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Background: Private sector drug shops are an important source of malaria treatment in Africa, yet diagnosis without parasitological testing is common among these providers. Accurate rapid diagnostic tests for malaria (mRDTs) require limited training and present an opportunity to increase access to correct diagnosis. The present study was a cost-effectiveness analysis of the introduction of mRDTs in Ugandan drug shops. Methods: Drug shop vendors were trained to perform and sell subsidised mRDTs and artemisinin-based combination therapies (ACTs) in the intervention arm while vendors offered ACTs following presumptive diagnosis of malaria in the control arm. The effect on the proportion of customers with fever ‘appropriately treated of malaria with ACT’ was captured during a randomised trial in drug shops in Mukono District, Uganda. Health sector costs included: training of drug shop vendors, community sensitisation, supervision and provision of mRDTs and ACTs to drug shops. Household costs of treatment-seeking were captured in a representative sample of drug shop customers. Findings: The introduction of mRDTs in drug shops was associated with a large improvement of diagnosis and treatment of malaria, resulting in low incremental costs for the health sector at US$0.55 per patient appropriately treated of malaria. High expenditure on non-ACT drugs by households contributed to higher incremental societal costs of US$3.83. Sensitivity analysis showed that mRDTs would become less cost-effective compared to presumptive diagnosis with increasing malaria prevalence and lower adherence to negative mRDT results. Conclusion: mRDTs in drug shops improved the targeting of ACTs to malaria patients and are likely to be considered cost-effective compared to presumptive diagnosis, although the increased costs borne by households when the test result is negative are a concern. [ABSTRACT FROM AUTHOR]

Background: The presumptive approach of confirming malaria in health facilities leads to over-diagnosis of malaria, over use of anti-malaria drugs and the risk of drug resistance development. WHO recommends parasitological confirmation before treatment with artemisinin-based combination therapy (ACT) in all suspected malaria patients. The use of malaria rapid diagnostic tests (mRDTs) would make it possible for prescribers to diagnose malaria at point-of-care and better target the use of antimalarials. Therefore, a cost-effectiveness analysis was performed on the introduction of mRDTs for management of malaria in under-five children in a high transmission area in Ghana where presumptive diagnosis was the norm in public health centres. Methods: A cluster-randomised controlled trial where thirty-two health centres were randomised into test-based diagnosis of malaria using mRDTs (intervention) or clinical judgement (control) was used to measure the effect of mRDTs on appropriate treatment: ‘a child with a positive reference diagnosis prescribed a course of ACT or a child with a negative reference diagnosis not given an ACT’. Cost data was collected from five purposively selected health centres and used to estimate the health sector costs of performing an mRDT and treat children for malaria and other common febrile illnesses. Costs of training healthcare personnel and supervision in the study period were also collected. A sample of caregivers to children participating in the trial was interviewed about household cost incurred on transport, drugs, fees, and special food during a period of one week after the health centre visit as well as days unable to work. A decision model approach was used to calculate the incremental cost-effectiveness ratios (ICERs). Univariate and multivariate sensitivity analyses were applied to assess the robustness of ICERs. Results: The availability of mRDTs for malaria diagnosis resulted in fewer ACT treatments compared to the clinical judgement approach (73% versus 81%) and more children appropriately treated (70% versus 57%). The introduction of mRDT-based diagnosis would cost the Ministry of Health US$18.6 per extra appropriately treated child under five compared to clinical judgement while the ICER from a societal perspective was lower at US$11.0 per appropriately treated child. ICERs were sensitive to a decrease in adherence to negative mRDTs, malaria positivity rate and specificity of the mRDT. Conclusion: The introduction of mRDTs is likely to be considered cost-effective in this high transmission setting as this intervention increased the number of appropriately treated children at low cost. Trial Registration: ClinicalTrials.gov [ABSTRACT FROM AUTHOR]

Abstract: Pregnant women and their unborn children are vulnerable to malaria, increasing the risk of maternal anaemia, low birthweight (LBW) and intrauterine growth retardation. There is little evidence on the cost-effectiveness of intermittent preventive treatment in pregnancy (IPTp) and insecticide-treated bednets (ITN) in areas of low transmission. A randomised controlled trial with three arms was conducted in antenatal clinics in Kabale District (Uganda), an epidemic-prone highland area of low malaria transmission. The interventions were: (i) IPTp with sulfadoxine/pyrimethamine (SP) given twice during pregnancy (IPTp-SP); (ii) ITNs alone; and (iii) a combined intervention with both ITNs and IPTp-SP. Primary health outcomes were LBW and maternal anaemia. The costs of providing IPTp-SP and ITNs as well as treatment of malaria episodes were captured from all health centres in the study area. There were no significant differences in health outcomes among the three interventions. The cost-effectiveness analysis and sensitivity analyses performed did not provide convincing support for replacing IPTp-SP (current policy) by ITNs alone or by a combined intervention in this low-transmission setting on economic grounds. The cost per pregnant woman of providing the services was lowest for the IPTp-SP intervention (US$0.79 per woman) followed by ITNs (US$1.71) and the combined intervention of IPTp-SP+ITNs (US$2.48). The relative cost-effectiveness of antenatal distribution of ITNs might improve if the cost savings accruing from continued use of a long-lasting insecticidal net after pregnancy as well as positive externalities were also taken into account, and this warrants further study. [ClinicalTrials.gov identifier: NCT00142207] [Copyright &y& Elsevier]