EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso (EFECAB)

March 30, 2018 updated by: University of Oklahoma
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Educational package
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
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.
No Intervention: Control
The control group did not receive any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
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
baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
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
baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
Stigmatization of epilepsy
Time Frame: 18 months follow-up post randomization
Attitudes and knowledge regarding epilepsy post randomization
18 months follow-up post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

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

Investigators

  • Principal Investigator: Hélène Carabin, DVM PhD, University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2011

Primary Completion (Actual)

November 24, 2014

Study Completion (Actual)

January 31, 2015

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

April 3, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1419

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified data will be made available at the time of publication as per NIH requirements

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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