Introducing rapid diagnostic tests for malaria to drug shops in Uganda: a cluster-randomized controlled trial

In areas where malaria is endemic, the appropriate management of febrile illness and the effective use of resources for malaria control rely on the availability and use of diagnostic tests.1 In the absence of diagnostic tests, antimalarial drugs are often taken for illnesses that have similar symptoms to those of malaria.2–5 Failure to diagnose malaria can lead to poor case management, a waste of scarce health resources and increased risk of antimalarial resistance.1,6 The non-treatment or delayed treatment of malaria contribute substantially to malaria-attributable child mortality.7,8 In Uganda, only a minority of febrile illnesses are treated with artemisinin combination therapy – i.e. the recommended first-line treatment for malaria – and many of such episodes go untreated.9 Similar observations have been made in Kenya, the United Republic of Tanzania and other African countries.10–13 The World Health Organization (WHO) recommends parasitological confirmation of malaria before antimalarial drug use.14 Although the current Global malaria action plan of the Roll Back Malaria Initiative calls for universal access to malaria testing,15 such access remains a distant goal in most countries with endemic malaria. A study in six African countries found that only 4–31% of children with febrile illnesses were tested for malaria.9 In many countries, patients and caregivers rely heavily on a loosely regulated private sector for malaria treatment.16,17 In consequence, the engagement of the private sector has become an increasingly common strategy in malaria control programmes – as reflected, for example, in the pilot Affordable Medicines Facility–malaria (AMFm).18 The development of inexpensive and simple rapid diagnostic tests for malaria has opened the possibility of widespread access to malaria diagnosis. These antigen detection tests have been shown to be as effective as routine microscopy in malaria diagnosis19 and can be safely performed by individuals with only basic training.20 Although research from Cambodia,21 Somalia22 and Uganda23 has shown that the distribution of rapid diagnostic tests by the private sector is feasible, we know very little of the impact of this approach on population-level rates of malaria diagnosis and purchase of antimalarial drugs. We therefore conducted a trial in eastern Uganda to investigate the impact – on malaria diagnosis and the purchase of antimalarial drugs – of training the vendors from licensed drug shops to test patients with a rapid diagnostic test for malaria. The trained vendors were also encouraged to buy the test, at a subsidized price, from local wholesale providers. The study took place in Uganda’s eastern region, where the annual transmission rates for malaria exceed 100 infective bites per person24 and presumptive symptom-based treatment remains common – especially when, as commonly occurs, treatment is sought outside the higher level public-health facilities.25–27 Malaria is responsible for 30–50% of outpatient visits and 9–14% of inpatient deaths in Uganda.28 Objective To evaluate the impact – on diagnosis and treatment of malaria – of introducing rapid diagnostic tests to drug shops in eastern Uganda. Methods Overall, 2193 households in 79 study villages with at least one licensed drug shop were enrolled and monitored for 12 months. After 3 months of monitoring, drug shop vendors in 67 villages randomly selected for the intervention were offered training in the use of malaria rapid diagnostic tests and – if trained – offered access to such tests at a subsidized price. The remaining 12 study villages served as controls. A difference-in-differences regression model was used to estimate the impact of the intervention. Findings Vendors from 92 drug shops successfully completed training and 50 actively stocked and performed the rapid tests. Over 9 months, trained vendors did an average of 146 tests per shop. Households reported 22 697 episodes of febrile illness. The availability of rapid tests at local drug shops significantly increased the probability of any febrile illness being tested for malaria by 23.15% (P = 0.015) and being treated with an antimalarial drug by 8.84% (P = 0.056). The probability that artemisinin combination therapy was bought increased by a statistically insignificant 5.48% (P = 0.574). Conclusion In our study area, testing for malaria was increased by training drug shop vendors in the use of rapid tests and providing them access to such tests at a subsidized price. Additional interventions may be needed to achieve a higher coverage of testing and a higher rate of appropriate responses to test results.