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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oklahoma

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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Dietary Supplements

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Locations

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