The Impact of Retail-Sector Delivery of Artemether–Lumefantrine on Malaria Treatment of Children under Five in Kenya: A Cluster Randomized Controlled Trial
Identifieur interne : 002825 ( Pmc/Curation ); précédent : 002824; suivant : 002826The Impact of Retail-Sector Delivery of Artemether–Lumefantrine on Malaria Treatment of Children under Five in Kenya: A Cluster Randomized Controlled Trial
Auteurs : Beth P. Kangwana [Kenya] ; Sarah V. Kedenge [Kenya] ; Abdisalan M. Noor [Kenya, Royaume-Uni] ; Victor A. Alegana [Kenya] ; Andrew J. Nyandigisi [Kenya] ; Jayesh Pandit [Kenya] ; Greg W. Fegan [Kenya, Royaume-Uni] ; James E. Todd [Royaume-Uni] ; Simon Brooker [Kenya, Royaume-Uni] ; Robert W. Snow [Kenya, Royaume-Uni] ; Catherine A. Goodman [Kenya, Royaume-Uni]Source :
- PLoS Medicine [ 1549-1277 ] ; 2011.
Abstract
In a cluster randomized trial, Beth Kangwana and colleagues find that provision of subsidized packs of the malaria therapy artemether-lumefantrine to shops more than doubled the proportion of children with fever who received drugs promptly.
Url:
DOI: 10.1371/journal.pmed.1000437
PubMed: 21655317
PubMed Central: 3104978
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when="2011">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>In a cluster randomized trial, Beth Kangwana and colleagues find that provision of subsidized packs of the malaria therapy artemether-lumefantrine to shops more than doubled the proportion of children with fever who received drugs promptly.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Mccombie, Sc" uniqKey="Mccombie S">SC McCombie</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Williams, Ha" uniqKey="Williams H">HA Williams</name></author><author><name sortKey="Jones, Co" uniqKey="Jones C">CO Jones</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Laxminarayan, R" uniqKey="Laxminarayan R">R 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<front><journal-meta><journal-id journal-id-type="nlm-ta">PLoS Med</journal-id><journal-id journal-id-type="iso-abbrev">PLoS Med</journal-id><journal-id journal-id-type="publisher-id">PLoS</journal-id><journal-id journal-id-type="pmc">plosmed</journal-id><journal-title-group><journal-title>PLoS Medicine</journal-title></journal-title-group><issn pub-type="ppub">1549-1277</issn><issn pub-type="epub">1549-1676</issn><publisher><publisher-name>Public Library of Science</publisher-name><publisher-loc>San Francisco, USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">21655317</article-id><article-id pub-id-type="pmc">3104978</article-id><article-id pub-id-type="publisher-id">10-PLME-RA-5891R3</article-id><article-id pub-id-type="doi">10.1371/journal.pmed.1000437</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="Discipline"><subject>Evidence-Based Healthcare/Quality and Safety in Medical Practice</subject><subject>Infectious Diseases/Protozoal Infections</subject><subject>Public Health and Epidemiology</subject><subject>Public Health and Epidemiology/Epidemiology</subject><subject>Public Health and Epidemiology/Health Policy</subject></subj-group></article-categories><title-group><article-title>The Impact of Retail-Sector Delivery of Artemether–Lumefantrine on Malaria Treatment of Children under Five in Kenya: A Cluster Randomized Controlled Trial</article-title><alt-title alt-title-type="running-head">Access to Effective Malaria Treatment</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Kangwana</surname><given-names>Beth P.</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="corresp" rid="cor1"><sup>*</sup></xref></contrib><contrib contrib-type="author"><name><surname>Kedenge</surname><given-names>Sarah V.</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Noor</surname><given-names>Abdisalan M.</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Alegana</surname><given-names>Victor A.</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Nyandigisi</surname><given-names>Andrew J.</given-names></name><xref ref-type="aff" rid="aff3"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Pandit</surname><given-names>Jayesh</given-names></name><xref ref-type="aff" rid="aff4"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Fegan</surname><given-names>Greg W.</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Todd</surname><given-names>James E.</given-names></name><xref ref-type="aff" rid="aff5"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Brooker</surname><given-names>Simon</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff5"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Snow</surname><given-names>Robert W.</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff2"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Goodman</surname><given-names>Catherine A.</given-names></name><xref ref-type="aff" rid="aff1"><sup>1</sup></xref><xref ref-type="aff" rid="aff5"><sup>5</sup></xref></contrib></contrib-group><aff id="aff1"><label>1</label><addr-line>Malaria Public Health & Epidemiology Group, Kenya Medical Research Institute - Wellcome Trust Research Programme, Kenya</addr-line></aff><aff id="aff2"><label>2</label><addr-line>Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom</addr-line></aff><aff id="aff3"><label>3</label><addr-line>Division of Malaria Control, Ministry of Public Health and Sanitation, Nairobi, Kenya</addr-line></aff><aff id="aff4"><label>4</label><addr-line>Pharmacy and Poisons Board, Nairobi, Kenya</addr-line></aff><aff id="aff5"><label>5</label><addr-line>London School of Hygiene & Tropical Medicine, London, United Kingdom</addr-line></aff><contrib-group><contrib contrib-type="editor"><name><surname>Rogerson</surname><given-names>Stephen John</given-names></name><role>Academic Editor</role><xref ref-type="aff" rid="edit1"></xref></contrib></contrib-group><aff id="edit1">University of Melbourne, Australia</aff><author-notes><corresp id="cor1">* E-mail: <email>bkangwana@nairobi.kemri-wellcome.org</email></corresp><fn fn-type="con"><p><ext-link ext-link-type="uri" xlink:href="http://www.icmje.org/">ICMJE</ext-link> criteria for authorship read and met: BPK SVK AMN VAA AJN JP GWF JET SB RWS CAG. Agree with the manuscript's results and conclusions: BPK SVK AMN VAA AJN JP GWF JET SB RWS CAG. Designed the experiments/the study: BPK AJN GWF RWS CAG. Analyzed the data: BPK AMN AJN GWF JET CAG. Collected data/did experiments for the study: BPK SVK. Enrolled patients: BPK. Wrote the first draft of the paper: BPK. Contributed to the writing of the paper: BPK SVK AMN VAA AJN JP GWF JET SB RWS CAG. Ensured that regulatory requirements for Pharmacovigilance were met: JP. Advised on the interpretation of the study results: JET. Contributed to study design: SB. Reviewed all primary and secondary analysis: RWS.</p></fn></author-notes><pub-date pub-type="collection"><month>5</month><year>2011</year></pub-date><pub-date pub-type="epub"><day>31</day><month>5</month><year>2011</year></pub-date><volume>8</volume><issue>5</issue><elocation-id>e1000437</elocation-id><history><date date-type="received"><day>12</day><month>8</month><year>2010</year></date><date date-type="accepted"><day>18</day><month>4</month><year>2011</year></date></history><permissions><copyright-statement>Kangwana et al.</copyright-statement><copyright-year>2011</copyright-year><license xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>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 properly credited.</license-p></license></permissions><abstract abstract-type="toc"><p>In a cluster randomized trial, Beth Kangwana and colleagues find that provision of subsidized packs of the malaria therapy artemether-lumefantrine to shops more than doubled the proportion of children with fever who received drugs promptly.</p></abstract><abstract><sec><title>Background</title><p>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.</p></sec><sec><title>Methods and Findings</title><p>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 <italic>p</italic> = 0.0002, adjusted <italic>p</italic> = 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.</p></sec><sec><title>Conclusions</title><p>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.</p></sec><sec><title>Trial Registration</title><p>Current Controlled Trials <ext-link ext-link-type="uri" xlink:href="http://www.controlled-trials.com/ISRCTN59275137">ISRCTN59275137</ext-link> and Kenya Pharmacy and Poisons Board Ethical Committee for Clinical Trials PPB/ECCT/08/07.</p></sec><sec><title></title><p><italic>Please see later in the article for the Editors' Summary</italic></p></sec></abstract><abstract abstract-type="editor"><title>Editors' Summary</title><sec id="s4a1a"><title>Background</title><p>Malaria is a major global public-health problem. Half the world's population is at risk of this mosquito-borne parasitic disease, which kills a million people (mainly children living in sub-Saharan Africa) every year. Although several parasites cause malaria, <italic>Plasmodium falciparum</italic> is responsible for most of these deaths. For the past 50 years, the main treatments for malaria have been drugs such as sulfadoxine–pyrimethamine and chloroquine. Unfortunately, parasitic resistance to these inexpensive "monotherapies" is now widespread and there has been an upsurge in the illness and death caused by <italic>P. falciparum</italic>. To combat this increase, the World Health Organization (WHO) now recommends artemisinin-based combination therapy (ACT) for first-line treatment of <italic>P. falciparum</italic> malaria in all regions with drug-resistant malaria. In ACT, artemisinin derivatives (new, fast-acting antimalarial drugs) are used in combination with another antimalarial to reduce the chances of <italic>P. falciparum</italic> becoming resistant to either drug.</p></sec><sec id="s4a1b"><title>Why Was This Study Done?</title><p>Despite WHO's recommendation, ACT use in many developing countries remains low partly because of its high retail price. To increase the affordability of and access to ACT, the Global Fund to Fight AIDS, Tuberculosis and Malaria is planning to run an ACT subsidy mechanism called the “Affordable Medicines Facility – malaria” (AMF-m). Using money provided by various donors, the Global Fund aims to reduce the private sector retail costs of ACT to those of monotherapies by making "copayments" directly to ACT manufacturers. Phase I of the AMF-m is already being implemented in pilots in several countries, but there are few data on the likely impact of private sector ACT subsidies on the coverage of prompt, effective treatment at the community level. In this cluster randomized controlled trial, the researchers investigate the impact of an intervention package that includes ACT subsidies on malaria treatment of young children in a high malaria transmission area of western Kenya. In a cluster randomized controlled trial, groups of patients rather than individual patients are randomly assigned to receive a test or control intervention, and the outcomes in different clusters are compared.</p></sec><sec id="s4a1c"><title>What Did the Researchers Do and Find?</title><p>The researchers randomly assigned 18 rural sublocations (the lowest administrative level in Kenya) to receive the intervention—the provision of subsidized packs of the ACT artemether-lumefantrine (AL) to retail outlets, retail staff training, and community awareness activities—or to act as controls. The researchers collected data about recent fever (a symptom of malaria) in children aged 3–59 months and its treatment with AL from randomly selected households in the intervention and control sublocations 4 months before and 8 months after roll-out of the intervention. At follow-up, 19.9% of children in the control arm received AL within 24 hours of fever developing compared to 5.3% of children at baseline (a 14.5% point rise). In the intervention arm, the percentage of children receiving AL within 24 hours of fever developing increased from 4.7% at baseline to 44.9% at follow-up (a 40.2% point rise). Moreover, the proportion of children receiving AL in the intervention arm was significantly greater than in the control arm (that is, unlikely to have happened by chance). Put another way, the intervention more than doubled the proportion of children with fever who received AL promptly.</p></sec><sec id="s4a1d"><title>What Do These Findings Mean?</title><p>These findings show that in the rural areas of Kenya included in this study, the provision of subsidized ACT in the private retail sector can significantly increase the coverage of prompt and effective treatment of fever in children with ACT; the increase in ACT coverage in the control arm probably reflects improved availability of AL in public-health facilities. However, these findings may not be generalizable to other settings and, because the design of this trial and that of the planned AMF-m roll-out are somewhat different (through AMF-m, subsidized drugs will be available to all age groups, for example), these results must be used with caution when trying to predict the outcome of AMF-m. Most importantly, the tested intervention only achieved prompt ACT uptake in 44.9% of children with fever, somewhat lower than the target of 80% set by the Roll Back Malaria Partnership. Thus, although the provision of subsidized ACTs is likely to improve ACT coverage, additional strategies to increase the prompt use of ACT need to be identified.</p></sec><sec id="s4a1e"><title>Additional Information</title><p>Please access these Web sites via the online version of this summary at <ext-link ext-link-type="uri" xlink:href="http://dx.doi.org/10.1371/journal.pmed.1000437">http://dx.doi.org/10.1371/journal.pmed.1000437</ext-link>.</p><list list-type="bullet"><list-item><p>Information is available from the World Health Organization on <ext-link ext-link-type="uri" xlink:href="http://www.who.int/topics/malaria/en">malaria</ext-link> (in several languages); the <ext-link ext-link-type="uri" xlink:href="http://www.who.int/malaria/world_malaria_report_2010/en/index.html">2010 World Malaria Report</ext-link> provides details of the current global malaria situation</p></list-item><list-item><p>The US Centers for Disease Control and Prevention provide information on <ext-link ext-link-type="uri" xlink:href="http://www.cdc.gov/malaria">malaria</ext-link> (in English and Spanish)</p></list-item><list-item><p>Information is available from the Roll Back Malaria Partnership on the <ext-link ext-link-type="uri" xlink:href="http://www.rollbackmalaria.org">global control of malaria</ext-link> including fact sheets about <ext-link ext-link-type="uri" xlink:href="http://rbm.who.int/cmc_upload/0/000/015/364/RBMInfosheet_9.htm">ACT</ext-link> and about <ext-link ext-link-type="uri" xlink:href="http://www.who.int/malaria/publications/country-profiles/2009/mal2009_kenya_0025.pdf">malaria in Kenya</ext-link>, and information on <ext-link ext-link-type="uri" xlink:href="http://www.rollbackmalaria.org/psm/amfm.html">AMF-m</ext-link></p></list-item><list-item><p><ext-link ext-link-type="uri" xlink:href="http://www.theglobalfund.org/en/">The Global Fund to Fight AIDS, Tuberculosis and Malaria</ext-link>, an international financing institution that invests the world's money to save lives, also has information on <ext-link ext-link-type="uri" xlink:href="http://www.theglobalfund.org/en/malaria/?lang=en">fighting malaria</ext-link> and on the <ext-link ext-link-type="uri" xlink:href="http://www.theglobalfund.org/en/amfm/(in">AMF-m</ext-link> (in several languages)</p></list-item><list-item><p>MedlinePlus provides links to additional information on <ext-link ext-link-type="uri" xlink:href="http://www.nlm.nih.gov/medlineplus/malaria.html">malaria</ext-link> (in English and Spanish)</p></list-item></list></sec></abstract><counts><page-count count="14"></page-count></counts></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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