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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01517230
Other study ID # 2011-9-56
Secondary ID 6028
Status Completed
Phase N/A
First received January 9, 2012
Last updated May 19, 2015
Start date March 2012
Est. completion date April 2015

Study information

Verified date May 2015
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics CommitteeBurkina Faso: Ministry of Health
Study type Interventional

Clinical Trial Summary

A cluster-randomised trial will be undertaken in Burkina Faso to investigate whether a comprehensive mass media campaign using local radio stations can change behaviours on a scale large enough to result in measurable and sustainable reductions in under-five child mortality.

It is hypothesised that as a result of the scale and multi-pronged nature of the campaign, reductions of between 10% and 20% in child mortality will be achieved.


Description:

The evaluation is conducted in 14 geographical locations throughout Burkina Faso. Seven of these 14 clusters have been randomly allocated to receive the mass media intervention while the remaining 7 clusters will serve as controls.

Data collection includes household surveys in all 14 clusters at three "key" times:

- At baseline: Before the implementation of the intervention, between December 2011 and February 2012 to measure the current level of child mortality and evaluate current knowledge and behaviours of relevance to child health.

- At midline: Fifteen months after implementation of the intervention to evaluate the coverage of the intervention (in the intervention clusters) and, in each cluster, knowledge and behaviours.

- At endline: Two and a half years after implementation of the intervention to evaluate intervention coverage (in the intervention clusters), knowledge and behaviours and child mortality.


Recruitment information / eligibility

Status Completed
Enrollment 100000
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 5 Years
Eligibility Inclusion Criteria:

- Residence in study clusters

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

Behavioral:
Local radio campaign to reduce under-five child mortality
The media campaign is designed by Development Media International. It includes short "spots" and long format programs broadcast by rural community radios. Major topics to be addressed include: diarrhoea, water and sanitation, acute respiratory infections, fever/malaria, antenatal consultations, delivery in health facilities, breastfeeding, and child nutrition. The intervention is planned to start in March 2012 after completion of fieldwork for the baseline survey and will continue for 2.5 years.

Locations

Country Name City State
Burkina Faso Centre Muraz Bobo-Dioulasso

Sponsors (5)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine Centre Muraz, Development Media International, Planet Wheeler Foundation, Wellcome Trust

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post neonatal under-five all cause mortality 1 year No
Secondary Under-5 child all cause mortality 1year No
Secondary Preventive behaviours for main causes of under-five children mortality Antenatal consultations during the last pregnancy which lasts more than 6 months and place of delivery
Breastfeeding practices for the youngest under-five child
Behaviours to prevent cases of diarrhoea and malaria in the youngest under-five child
1 year No
Secondary Knowledge Knowledge about danger signs during pregnancy, delivery and in young ill children
Knowledge about preventive measure against malaria during pregnancy
Knowledge about recommended breastfeeding behaviours
Knowledge about transmission of malaria and diarrhoea
Knowledge about health care seeking behaviours in young children suffering from diarrhoea, bad cough
30-36 months after the start of the intervention No
Secondary Cost-effectiveness of mass media campaigns in terms of dollars per disability-adjusted life year (DALY) averted 1 year No
Secondary Curative behaviours for main causes of under-five children mortality Health care behaviours to treat cases of diarrhoea, fever, cough and respiratory difficulties in the youngest under-five child during the 15 previous days 15 days No
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