Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SSC 1361
Study information
Scientific title
The impact of retail sector delivery of artemether-lumefantrine on effective malaria treatment of children under five in Kenya
Acronym
Study hypothesis
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.
As of 27/01/2009 this record was updated. All updates can be found in the relevant section under the above update date. Please note that as this time the target number of participants was updated from '540 homesteads in each group (target: 79 childhood fevers); 153 shops participating' to the below information. Please also note that the anticipated start date mentioned below is for the start of the evaluation; the anticipated start date for the interventions recruitment was 29/09/2008.
Ethics approval
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)
3. Pharmacy and Poisons Board (PPB), Ethical Committee for Clinical Trials (ECCT) received on 12th August 2008 for the duration of a year (ref: PPB/ECCT/08/07)
Special dispensation was granted from the Pharmacy and Poisons Board (Kenya) allowing artemether-lumefantrine to be temporarily deregulated to an over-the-counter medication in the intervention sub locations solely for the purposes of the study.
Study design
Interventional, pre-post randomised cluster controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Malaria
Intervention
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 1,161 homesteads in the intervention and control groups to be able to target a sample size of 79 childhood fevers per group. Potential number of shops participating in the survey: 225 in the intervention arm.
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 twice daily for 3 days
1.2. Tablets for 15 kg to less than 25 kg: treatment dose of 40/240 mg twice daily for 3 days 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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Artemether-lumefantrine
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
07/05/2008
Overall trial end date
01/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Added as of 27/01/2009:
Please note that the specified minimum amount of time for which the selected retail outlets should have been functioning has been identified as a minimum period of six months prior to the baseline survey.
Initial information at time of registration:
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)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1,161 homesteads in each group (target: 79 childhood fevers); 225 shops were identified as potential participants
Participant exclusion criteria
Added as of 27/01/2009:
Please note that the specified minimum amount of time for which the selected retail outlets should have been functioning has been identified as a minimum period of six months prior to the baseline survey.
Current information as of 16/04/2010:
1. Children less than 3 months. These children will be referred directly to a health facility.
2. Children 3 - 59 months, suffering from Integrated Management of Childhood Illness (IMCI) danger signs. These children will be referred directly to a health facility.
3. 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
Initial information at time of registration:
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
Recruitment start date
07/05/2008
Recruitment end date
01/06/2010
Locations
Countries of recruitment
Kenya
Trial participating centre
KEMRI Wellcome Trust Research Programme
Nairobi
-
Kenya
Sponsor information
Organisation
Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme (Kenya)
Sponsor details
PO Box 43640
00100 GPO
Nairobi
-
Kenya
+254 (0)20 2720163
info@nairobi.kemri-wellcome.org
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 077092)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Department for International Development (DFID) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21655317
Publication citations
-
Results
Kangwana BP, Kedenge SV, Noor AM, Alegana VA, Nyandigisi AJ, Pandit J, Fegan GW, Todd JE, Brooker S, Snow RW, Goodman CA, 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., 2011, 8, 5, e1000437, doi: 10.1371/journal.pmed.1000437.