichever comes first)