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ISRCTN
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ISRCTN59275137
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ClinicalTrials.gov identifier
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Public title
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To assess whether providing Kenya’s first line anti-malarial treatment in shops at a subsidised price can increase the share of young children who receive appropriate treatment for malaria
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Scientific title
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The impact of retail sector delivery of artemether-lumefantrine on effective malaria treatment of children under five in Kenya
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Acronym
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N/A
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Serial number at source
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SSC 1361
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Study hypothesis
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Null hypothesis:
The provision of pre-packaged, subsidised artemether-lumefantrine (AL) delivered through private sector retailers will have no effect on improving the coverage of prompt effective anti-malarial treatment.
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Ethics approval
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Ethics approval received from:
1. Kenya Medical Research Institute (KEMRI) Ethical Review Committee (ERC) (Scientific Steering Committee [SSC] ref: 1361) on the 23rd April 2008. Approval was granted from 23rd March 2008 to 23rd March 2009. Application for an approval extension will be done in early 2009.
2. London School of Hygiene and Tropical Medicine (LSHTM) ERC received March 2008 (ref: 5288)
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Study design
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Interventional, pre-post randomised cluster controlled trial
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Countries of recruitment
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Kenya
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Disease/condition/study domain
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Malaria
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Participants - inclusion criteria
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1. All children under five years of age (either sex) from whom care is sought for fever from participating retail shops serving the population in the intervention sub-locations
2. Selected retail outlets either within or serving the intervention sub-locations which are perceived to be well established, respected businesses by the local community, who stock anti-malarials or anti-pyretics and have been functioning for a specified minimum amount of time (time of functioning to be determined following baseline retail census)
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Participants - exclusion criteria
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1. Children under 5 kg suffering from Integrated Management of Childhood Illness (IMCI) danger signs. These children will be referred directly to a health facility.
2. Retail shops serving the intervention sub-locations that do not sell anti-pyretics or anti-malarials, have been functioning for less than the specified amount of time defined from the baseline retail census, and are not perceived to be well established, respected businesses by the local community
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Anticipated start date
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07/05/2008
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Anticipated end date
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01/06/2010
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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540 homesteads in each group (target: 79 childhood fevers); 153 shops participating
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Interventions
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This is a pre-post randomised cluster controlled design, with clusters (sub-locations) randomly allocated to 9 intervention and 9 control groups. We will need to collect data on 540 homesteads in the intervention and control groups to be able to target a sample size of 79 childhood fevers per group. Shops participating in the survey: 153 in each group.
The intervention will consist of the following components:
1. Subsidised, pre-packaged artemether-lumefantrine sold in selected retail outlets in two doses:
1.1. Tablets for 5 kg to less than 15 kg: treatment dose of 20/120 mg once daily
1.2. Tablets for 15 kg to less than 25 kg: treatment dose of 40/240 mg once daily
2. Shopkeepers will be trained on malaria symptoms, clinical diagnosis, treatment and referral of children under the age of five
3. Community promotional/educational activities will be targeted at caregivers of children under five years on malaria symptoms, clinical diagnosis, treatment options and when to seek treatment from a health facility
Total duration of the intervention: one year and six months
Follow-up duration in both arms: after 9 months of the intervention, follow-up household and provider surveys will take place in both arms, over a three-month period
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Primary outcome measure(s)
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To determine the impact on the proportion of children under five with fever being treated promptly with appropriate anti-malarial treatment, and adhering to the correct dose.
Timepoints for both primary and secondary outcomes:
At baseline, through household and provider surveys conducted over a four month period prior to the intervention. At follow-up, through household and provider surveys conducted over a three month period, nine to twelve months after the start of the intervention.
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Secondary outcome measure(s)
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1. To determine if private sector retailers can deliver AL to appropriate standards of quality for the treatment of fever in children under five years (provision)
2. To determine distribution of benefits of retail sector delivery of AL by socio-economic status (equitable coverage)
3. To explore reasons for the impact observed and identify any challenges in the implementation process
Timepoints for both primary and secondary outcomes:
At baseline, through household and provider surveys conducted over a four month period prior to the intervention. At follow-up, through household and provider surveys conducted over a three month period, nine to twelve months after the start of the intervention.
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Sources of funding
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1. The Wellcome Trust (UK) (grant ref: 077092)
2. Department for International Development (DFID) (UK)
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Trial website
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Publications
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Contact name
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Miss
Beth
Kangwana
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Address
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KEMRI Wellcome Trust Research Programme
PO BOX 43640
00100 GPO
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City/town
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Nairobi
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Zip/Postcode
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-
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Country
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Kenya
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Sponsor
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Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme (Kenya)
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Address
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PO Box 43640
00100 GPO
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City/town
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Nairobi
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Zip/Postcode
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-
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Country
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Kenya
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Tel
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+254 (0)20 2720163
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Fax
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+254 (0)20 2711673
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Email
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info@nairobi.kemri-wellcome.org
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Sponsor website:
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http://www.kemri-wellcome.org
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Date applied
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23/04/2008
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Last edited
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27/06/2008
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Date ISRCTN assigned
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25/04/2008
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