CysticercosisEFECABNCT03095339
EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso
A study testing Educational package in people with Cysticercosis, run by University of Oklahoma at 1 site in Burkina Faso.
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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cysticercosis
- What is being tested?
- Educational package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 21 Feb 2011to 31 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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:
- Presence of confirmed epilepsy or progressively worsening severe chronic headaches at baseline.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cysticercosis
- Being tested
- Educational package
- Keywords
- Burkina Faso, Community-based randomized controlled trial, Cysticercosis, Implementation Research, Effectiveness
- Medical subject headings
- Cysticercosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational package |
| Control | No intervention | The control group did not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human active cysticercosis cumulative incidence
Sero conversion to the AgELISA test to detect antigens of cysticercosis
Measured: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
Secondary outcomes (4)
Porcine active cysticercosis prevalence
Sero-positivity to the AgELISA test to detect antigens of cysticercosis
Measured: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
Change in knowledge, attitude and practices
Change in answers to the questionnaire through time
Measured: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
Cumulative incidence of epilepsy and progressively worsening severe chronic headaches
development of neurological disorders among those followed up at least twice
Measured: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
Stigmatization of epilepsy
Attitudes and knowledge regarding epilepsy post randomization
Measured: 18 months follow-up post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start21 Feb 2011
- Primary completion24 Nov 2014
- Study completion31 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CysticercosisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pre-post community-based randomized controlled trial. The unit of randomization is the village (community)
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Hélène Carabin, DVM PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095339
- Sponsor's protocol ID
- 1419
- Acronym
- EFECAB
- Status last verified
- Mar 2018
- First submitted
- 22 Mar 2017
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available at the time of publication as per NIH requirements
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 25544938Nitiema 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 22289127John 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 26580325Carabin 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 26588468Dermauw 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 27884445Carabin 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 28426664Ngowi 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 28569208Sahlu 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 at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso
- ClinicalTrials.gov ID
- NCT03095339
- Acronym / sponsor ID
- EFECAB / 1419
- Conditions
- Cysticercosis
- Keywords
- Burkina Faso, Community-based randomized controlled trial, Cysticercosis, Implementation Research, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- 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
- Study start
- 21 Feb 2011 (actual)
- Primary completion
- 24 Nov 2014 (actual)
- Study completion
- 31 Jan 2015 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pre-post community-based randomized controlled trial. The unit of randomization is the village (community)
| Arm | Type | Receives |
|---|---|---|
| Educational package | Active comparator | Other: Educational packageThe 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. |
| Control | No intervention | –The control group did not receive any intervention |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Aged 5 years old or more
- Has lived in the village for at least 12 months
Key exclusion criteria (6 listed)
- 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
- Presence of confirmed epilepsy or progressively worsening severe chronic headaches at baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational packageThe 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. | Other | Educational package |
Primary outcome
Human active cysticercosis cumulative incidence
Time frame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
Sero conversion to the AgELISA test to detect antigens of cysticercosis
4 secondary outcomes
Porcine active cysticercosis prevalence
Time frame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
Change in knowledge, attitude and practices
Time frame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
Cumulative incidence of epilepsy and progressively worsening severe chronic headaches
Time frame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization
Stigmatization of epilepsy
Time frame: 18 months follow-up post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Background: PubMed 25544938Carabin 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.
- Background: PubMed 22289127Nitiema 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.
- Background: PubMed 26580325John 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.
- Background: PubMed 26588468Carabin 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.
- Background: PubMed 27884445Dermauw 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.
- Background: PubMed 28426664Carabin 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 publication: PubMed 28569208Ngowi 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.
- Derived from this study: PubMed 30653519Sahlu 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.
- Website of the facility in Burkina Faso which managed the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be made available at the time of publication as per NIH requirements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène Carabin, DVM PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational package in people with Cysticercosis, run by University of Oklahoma at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human active cysticercosis cumulative incidence (time frame: baseline, 18 months follow-up pre randomization, 18 months follow-up post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03095339, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.