Improving the management of childhood MAlaria: an experiment to bridge the gap between MOthers and health care Providers

ISRCTN	ISRCTN34104704
DOI	https://doi.org/10.1186/ISRCTN34104704
Protocol serial number	ICA4-CT-2001-10010
Sponsor	Research Centre in Health of Nouna (Centre de Recherche en Santé de Nouna [CRSN]) (Burkina Faso)
Funder	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)

Submission date: 02/04/2007
Registration date: 31/05/2007
Last edited: 16/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Bocar Kouyaté
Scientific

Centre de Recherche en Santé de Nouna
BP 02
Nouna
-
Burkina Faso

Email	bocar.crsn@fasonet.bf

Study information

Primary study design	Interventional
Study design	Multicentre, interventional, cluster-randomised, controlled, community intervention effectiveness trial with a pre-post design.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MAMOP
Study objectives	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(s)	The study was approved by: 1. The local Ethics Committee in Burkina Faso 2. The Tanzanian Commission of Science and Technology
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/05/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	59 Months
Sex	All
Target sample size at registration	2089
Key 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
Key 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
Date of first enrolment	01/09/2002
Date of final enrolment	01/05/2005

Locations

Countries of recruitment

Burkina Faso
Tanzania

Study participating centre

Centre de Recherche en Santé de Nouna

Nouna
-
Burkina Faso

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2007		Yes	No
Results article	results	01/12/2010		Yes	No