Condition category
Infections and Infestations
Date applied
02/04/2007
Date assigned
31/05/2007
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Research Centre in Health of Nouna (Centre de Recherche en Santé de Nouna [CRSN]) (Burkina Faso)

Sponsor details

BP 02
Nouna
-
Burkina Faso

Sponsor type

Research organisation

Website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes