Siân Clarke, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, UK. Sian.clarke@lshtm.ac.uk; tel. +44 (0)207 299 4642, + 44 (0)776 665 4045

Anthony Mbonye, Assistant Commissioner for Health, Dept. of Community Health, Ministry of Health, Kampala, Uganda. vpadmn@infocom.co.ug; tel. +256 (0)772 41 1668

Pascal Magnussen, DBL Institute for Health Research and Development, Faculty of Life Sciences, Copenhagen University, Frederiksberg, Denmark. pma@life.ku.dk; tel. +45 35 33 14 36. http://www.dbl.life.ku.dk/   

Kristian Schultz Hansen, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, UK. Kristian.Hansen@lshtm.ac.uk

Most malaria deaths occur within 48 hours of onset of symptoms, and in rural areas with poor access to health facilities, home management of malaria (HMM) can improve the timeliness of treatment and reduce malaria mortality by up to 50%. In order to maximize both coverage and impact, ACTs should be deployed in HMM programmes, as well as in formal health facilities. Up to 80% of malaria cases are treated outside the formal health sector and shops are frequently visited as the first (and in some cases only) source of treatment. Strategies to deploy ACTs in Africa thus also need to examine the role of shops in home management and to ensure that drugs sold are appropriate. The current practice of presumptive treatment of any febrile illness as malaria (both at health facilities and in the context of HMM) based solely on clinical symptoms without routine laboratory confirmation, results in significant over-use of antimalarial drugs. With ACT being a more costly regimen, it is important to be more restrictive in its administration and rapid diagnostic tests (RDTs) provide a simple means of confirming malaria diagnosis in remote locations lacking electricity and qualified health staff.  This study therefore proposes to evaluate the feasibility, acceptability, and cost-effectiveness of using RDTs to improve malaria diagnosis and treatment by local shops and pharmacies. The acceptability of this approach will be evaluated in an area with high transmission.

This study aims to examine the feasibility of introducing RDTs into drug shops in Uganda to encourage rational drug use in case management of malaria, with a focus on the correct use and adherence to ACTs. Study outcomes will assess drug prescription practices in drug shops and public health services, as well as treatment-seeking behaviour by local communities, including sources of drug treatment, consumer preferences, demand for improved diagnosis, and use of ACTs. The study also examines differences in utilization between households and ability of the approach to improve quality of diagnosis and treatment, especially amongst the poorest members of society.

It is hypothesised that the use of diagnostic testing will reduce over-diagnosis and over-prescription of antimalarial drugs in the private sector. It is further hypothesised that the availability of diagnostic testing in drug shops and confirmation of malaria will increase uptake and sale of ACT combinations (rather than monotherapy or cheaper, less efficacious, antimalarial drugs), and may also encourage purchase of the full treatment dose, as well as patient adherence to the full course of ACT treatment.

A cluster-randomised trial of use of RDTs in home management of malaria is being undertaken in Mukono district, Uganda. Clusters of registered drug shops were randomized to receive subsidized RDTs for diagnostic testing of customers presenting with fever and other signs of malaria. Drug shops in the control arm treat malaria according to presumptive diagnosis based on signs and symptoms. All drug shops participating in the trial are also be supplied with subsidized ACTs, and rectal artesunate for pre-referral treatment of severe malaria. Drug shop vendors in all participating outlets attended a 4-day training workshop in malaria diagnosis, treatment and referral in October 2010; and the intervention began in November 2010.

The intervention study is underway, and a total 11,009 patients have been recruited from both the control (5191) and intervention clusters (5818). Routine reporting of diagnosis and treatment is ongoing, with the data indicating that drug shop vendors' adherence to RDT results has been high at more than 90% since the outset of the study. The trial has now entered the final full evaluation phase with household interviews to aiming to capture data on treatment costs borne by the household, adherence to ACTs by patients, uptake of referral advice for cases of severe malaria, as well as for cases with other illnesses which cannot be treated by drug shops.