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Completed

NCT Number: NCT03095339

EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso

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.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AFRICSanté

Bobo-Dioulasso, Burkina Faso

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational package

Other

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.

Primary outcomes

  1. Human active cysticercosis cumulative incidence

    Time frame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization

    Sero conversion to the AgELISA test to detect antigens of cysticercosis

Secondary outcomes

  1. Porcine active cysticercosis prevalence

    Time frame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization

    Sero-positivity to the AgELISA test to detect antigens of cysticercosis

  2. Change in knowledge, attitude and practices

    Time frame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization

    Change in answers to the questionnaire through time

  3. Cumulative incidence of epilepsy and progressively worsening severe chronic headaches

    Time frame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization

    development of neurological disorders among those followed up at least twice

  4. Stigmatization of epilepsy

    Time frame: 18 months follow-up post randomization

    Attitudes and knowledge regarding epilepsy post randomization

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • AFRICSanté
  • Brown University
  • Centre Universitaire Souro Sanou
  • Institut de Recherche en Sciences de la Sante, Burkina Faso
  • Institute of Tropical Medicine, Belgium
  • Technical University of Munich
  • University Hospital, Limoges
  • University of Ouagadougou, Burkina Faso

Registry information

Acronym: EFECAB

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Mar 29, 2017
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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