Clinical trial NCT03095339: EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso
Official title: EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cysticercosis
Keywords: Burkina Faso
Community-based randomized controlled trial
Cysticercosis
Implementation Research
Effectiveness
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: AFRICSanté
name: Institute of Tropical Medicine, Belgium
name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: University of Ouagadougou, Burkina Faso
name: University Hospital, Limoges
name: Centre Universitaire Souro Sanou
name: Technical University of Munich
name: Brown University
First posted: 2017-03-29
Enrollment: 58
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pre-post community-based randomized controlled trial. The unit of randomization is the village (community)
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Human active cysticercosis cumulative incidence
timeFrame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
Secondary outcomes:
measure: Porcine active cysticercosis prevalence
timeFrame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
measure: Change in knowledge, attitude and practices
timeFrame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
measure: Cumulative incidence of epilepsy and progressively worsening severe chronic headaches
timeFrame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
measure: Stigmatization of epilepsy
timeFrame: 18 months follow-up post randomization
Other outcomes:
Locations:
city: Bobo Dioulasso
country: Burkina Faso
facility: AFRICSanté
Study officials:
affiliation: University of Oklahoma
name: Hélène Carabin, DVM PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.