EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso

Cysticercosis Clinical Trial

— EFECAB  

Official title:

EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095339
• Other study ID #: 1419
• Status: Completed
• Phase: N/A
• First received: March 22, 2017
• Last updated: March 30, 2018
• Start date: February 21, 2011
• Est. completion date: January 31, 2015

Study information

• Verified date: March 2018
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 31, 2015
• Est. primary completion date: November 24, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cysticercosis
• Epilepsy
• Neurocysticercosis

Intervention

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.

Locations

Country	Name	City	State
Burkina Faso	AFRICSanté	Bobo Dioulasso

Sponsors (9)

Lead Sponsor	Collaborator
University of Oklahoma	AFRICSanté, Brown University, Centre Universitaire Souro Sanou, Institut de Recherche en Sciences de la Sante, Burkina Faso, Institute of Tropical Medicine, Belgium, Technische Universität München, University Hospital, Limoges, University of Ouagadougou, Burkina Faso

Country where clinical trial is conducted

Burkina Faso, 

References & Publications (7)

Carabin H, Millogo A, Cissé A, Gabriël 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. — View Citation

Carabin H, Traoré AA. Taenia solium taeniasis and cysticercosis control and elimination through community-based interventions. Curr Trop Med Rep. 2014 Dec 1;1(4):181-193. — View 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. — View Citation

Dermauw V, Ganaba R, Cissé A, Ouedraogo B, Millogo A, Tarnagda Z, Van Hul A, Gabriël 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. — View 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. Review. — View Citation

Ngowi H, Ozbolt I, Millogo A, Dermauw V, Somé 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 Burkin — View Citation

Nitiéma P, Carabin H, Hounton S, Praet N, Cowan LD, Ganaba R, Kompaoré C, Tarnagda Z, Dorny P, Millogo A, Efécab. 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Stigmatization of epilepsy	Attitudes and knowledge regarding epilepsy post randomization	18 months follow-up post randomization

External Links

•   Website of the facility in Burkina Faso which managed the study