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      The effect of an anti-malarial subsidy programme on the quality of service provision of artemisinin-based combination therapy in Kenya: a cluster-randomized, controlled trial


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          Many patients with suspected malaria in sub-Saharan Africa seek treatment from private providers, but this sector suffers from sub-standard medicine dispensing practices. To improve the quality of care received for presumptive malaria from the highly accessed private retail sector in western Kenya, subsidized pre-packaged artemether-lumefantrine (AL) was provided to private retailers, together with a one day training for retail staff on malaria diagnosis and treatment, job aids and community engagement activities.


          The intervention was assessed using a cluster-randomized, controlled design. Provider and mystery-shopper cross-sectional surveys were conducted at baseline and eight months post-intervention to assess provider practices. Data were analysed based on cluster-level summaries, comparing control and intervention arms.


          On average, 564 retail outlets were interviewed per year. At follow-up, 43% of respondents reported that at least one staff member had attended the training in the intervention arm. The intervention significantly increased the percentage of providers knowing the first line treatment for uncomplicated malaria by 24.2% points (confidence interval (CI): 14.8%, 33.6%; adjusted p=0.0001); the percentage of outlets stocking AL by 31.7% points (CI: 22.0%, 41.3%; adjusted p=0.0001); and the percentage of providers prescribing AL for presumptive malaria by 23.6% points (CI: 18.7%, 28.6%; adjusted p=0.0001). Generally outlets that received training and job aids performed better than those receiving one or none of these intervention components.


          Overall, subsidizing ACT and retailer training can significantly increase the percentage of outlets stocking and selling AL for the presumptive treatment of malaria, but further research is needed on strategies to improve the provision of counselling advice to retail customers.

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          Sample size calculations for cluster randomised controlled trials with a fixed number of clusters

          Abstract Background Cluster randomised controlled trials (CRCTs) are frequently used in health service evaluation. Assuming an average cluster size, required sample sizes are readily computed for both binary and continuous outcomes, by estimating a design effect or inflation factor. However, where the number of clusters are fixed in advance, but where it is possible to increase the number of individuals within each cluster, as is frequently the case in health service evaluation, sample size formulae have been less well studied. Methods We systematically outline sample size formulae (including required number of randomisation units, detectable difference and power) for CRCTs with a fixed number of clusters, to provide a concise summary for both binary and continuous outcomes. Extensions to the case of unequal cluster sizes are provided. Results For trials with a fixed number of equal sized clusters (k), the trial will be feasible provided the number of clusters is greater than the product of the number of individuals required under individual randomisation (nI ) and the estimated intra-cluster correlation (ρ). So, a simple rule is that the number of clusters (k) will be sufficient provided: Where this is not the case, investigators can determine the maximum available power to detect the pre-specified difference, or the minimum detectable difference under the pre-specified value for power. Conclusions Designing a CRCT with a fixed number of clusters might mean that the study will not be feasible, leading to the notion of a minimum detectable difference (or a maximum achievable power), irrespective of how many individuals are included within each cluster.
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            A critical review of behavioral issues related to malaria control in sub-Saharan Africa: what contributions have social scientists made?

            In 1996, Social Science & Medicine published a review of treatment seeking for malaria (McCombie, 1996). Since that time, a significant amount of socio-behavioral research on the home management of malaria has been undertaken. In addition, recent initiatives such as Roll Back Malaria have emphasized the importance of social science inputs to malaria research and control. However, there has been a growing feeling that the potential contributions that social science could and should be making to malaria research and control have yet to be fully realized. To address these issues, this paper critically reviews and synthesizes the literature (published, unpublished and technical reports) pertaining to the home management of illness episodes of malaria in sub-Saharan Africa from 1996 to the end of 2000, and draws conclusions about the use of social science in malaria research and control. The results suggest that while we have amassed increasing quantities of descriptive data on treatment seeking behavior, we still have little understanding of the rationale of drug use from the patient perspective and, perhaps more importantly, barely any information on the rationale of provider behaviors. However, the results underline the dynamic and iterative nature of treatment seeking with multiple sources of care frequently being employed during a single illness episode; and highlight the importance in decision making of gender, socio-economic and cultural position of individuals within households and communities. Furthermore, the impact of political, structural and environmental factors on treatment seeking behaviors is starting to be recognised. Programs to address these issues may be beyond single sector (malaria control programme) interventions, but social science practice in malaria control needs to reflect a realistic appraisal of the complexities that govern human behavior and include critical appraisal and proposals for practical action. Major concerns arising from the review were the lack of evidence of 'social scientist' involvement (particularly few from endemic countries) in much of the published research; and concerns with methodological rigor. To increase the effective use of social science, we should focus on a new orientation for field research (including increased methodological rigor), address the gaps in research knowledge, strengthen the relationship between research, policy and practice; and concentrate on capacity strengthening and advocacy. Copyright 2003 Elsevier Ltd.
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              Monitoring fever treatment behaviour and equitable access to effective medicines in the context of initiatives to improve ACT access: baseline results and implications for programming in six African countries

              Background Access to artemisinin-based combination therapy (ACT) remains limited in high malaria-burden countries, and there are concerns that the poorest people are particularly disadvantaged. This paper presents new evidence on household treatment-seeking behaviour in six African countries. These data provide a baseline for monitoring interventions to increase ACT coverage, such as the Affordable Medicines Facility for malaria (AMFm). Methods Nationally representative household surveys were conducted in Benin, the Democratic Republic of Congo (DRC), Madagascar, Nigeria, Uganda and Zambia between 2008 and 2010. Caregivers responded to questions about management of recent fevers in children under five. Treatment indicators were tabulated across countries, and differences in case management provided by the public versus private sector were examined using chi-square tests. Logistic regression was used to test for association between socioeconomic status and 1) malaria blood testing, and 2) ACT treatment. Results Fever treatment with an ACT is low in Benin (10%), the DRC (5%), Madagascar (3%) and Nigeria (5%), but higher in Uganda (21%) and Zambia (21%). The wealthiest children are significantly more likely to receive ACT compared to the poorest children in Benin (OR = 2.68, 95% CI = 1.12-6.42); the DRC (OR = 2.18, 95% CI = 1.12-4.24); Madagascar (OR = 5.37, 95% CI = 1.58-18.24); and Nigeria (OR = 6.59, 95% CI = 2.73-15.89). Most caregivers seek treatment outside of the home, and private sector outlets are commonly the sole external source of treatment (except in Zambia). However, children treated in the public sector are significantly more likely to receive ACT treatment than those treated in the private sector (except in Madagascar). Nonetheless, levels of testing and ACT treatment in the public sector are low. Few caregivers name the national first-line drug as most effective for treating malaria in Madagascar (2%), the DRC (2%), Nigeria (4%) and Benin (10%). Awareness is higher in Zambia (49%) and Uganda (33%). Conclusions Levels of effective fever treatment are low and inequitable in many contexts. The private sector is frequently accessed however case management practices are relatively poor in comparison with the public sector. Supporting interventions to inform caregiver demand for ACT and to improve provider behaviour in both the public and private sectors are needed to achieve maximum gains in the context of improved access to effective treatment.

                Author and article information

                Malar J
                Malar. J
                Malaria Journal
                BioMed Central
                1 March 2013
                : 12
                : 81
                [1 ]Malaria Public Health Department, Kenya Medical Research Institute-Wellcome Trust Research Programme, Nairobi, Kenya
                [2 ]Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, CCVTM, Oxford, UK
                [3 ]Division of Malaria Control, Ministry of Public Health and Sanitation, Nairobi, Kenya
                [4 ]Pharmacy and Poisons Board, Nairobi, Kenya
                [5 ]London School of Hygiene and Tropical Medicine, London, UK
                Copyright © 2013 Kangwana et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                : 16 November 2012
                : 18 February 2013

                Infectious disease & Microbiology
                community case-management of malaria,artemisinin-based combination therapy,antimalarial subsidy programme,drug retailers


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