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London School of Hygiene & Tropical Medicine Malaria Centre

Malaria clinical trials and studies

The role and cost-effectiveness of Rapid Diagnostic Tests (RDTs) in home-based management of malaria: a comparative study in two areas of high and low transmission in rural Uganda.

LSHTM investigators:
Sian Clarke, Kristian Hansen, Sham Lal Clare Chandler, Bonnie Cundill & Caroline Lynch.
External collaborators:
Richard Ndyomugyenyi (Ministry of Health, Uganda); Pascal Magnussen (DBL Centre for Health Research and Development, Denmark).
Funding body:
The Bill & Melinda Gates Foundation through the ACT Consortium.

A cluster-randomized controlled trial of use of rapid diagnostic tests (RDTs) for malaria by community medicine distributors (CMDs).

The study aims to examine the role and cost-effectiveness of RDTs in home-based management of fever in two contrasting areas of high and low malaria transmission in rural Uganda.

CMDs in the intervention arm received training in use of RDTs, and to only give antimalarial treatment after a positive test result. The training which adopted a participatory approach to build on prior knowledge and experience, also included modules on signs and symptoms of malaria, correct use of ACTs, communication, and introduced the use of rectal artesunate pre-referral treatment and referral.

The trial examines the impact and cost-effectiveness of RDT use on the proportion of patients receiving appropriate antimalarial treatment (consistent with their malaria infection status as determined against microscopy of a research slide), compared with CMDs following current practice (presumptive clinical diagnosis and treatment of fever), in each of the two contrasting areas of high and low malaria transmission.

The study also investigates the positive predictive value of RDTs used by CMDs, and perceptions and acceptability of RDTs among malaria patients, CMDs and health staff, in each transmission setting. The impact of improved malaria diagnosis on ACT adherence among patients will also be examined.