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London School of Hygiene & Tropical Medicine Malaria Centre

Malaria clinical trials and studies

Introducing Rapid Diagnostic Tests (RDTs) into the private sector. A cluster-randomised trial among registered drug shops in Mukono district, Uganda

LSHTM investigators:
Sian Clarke, Kristian Hansen, Sham Lal, Clare Chandler, Bonnie Cundill, Caroline Lynch & Harparkash Kaur.
External collaborators:
Anthony Mbonye (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 rapid diagnostic tests (RDTs) for malaria in registered drug shops.

The study aims to examine the feasibility of introducing RDTs into registered drug shops in Uganda to encourage rational drug use in case management of malaria.

Drug shop vendors in the intervention arm received training in use of RDTs for malaria, and to only recommend 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, patient communication, and introduced the use of rectal artesunate pre-referral treatment and standardised referral forms.

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 prescription practices in control drug shops following current practice (presumptive clinical diagnosis and treatment of fever). The study also investigates perceptions and acceptability of RDTs among malaria patients and private providers, the impact of diagnostic testing on referral and the impact of improved malaria diagnosis on ACT adherence among patients. The socio-economic characteristics of patients seeking treatment for fever from registered drug shops will be described.