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 |
| Secondary identifying numbers | 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
Scientific
Centre de Recherche en Santé de Nouna
BP 02
Nouna
-
Burkina Faso
| bocar.crsn@fasonet.bf |
Study information
| 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 |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 | 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 study start date | 01/09/2002 |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | Burkina Faso N = 2089, Tanzania N = 1715 (at baseline) |
| 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
-
Burkina Faso
Sponsor information
Research Centre in Health of Nouna (Centre de Recherche en Santé de Nouna [CRSN]) (Burkina Faso)
Research organisation
Research organisation
BP 02
Nouna
-
Burkina Faso
"ROR" |
https://ror.org/059vhx348 |
|---|
Funders
Funder type
Government
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
