Contact information
Type
Scientific
Primary contact
Dr Bocar Kouyaté
ORCID ID
Contact details
Centre de Recherche en Santé de Nouna
BP 02
Nouna
-
Burkina Faso
bocar.crsn@fasonet.bf
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICA4-CT-2001-10010
Study information
Scientific title
Acronym
MAMOP
Study hypothesis
This trial will be taking place in Burkina Faso and Tanzania, with slightly different interventions taking place in each area. The differences will be noted under the relevant sections with the title of the country in which the changes are taking place.
Tanzania:
To evaluate the feasibility and effectiveness of an intervention aimed at improving case management of malaria in under-five children through the primary caretakers in collaboration with local women groups and existing health centres.
Burkina Faso:
The study hypothesis is that improved home management of malaria in young children of Sub-Saharan Africa (SSA) will result in earlier treatment with consequently reduced morbidity and mortality.
Ethics approval
The study was approved by:
1. The local Ethics Committee in Burkina Faso
2. The Tanzanian Commission of Science and Technology
Study design
Multicentre, interventional, cluster-randomised, controlled, community intervention effectiveness trial with a pre-post design.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Treatment of childhood febrile illness; malaria
Intervention
Tanzania (trial ran from 01/02/2004 to 01/05/2005):
Study children N = 1715 children in baseline, 2169 in follow-up (aim was to enrol one under five from each of a minimum of 1200 households). Health workers were trained to train local women leaders in recognising malaria symptoms, providing first line treatment for uncomplicated malaria (sulfadoxine/pyrimethamine) and referring severe cases. The health workers were also trained to supervise the women groups. The evaluation was through a baseline survey on children aged 6 to 59 months in early 2004 and a follow-up survey in early 2005, i.e. the follow-up was after 10 months.
Burkina Faso (trial ran from 01/09/2002 to 31/10/2004):
Study children N = 2089 (1200 households). The intervention consisted of training of health workers on malaria home treatment, of training of women group leaders on malaria home treatment, of treatment of under five children through their mothers supervised by women group leaders, of supervision of women group leaders by health workers, and of provision of malaria drugs through health workers in form of a revolving fund. Follow up in Burkina Faso was for the two rainy seasons.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary outcome of the study was the proportion of moderate to severe anaemia (haematocrit less than 24%, haemoglobin less than 8 g/L) in children aged six to 59 months.
Evaluation of the trial in Burkina Faso was through a baseline and a follow-up survey.
In the Tanzanian study: Baseline survey Feb-April 2004 and follow-up survey Feb-April 2005.
Secondary outcome measures
1. Fever and malaria prevalence
2. Prevalence of palpable spleens (Hackett score greater than two)
3. Prevalence of other illnesses
4. Mean species-specific number of blood films positive for malaria parasites
5. Mean species-specific malaria parasite densities
6. Mean haematocrit and haemoglobin values
7. Mean weight
8. In vivo chloroquine resistance
Evaluation of the trial in Burkina Faso was through a baseline and a follow-up survey.
In the Tanzanian study: Baseline survey Feb-April 2004 and follow-up survey Feb-April 2005. The number of particants in the follow up survey was 2169.
Overall trial start date
01/09/2002
Overall trial end date
01/05/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Health workers: all health workers in the district were selected for training
2. Women leaders: all women from the existing women groups in the area were targeted and enrolled if:
2.1. They had completed primary school
2.2. They were a member of an already existing womens group
2.3. They were a resident of the chosen village and expected to live there during the MAMOP study period
This gave 36 women of which 25 were randomly selected for the intervention
3. Households: all households in the randomly sampled villages were included
4. Children: children aged six to 59 months
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Burkina Faso N = 2089, Tanzania N = 1715 (at baseline)
Participant exclusion criteria
1. Women leaders who were:
1.1. Illiterate
1.2. Not resident in the MAMOP villages
2. For all: those who did not consent to participating
3. Children: aged less than six months or greater than 59 months
Recruitment start date
01/09/2002
Recruitment end date
01/05/2005
Locations
Countries of recruitment
Burkina Faso, Tanzania
Trial participating centre
Centre de Recherche en Santé de Nouna
Nouna
-
Burkina Faso
Funders
Funder type
Government
Funder name
European Commission (Belgium) - FP5 (Fifth Framework Programme for Research and Technological Development, Quality of Life and Management of Living Resources Programme) (ref: ICA4-CT-2001-10010)
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
Results - basic reporting
Publication summary
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17207148
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21416034
Publication citations
-
Results
Eriksen J, Tomson G, Mujinja P, Warsame MY, Jahn A, Gustafsson LL, Assessing health worker performance in malaria case management of underfives at health facilities in a rural Tanzanian district., Trop. Med. Int. Health, 2007, 12, 1, 52-61, doi: 10.1111/j.1365-3156.2006.01753.x.
-
Results
Eriksen J, Mujinja P, Warsame M, Nsimba S, Kouyaté B, Gustafsson LL, Jahn A, Müller O, Sauerborn R, Tomson G, Effectiveness of a community intervention on malaria in rural Tanzania - a randomised controlled trial., Afr Health Sci, 2010, 10, 4, 332-340.