EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso

Study Overview
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Brief Summary
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This is a pre-post randomized community-based controlled trial aimed at estimating the effectiveness of an educational package developed using PRECEDE PROCEED to reduce the cumulative incidence of Taenia solium cysticercosis in three Provinces of Burkina Faso. The study design included an 18-months baseline study to measure baseline cumulative incidence of cysticercosis followed by an 18-month post randomization study to measure the effectiveness of the intervention. Sixty villages of three Provinces of Burkina Faso were included. The primary outcome was the change in the baseline to post randomization cumulative incidence in the intervention group compared to the control group.

Official Title
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EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso

Conditions
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Cysticercosis

Intervention / Treatment
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* Other: Educational package


Participation Criteria
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Eligibility Criteria
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The unit of randomization and analysis of this study is the village. Therefore, the eligibility criteria were determined at the village level. Inclusion Criteria: Population of at least 1000 at the 2006 census Present on the map of the Institut Géographique du Burkina 2000 Separated from another village by at least 5 kilometers. Exclusion Criteria: Village located on a National or Provincial road Village located within 20 km of Koudougou or Ouagadougou Regional or Provincial Capital Absence of pigs in the village At the individual level, the following eligibility criteria were used: Inclusion Criteria: Aged 5 years old or more Has lived in the village for at least 12 months Not planning to move in the next three years Exclusion Criteria: Presence of confirmed epilepsy or progressively worsening severe chronic headaches at baseline.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a pre-post community-based randomized controlled trial. The unit of randomization is the village (community)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Educational package<br>The educational package included the offering of the Self-Esteem , Associative strengths, Resourcefulness, Action-planning and Responsibility (SARAR) Participatory Hygiene and Sanitation Transformation (PHAST) approach, a 52 minutes educational movie and accompanying cartoon booklet. The package was developed using the PRECEDE approach. | Other: Educational package<br>* The educational package was offered to 30 villages post randomization. The field team completed the SARAR PHAST with community members for 2-3 days in each intervention village. The movie was projected every night for 2-3 days in each intervention village.<br>|
| No Intervention: Control<br>The control group did not receive any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human active cysticercosis cumulative incidence | Sero conversion to the AgELISA test to detect antigens of cysticercosis | baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Porcine active cysticercosis prevalence | Sero-positivity to the AgELISA test to detect antigens of cysticercosis | baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization | 
| Change in knowledge, attitude and practices | Change in answers to the questionnaire through time | baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization | 
| Cumulative incidence of epilepsy and progressively worsening severe chronic headaches | development of neurological disorders among those followed up at least twice | baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization | 
| Stigmatization of epilepsy | Attitudes and knowledge regarding epilepsy post randomization | 18 months follow-up post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burkina Faso, Community-based randomized controlled trial, Cysticercosis, Implementation Research, Effectiveness