Skip to main content
OpenTrials
Completed

NCT Number: NCT01907672

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dodowa Health Research Centre, Ghana Health Service

Dodowa, Greater Accra Region, Box DD1, Ghana

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid Diagnostic Test

Procedure

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

Other names: mRDT, RDT for malaria, RDT

Primary outcomes

  1. 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

  1. Proportion of mRDT -ve clients who received an anti-malarial in the RDT arm

    Time frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first

    Out of all clients who test negative by RDT, number who receive an antimalarial

  2. Proportion of clients tested using a Rapid Diagnostic Test

    Time frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first

    The number of clients who agree to be tested with an RDT Out of all clients who meet inclusion criteria

  3. Proportion of clients in each arm receiving an antibiotic

    Time frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first

    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

  4. Proportion of clients receiving addittional or alternative treatments to antimalarial and which these are

    Time frame: Until the estimated sample size is obtained or up to 2 years, whichever comes first

    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

Sponsors and collaborators

Lead sponsor

Ghana Health Services

Other Gov

Collaborators

  • London School of Hygiene and Tropical Medicine

Registry information

Official study title

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

Acronym: GhanaCommRDT

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 25, 2013
Registry last updated
Jul 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.