The impact of retail-sector delivery of artemether-lumefantrine on malaria treatment of children under five in Kenya: a cluster randomized controlled trial.

BACKGROUND: It has been proposed that artemisinin-based combination therapy (ACT) be subsidised in the private sector in order to improve affordability and access. This study in western Kenya aimed to evaluate the impact of providing subsidized artemether-lumefantrine (AL) through retail providers on the coverage of prompt, effective antimalarial treatment for febrile children aged 3-59 months. METHODS AND FINDINGS: We used a cluster-randomized, controlled design with nine control and nine intervention sublocations, equally distributed across three districts in western Kenya. Cross-sectional household surveys were conducted before and after the delivery of the intervention. The intervention comprised provision of subsidized packs of paediatric ACT to retail outlets, training of retail outlet staff, and community awareness activities. The primary outcome was defined as the proportion of children aged 3-59 months reporting fever in the past 2 weeks who started treatment with AL on the same day or following day of fever onset. Data were collected using structured questionnaires and analyzed based on cluster-level summaries, comparing control to intervention arms, while adjusting for other covariates. Data were collected on 2,749 children in the target age group at baseline and 2,662 at follow-up. 29% of children experienced fever within 2 weeks before the interview. At follow-up, the percentage of children receiving AL on the day of fever or the following day had risen by 14.6% points in the control arm (from 5.3% [standard deviation (SD): 3.2%] to 19.9% [SD: 10.0%]) and 40.2% points in the intervention arm (from 4.7% [SD: 3.4%] to 44.9% [SD: 11.7%]). The percentage of children receiving AL was significantly greater in the intervention arm at follow-up, with a difference between the arms of 25.0% points (95% confidence interval [CI]: 14.1%, 35.9%; unadjusted p = 0.0002, adjusted p = 0.0001). No significant differences were observed between arms in the proportion of caregivers who sought treatment for their child's fever by source, or in the child's adherence to AL. CONCLUSIONS: Subsidizing ACT in the retail sector can significantly increase ACT coverage for reported fevers in rural areas. Further research is needed on the impact and cost-effectiveness of such subsidy programmes at a national scale. TRIAL REGISTRATION: Current Controlled Trials ISRCTN59275137 and Kenya Pharmacy and Poisons Board Ethical Committee for Clinical Trials PPB/ECCT/08/07.

Data safety and monitoring boards for African clinical trials.

The recent increase in funding for diseases endemic in resource-poor countries has led to a progressive rise in the number of trials conducted in Africa for product development purposes or to answer important questions on reduction of disease burden. This causes an increasing demand for data safety monitoring boards (DSMBs) within Africa, where there is currently a shortage of appropriately skilled people. To address this, and in line with capacity-building efforts directed at improved quality research, AMANET invited the authors to create a curriculum and to train selected Africans with the skills required for members of DSMBs. Based on experience, the facilitators made an overview of clinical trial designs, a comprehensive review of data safety monitoring guidelines and other relevant DSMB governance issues. The wealth of guidelines and recommendations available for establishing and running DSMBs focus mainly on trials set in developed countries. The authors drew from these guidelines a practical summary of those relevant for Africa. This interactive process enabled recommendation of a straightforward set of principles to guide the establishment of DSMBs in Africa, which strike that essential balance between protecting trial participants and allowing investigators to answer their scientific questions.