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

Malaria Clinical Trial

— GhanaCommRDT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907672
• Other study ID #: ITDCVT68
• Secondary ID: MCDC_SF_02
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2012
• Last updated: July 22, 2013
• Start date: August 2011
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Ghana Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Ghana Health ServiceUnited Kingdom: London School of Hygiene & Tropical MedicineUnited Kingdom : MCDC ConsortiumGhana :Pharmacy Council
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4748
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Malaria

Intervention

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

Locations

Country	Name	City	State
Ghana	Dodowa Health Research Centre, Ghana Health Service	Dodowa	Greater Accra

Sponsors (2)

Lead Sponsor	Collaborator
Ghana Health Services	London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Until the estimated sample size is obtained or up to 2 yrs whichever comes first	No
Secondary	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	Until the estimated sample size is obtained or up to 2 years, whichever comes first	No
Secondary	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	Until the estimated sample size is obtained or up to 2 years, whichever comes first	No
Secondary	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	Until the estimated sample size is obtained or up to 2 years, whichever comes first	No
Secondary	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	Until the estimated sample size is obtained or up to 2 years, whichever comes first	No

External Links

•   Malaria Capacity Development Consortium