Giuseppe
Emeritus
[Source: PLoS Medicine, full text: (LINK). Abstract, edited.]
The Impact of Retail-Sector Delivery of Artemether–Lumefantrine on Malaria Treatment of Children under Five in Kenya: A Cluster Randomized Controlled Trial
Beth P. Kangwana<SUP>1</SUP><SUP>*</SUP>, Sarah V. Kedenge<SUP>1</SUP>, Abdisalan M. Noor<SUP>1</SUP><SUP>,</SUP><SUP>2</SUP>, Victor A. Alegana<SUP>1</SUP>, Andrew J. Nyandigisi<SUP>3</SUP>, Jayesh Pandit<SUP>4</SUP>, Greg W. Fegan<SUP>1</SUP><SUP>,</SUP><SUP>2</SUP>, James E. Todd<SUP>5</SUP>, Simon Brooker<SUP>1</SUP><SUP>,</SUP><SUP>5</SUP>, Robert W. Snow<SUP>1</SUP><SUP>,</SUP><SUP>2</SUP>, Catherine A. Goodman<SUP>1</SUP><SUP>,</SUP><SUP>5</SUP>
1 Malaria Public Health & Epidemiology Group, Kenya Medical Research Institute - Wellcome Trust Research Programme, Kenya, 2 Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom, 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 & Tropical Medicine, London, United Kingdom
Abstract
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.
Please see later in the article for the Editors' Summary
Citation: Kangwana BP, Kedenge SV, Noor AM, Alegana VA, Nyandigisi AJ, et al. (2011) The Impact of Retail-Sector Delivery of Artemether–Lumefantrine on Malaria Treatment of Children under Five in Kenya: A Cluster Randomized Controlled Trial. PLoS Med 8(5): e1000437. doi:10.1371/journal.pmed.1000437
Academic Editor: Stephen John Rogerson, University of Melbourne, Australia
Received: August 12, 2010; Accepted: April 18, 2011; Published: May 31, 2011
Copyright: © 2011 Kangwana et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This work was financially supported by the Department for International Development, UK (DFID), the United States Agency for International Development (USAID), the Wellcome Trust, UK, and the Kenya Medical Research Institute (KEMRI). AMN is supported by the Wellcome Trust as a Research Training Fellow (#081829), RWS is a Principal Wellcome Trust Fellow (#079081), SB is supported by a Research Career Development Fellowship from the Wellcome Trust (#0811673), and CAG is a member of the Consortium for Research on Equitable Health Systems, which is supported by the UK Department for International Development. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: RWS chairs the Novartis National Malaria Control Programme Managers "Best Practice Workshops" in Africa for which he receives an honorarium.
Abbreviations: ACT, artemisinin-based combination therapy; ADR, adverse drug reaction; AL, artemether–lumefantrine; AMF-m, Affordable Medicines Facility-malaria; CI, confidence interval; CMD, community medicine distributor; EA, enumeration area; ITN, insecticide-treated net; PCA, principal components analysis; PPB, Pharmacy and Poisons Board; PSI, Population Services International; SD, standard deviation; SP, sulphadoxine–pyrimethamine
* E-mail: bkangwana@nairobi.kemri-wellcome.org
- -------Beth P. Kangwana<SUP>1</SUP><SUP>*</SUP>, Sarah V. Kedenge<SUP>1</SUP>, Abdisalan M. Noor<SUP>1</SUP><SUP>,</SUP><SUP>2</SUP>, Victor A. Alegana<SUP>1</SUP>, Andrew J. Nyandigisi<SUP>3</SUP>, Jayesh Pandit<SUP>4</SUP>, Greg W. Fegan<SUP>1</SUP><SUP>,</SUP><SUP>2</SUP>, James E. Todd<SUP>5</SUP>, Simon Brooker<SUP>1</SUP><SUP>,</SUP><SUP>5</SUP>, Robert W. Snow<SUP>1</SUP><SUP>,</SUP><SUP>2</SUP>, Catherine A. Goodman<SUP>1</SUP><SUP>,</SUP><SUP>5</SUP>
1 Malaria Public Health & Epidemiology Group, Kenya Medical Research Institute - Wellcome Trust Research Programme, Kenya, 2 Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom, 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 & Tropical Medicine, London, United Kingdom
Abstract
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.
Please see later in the article for the Editors' Summary
Citation: Kangwana BP, Kedenge SV, Noor AM, Alegana VA, Nyandigisi AJ, et al. (2011) The Impact of Retail-Sector Delivery of Artemether–Lumefantrine on Malaria Treatment of Children under Five in Kenya: A Cluster Randomized Controlled Trial. PLoS Med 8(5): e1000437. doi:10.1371/journal.pmed.1000437
Academic Editor: Stephen John Rogerson, University of Melbourne, Australia
Received: August 12, 2010; Accepted: April 18, 2011; Published: May 31, 2011
Copyright: © 2011 Kangwana et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: This work was financially supported by the Department for International Development, UK (DFID), the United States Agency for International Development (USAID), the Wellcome Trust, UK, and the Kenya Medical Research Institute (KEMRI). AMN is supported by the Wellcome Trust as a Research Training Fellow (#081829), RWS is a Principal Wellcome Trust Fellow (#079081), SB is supported by a Research Career Development Fellowship from the Wellcome Trust (#0811673), and CAG is a member of the Consortium for Research on Equitable Health Systems, which is supported by the UK Department for International Development. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: RWS chairs the Novartis National Malaria Control Programme Managers "Best Practice Workshops" in Africa for which he receives an honorarium.
Abbreviations: ACT, artemisinin-based combination therapy; ADR, adverse drug reaction; AL, artemether–lumefantrine; AMF-m, Affordable Medicines Facility-malaria; CI, confidence interval; CMD, community medicine distributor; EA, enumeration area; ITN, insecticide-treated net; PCA, principal components analysis; PPB, Pharmacy and Poisons Board; PSI, Population Services International; SD, standard deviation; SP, sulphadoxine–pyrimethamine
* E-mail: bkangwana@nairobi.kemri-wellcome.org