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

Primary Purpose

Cysticercosis

Status

Completed

Phase

Not Applicable

Locations

Burkina Faso

Study Type

Interventional

Intervention

Educational package

About this trial

This is an interventional prevention trial for Cysticercosis focused on measuring Burkina Faso, Community-based randomized controlled trial, Cysticercosis, Implementation Research, Effectiveness

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

AFRICSanté

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Educational package

Control

Arm Description

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.

The control group did not receive any intervention

Outcomes

Primary Outcome Measures

Human active cysticercosis cumulative incidence

Sero conversion to the AgELISA test to detect antigens of cysticercosis

Secondary Outcome Measures

Porcine active cysticercosis prevalence

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

Change in knowledge, attitude and practices

Change in answers to the questionnaire through time

Cumulative incidence of epilepsy and progressively worsening severe chronic headaches

development of neurological disorders among those followed up at least twice

Stigmatization of epilepsy

Attitudes and knowledge regarding epilepsy post randomization

Full Information

NCT ID

NCT03095339

First Posted

March 22, 2017

Last Updated

March 30, 2018

Sponsor

University of Oklahoma

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03095339

Brief Title

EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso

Acronym

EFECAB

Official Title

EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

February 21, 2011 (Actual)

Primary Completion Date

November 24, 2014 (Actual)

Study Completion Date

January 31, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oklahoma

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cysticercosis

Keywords

Burkina Faso, Community-based randomized controlled trial, Cysticercosis, Implementation Research, Effectiveness

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a pre-post community-based randomized controlled trial. The unit of randomization is the village (community)

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Educational package

Arm Type

Active Comparator

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

The control group did not receive any intervention

Intervention Type

Other

Intervention Name(s)

Educational package

Intervention Description

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 Outcome Measure Information:

Title

Human active cysticercosis cumulative incidence

Description

Sero conversion to the AgELISA test to detect antigens of cysticercosis

Time Frame

baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization

Secondary Outcome Measure Information:

Title

Porcine active cysticercosis prevalence

Description

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

Time Frame

baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization

Title

Change in knowledge, attitude and practices

Description

Change in answers to the questionnaire through time

Time Frame

baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization

Title

Cumulative incidence of epilepsy and progressively worsening severe chronic headaches

Description

development of neurological disorders among those followed up at least twice

Time Frame

baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization

Title

Stigmatization of epilepsy

Description

Attitudes and knowledge regarding epilepsy post randomization

Time Frame

18 months follow-up post randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hélène Carabin, DVM PhD

Organizational Affiliation

University of Oklahoma

Official's Role

Principal Investigator

Facility Information:

Facility Name

AFRICSanté

City

Bobo Dioulasso

Country

Burkina Faso

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

25544938

Citation

Carabin H, Traore AA. Taenia solium taeniasis and cysticercosis control and elimination through community-based interventions. Curr Trop Med Rep. 2014 Dec 1;1(4):181-193. doi: 10.1007/s40475-014-0029-4.

Results Reference

background

PubMed Identifier

22289127

Citation

Nitiema P, Carabin H, Hounton S, Praet N, Cowan LD, Ganaba R, Kompaore C, Tarnagda Z, Dorny P, Millogo A, Efecab. Prevalence case-control study of epilepsy in three Burkina Faso villages. Acta Neurol Scand. 2012 Oct;126(4):270-8. doi: 10.1111/j.1600-0404.2011.01639.x. Epub 2012 Jan 31.

Results Reference

background

PubMed Identifier

26580325

Citation

John CC, Carabin H, Montano SM, Bangirana P, Zunt JR, Peterson PK. Global research priorities for infections that affect the nervous system. Nature. 2015 Nov 19;527(7578):S178-86. doi: 10.1038/nature16033.

Results Reference

background

PubMed Identifier

26588468

Citation

Carabin H, Millogo A, Cisse A, Gabriel S, Sahlu I, Dorny P, Bauer C, Tarnagda Z, Cowan LD, Ganaba R. Prevalence of and Factors Associated with Human Cysticercosis in 60 Villages in Three Provinces of Burkina Faso. PLoS Negl Trop Dis. 2015 Nov 20;9(11):e0004248. doi: 10.1371/journal.pntd.0004248. eCollection 2015 Nov.

Results Reference

background

PubMed Identifier

27884445

Citation

Dermauw V, Ganaba R, Cisse A, Ouedraogo B, Millogo A, Tarnagda Z, Van Hul A, Gabriel S, Carabin H, Dorny P. Taenia hydatigena in pigs in Burkina Faso: A cross-sectional abattoir study. Vet Parasitol. 2016 Oct 30;230:9-13. doi: 10.1016/j.vetpar.2016.10.022. Epub 2016 Oct 24.

Results Reference

background

PubMed Identifier

28426664

Citation

Carabin H, Winkler AS, Dorny P. Taenia solium cysticercosis and taeniosis: Achievements from the past 10 years and the way forward. PLoS Negl Trop Dis. 2017 Apr 20;11(4):e0005478. doi: 10.1371/journal.pntd.0005478. eCollection 2017 Apr. No abstract available.

Results Reference

background

PubMed Identifier

28569208

Citation

Ngowi H, Ozbolt I, Millogo A, Dermauw V, Some T, Spicer P, Jervis LL, Ganaba R, Gabriel S, Dorny P, Carabin H. Development of a health education intervention strategy using an implementation research method to control taeniasis and cysticercosis in Burkina Faso. Infect Dis Poverty. 2017 Jun 1;6(1):95. doi: 10.1186/s40249-017-0308-0.

Results Reference

result

PubMed Identifier

30653519

Citation

Sahlu I, Bauer C, Ganaba R, Preux PM, Cowan LD, Dorny P, Millogo A, Carabin H. The impact of imperfect screening tools on measuring the prevalence of epilepsy and headaches in Burkina Faso. PLoS Negl Trop Dis. 2019 Jan 17;13(1):e0007109. doi: 10.1371/journal.pntd.0007109. eCollection 2019 Jan.

Results Reference

derived

Links:

URL

http://africsante.org/

Description

Website of the facility in Burkina Faso which managed the study

Learn more about this trial

EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso

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