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CompletedNCT03095339EFECABUpdated Apr 3, 2018

EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso

An interventional study of Educational package in Cysticercosis, sponsored by University of Oklahoma. Completed at 1 site in Burkina Faso. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-03.

Sponsored by University of Oklahoma · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
5 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cysticercosis

Keywords

  • Burkina Faso
  • Community-based randomized controlled trial
  • Cysticercosis
  • Implementation Research
  • Effectiveness
03

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • 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

  • No intervention
    Control

    The control group did not receive any intervention

Interventions

  • OtherEducational 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.

05

What researchers measure

Primary outcomes

  1. Human active cysticercosis cumulative incidence

    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 outcomes

  1. Porcine active cysticercosis prevalence

    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

  2. Change in knowledge, attitude and practices

    Change in answers to the questionnaire through time

    Time frame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization

  3. Cumulative incidence of epilepsy and progressively worsening severe chronic headaches

    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

  4. Stigmatization of epilepsy

    Attitudes and knowledge regarding epilepsy post randomization

    Time frame: 18 months follow-up post randomization

06

Study locations

1 site
  • AFRICSanté
    Bobo Dioulasso, Burkina Faso
07

References and documents

Publications

  • 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. PubMed 25544938 ↗
  • 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. PubMed 22289127 ↗
  • 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. PubMed 26580325 ↗
  • 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. PubMed 26588468 ↗
  • 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. PubMed 27884445 ↗
  • 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. PubMed 28426664 ↗
  • 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. PubMed 28569208 ↗
  • 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. PubMed 30653519 ↗

Study documents

  • Study protocol · Oct 12, 2014

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified data will be made available at the time of publication as per NIH requirements

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Registry details

Key details

Study ID
NCT03095339
Lead 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
Responsible party
Sponsor
First posted
Mar 29, 2017
Start date
Feb 21, 2011
Primary completion
Nov 24, 2014
Completion
Jan 31, 2015
Last update
Apr 3, 2018

Study contacts

Hélène Carabin, DVM PhD
principal investigator · University of Oklahoma

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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