NCT03095339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

3.8 years

First QC Date

March 22, 2017

Last Update Submit

March 30, 2018

Conditions

Cysticercosis

Keywords

Burkina FasoCommunity-based randomized controlled trialCysticercosisImplementation ResearchEffectiveness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Porcine active cysticercosis prevalence

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

  • Change in knowledge, attitude and practices

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

  • Cumulative incidence of epilepsy and progressively worsening severe chronic headaches

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

  • Stigmatization of epilepsy

    18 months follow-up post randomization

Study Arms (2)

Educational package

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

The control group did not receive any intervention

Interventions

Educational packageOTHER

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.

Educational package

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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
  • Presence of confirmed epilepsy or progressively worsening severe chronic headaches at baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AFRICSanté

Bobo-Dioulasso, Burkina Faso

Location

Related Publications (8)

  • 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.

    PMID: 25544938BACKGROUND

  • 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.

    PMID: 22289127BACKGROUND

  • 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.

    PMID: 26580325BACKGROUND

  • 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.

    PMID: 26588468BACKGROUND

  • 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.

    PMID: 27884445BACKGROUND

  • 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.

    PMID: 28426664BACKGROUND

  • 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.

    PMID: 28569208RESULT

  • 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.

    PMID: 30653519DERIVED

Related Links

MeSH Terms

Conditions

Cysticercosis

Condition Hierarchy (Ancestors)

TaeniasisCestode InfectionsHelminthiasisParasitic DiseasesInfections

Study Officials

  • Hélène Carabin, DVM PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a pre-post community-based randomized controlled trial. The unit of randomization is the village (community)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2017

First Posted

March 29, 2017

Study Start

February 21, 2011

Primary Completion

November 24, 2014

Study Completion

January 31, 2015

Last Updated

April 3, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

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

Locations

BU(1)