EFECAB: Improving Pig Management to Prevent Epilepsy in Burkina Faso
Phase: NA
Conditions: Cysticercosis
Sponsor: University of Oklahoma

RESEARCH PROTOCOL OUTLINE 
 
Instructions:  Protocols should be formatted according to the following outline and include all of 
the elements indicated.   
 
 
 
 
Title of Project: EFECAB: Improving pig management to prevent epilepsy in Burkina Faso 
 
Principal Investigator: 
Hélène Carabin; D.V.M. Ph.D.; Dept of Biostatistics & Epidemiology 
Co-Investigators: 
 
Athanase Millogo, M.D., University of Ouagadougou, Burkina Faso 
Rasmané Ganaba, D.V.M., Ph.D., AFRICSanté, Burkina Faso 
Zékiba Taganda, D.V.M., Ph.D., IRSS, Burkina Faso 
Jean-Bosco Ouédraogo, M.D, Ph.D., Centre MURAZ, Burkina Faso 
Pierre Dorny D.V.M., Ph.D., ITMA, Belgium 
 
Abstract 
This proposal extends the work of our pilot project, “Epidemiology and Burden of 
Neurocysticercosis in Bukina Faso” (R21 NS055353) which was successfully conducted due to 
the development of strong research collaboration and the dedication of our group to improving 
the living conditions of the Burkinabé people. Our ultimate goal is to develop a sustainable, 
cost-beneficial intervention strategy to reduce the incidence and prevalence of 
neurocysticercosis (NCC) and associated neurological conditions across the lifespan. Inclusion of 
epilepsy and NCC in the list of notifiable diseases for Burkina Faso will be pilot tested as a 
surveillance mechanism. Based on our pilot study findings, we estimate that an educational 
intervention targeting pig farmers could reduce the incidence of infection in humans and pigs 
by one-half. We also estimate that this could result, in the long term, in reducing the incidence 
rate of recurrent seizures in Burkina Faso by 25% in villages where pigs are raised. We will use 
the PRECEDE PROCEED approach to develop educational materials to maximize the monetary 
benefits of farmers through healthy pig raising. A pre-post randomized community trial will be 
conducted in 60 villages located in three provinces, using a 18-month baseline and 18-month 
post-intervention follow-up of 80 participants per village. The effectiveness of the educational 
materials in reducing the incidence rate of human and porcine cysticercosis, and of recurrent 
seizures and severe headaches, will be estimated. If effective, this sustainable intervention 
could be exported to other pig-raising countries in Sub-Saharan Africa to reduce the frequency 
of cysticercosis and epilepsy.  

 
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A. Specific Aims 
The ultimate goal of the proposed project is to develop a sustainable, cost-beneficial and 
cost-effective intervention strategy to reduce the incidence and prevalence of 
neurocysticercosis (NCC) and associated neurological disease across the lifespan. We have 
identified three aims focusing on ongoing research capacity building and five research aims.  
The capacity building aims include: 1) strengthening prior collaborations initiated during the 
R21; 2) establishing the Cysticercosis Working Group for Western and Central Africa (CWGWCA) 
headquarters in Burkina Faso; and 3) developing and testing the inclusion of seizures, epilepsy 
and NCC in the list of notifiable diseases routinely collected by the Health Information System 
managed by the Ministry of Health in Burkina Faso.  
The research aims are to: 1) Use the PRECEDE PROCEED approach to develop a training 
package to educate farmers on cysticercosis and raise awareness of villagers about sanitation; 
2) Estimate the effectiveness of the educational intervention developed in Research Aim 1 in 
reducing the cumulative incidence and prevalence of human cysticercosis through a 
randomized community-based controlled trial; 3) Estimate the effectiveness of the intervention 
in reducing the incidence rate of porcine cysticercosis and in improving fertility in pigs (number 
of piglets per sow and number of litters per sow); 4)  Estimate the 3-year cumulative incidence 
of seroconversion to the antigens of cysticercosis in humans and in pigs, and of neurological 
disorders (epilepsy, acute seizures and severe progressive headaches).  
B.  Background and Significance 
 
NCC results from CNS invasion by the larval stage of T. solium. The type of CNS disease 
produced depends on both the location and evolutionary stage of the cyst (Prabhakar and 
Singh, 2002). Clinical manifestations of parenchymal cysts, the most common location, include 
seizures, severe, progressively worsening headache, and focal neurological deficit, the first two 
being the most common. Seizures occur at some stage in 66-90% of NCC cases. Thus, 
identification of persons with seizures is a logical starting point for identification of persons 
with NCC.  
 
There have been numerous cross-sectional studies conducted on the prevalence of 
cysticercosis in humans and pigs and of NCC in humans, but, to our knowledge, there have been 
only two short reports published on cohort studies of seroconversion with antibodies to T. 
solium. Both studies were conducted in Latin America. No cohort study of human cysticercosis 
and NCC, as measured by the presence of antigens, has ever been conducted. In addition, there 
has never been a cohort study in Africa of cysticercosis infection in humans. There are only two 
controlled studies on the effectiveness of educational interventions to prevent cysticercosis. 
The lifecycle of this organism is well documented and its association with significant 
neurological conditions, such as epilepsy and severe headache, has been established. It is now 
time to test sustainable interventions to control this preventable cause of epilepsy and other 
neurological disorders that significantly affect the lives of people of all ages in areas endemic 
for T. solium, which includes most of Africa. 
C.  Preliminary Studies/Progress Report   
 
The severe underdevelopment in Burkina Faso makes conducting research in this country 
challenging. Nonetheless, a strong research collaboration and belief in the need for improving 
the living conditions of the Burkinabé people made our pilot project a success. A critical 
element of our success was the collaboration of the local population in actively participating in 

 
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the study. In the past three years, we have made excellent progress in building research 
capacity and in demonstrating the feasibility of research in neurological disorders in Burkina 
Faso. We describe below how each of the specific aims of our earlier R21 grant were met.  
 
Our preliminary results indicate a high prevalence of lifetime and “active” epilepsy. In 
addition, 37.2% of those with recurrent seizures who received a CT-scan had lesions suggestive 
of NCC. In villages where pigs are raised, this proportion was between 50% and 55%. We also 
found a high prevalence (11.7%) of blood antigens of the larval stage of T. solium in Batondo. 
The seroprevalence to the larval stages of T. solium was also high in pigs (36% and 45%) in the 
two villages where pigs were raised. Based on these findings, we will target the area 
surrounding Batondo where cysticercosis is most endemic.  
D.  Research Design and Methods 
In the interest of space, we will only describe the research methods in this section.  
D.1 Development and testing of the educational program (Research aims 1-3) 
 
PRECEDE stands for Predisposing, Reinforcing, and Enabling Constructs in Educational 
Diagnosis and Evaluation. We will conduct Focus Group Discussions (FGD) and in-depth 
interviews with pig farmers and villagers from 3 pilot villages located in the 3 provinces 
targeted for the RCT. The questionnaires used by Dr. Ngowi in Tanzania will be adapted to the 
socio-cultural characteristics of Burkina Faso and to add questions on sanitation. Based on the 
PRECEDE model, we will organize the data from the FGD and the questionnaires to identify 
predisposing, reinforcing, and enabling behavioural factors to be targeted for the intervention. 
Final targets for the intervention will be identified during this phase considering resources and 
support available, organizational constraints, and barriers that could influence the intervention 
in the areas. PROCEED is an abbreviation for Policy, Regulatory, and Organizational Constructs 
in Educational and Environmental Development. We will target 2 major audiences: a) the public 
health extension officials and b) the smallholder pig farmers. We will divide the interventions 
into 2 main types: a) the provision of education through the group approach by organizing 
related seminars and training sessions; and b) the dissemination of illustrated and audio-visual 
materials such as leaflets, posters, comic books and the production of a video-tape. The impact 
of our intervention strategy will be assessed by comparing the pre-post randomization 
Knowledge, Attitudes and Practices (KAP) between the intervention and control groups. The 
effectiveness of the intervention will be measured as described later. 
D2. Randomized community trial (Research Aims 2-3) 
 
We will conduct a randomized community-based controlled trial (RCT) to estimate the 
effectiveness of an educational package in reducing the incidence rate of human and porcine 
cysticercosis in 60 villages in 30 of the 31 departments located in the Provinces of Boulkiemdé 
(15 departments) and Sanguié (10 departments) in the Region of Centre-Ouest, and Nayala (6 
departments) in the Region of Boucle du Mouhon. According to the 2006 census, there were 
498,008, 297,230 and 162,869 people in these provinces, respectively. The RCT will be 
conducted over 3 years, including a 1-year baseline follow-up period. The RCT will be followed 
by 2 years of post-intervention follow-up. Pigs are common in those Regions. Boulkiemdé and 
Sanguié are inhabited by the Mossi and Gourounsi ethnic groups, who were involved in our 
pilot project. Nayala, inhabited by Samo people, is 1 of the 3 provinces out of 5 in that region 
where pigs are bred. Traditionally, the method of pig-keeping is different according to the 

 
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region: in the Centre Ouest pigs are not kept in pens whereas in Nayala, pigs are put in pens 
that are also used by household members as toilets.  
 
In each department, we will select two non-neighboring villages and invite the chief to 
consult with the community council to ask for their willingness to participate. The inclusion 
criteria for villages are: 1) the presence of some pig farming, which is probably the case in all 
villages of the 3 provinces, and 2) at least 80 concessions (a collection of households which 
shares a common area) in the village. In each randomly selected village, we will first conduct a 
census of all concessions as was done in the pilot study and randomly sample 80 concessions. A 
similar random sampling method as described for the selection of the concessions will be used 
to randomly select one member of the concession. Both the heads of the households and of the 
concession will be asked for their consent to participate. Based on our pilot experience, we 
expect nearly 100% participation at the concession level. All 80 selected individuals (1 from 
each concession) will be invited to answer a screening questionnaire on seizures and 
headaches. Of those 80, 60 selected at random will be invited to also participate in a serological 
examination for the detection of the larval stages of T. solium, which will involve blood 
sampling. Participants who do not have neurological disorders at baseline will be invited to 
participate in a follow-up study for a period of 3 years. Participants free of neurological 
disorders at baseline will be invited to also participate in a serological follow-up. Consent for 
children less than 16 years will be sought from the mothers. Children aged 10 - 16 years will be 
asked for their assent to participate in the study. Based on the pilot study, we expect a 
participation proportion of 86% at the individual level for the serological component of the 
study. If the person selected at random in the concession refuses to participate, another 
number from the same concession will be selected at random until we get one person willing to 
participate. We expect 100% initial agreement for participation in the follow-up of neurological 
disorders only. Individuals younger than 5 years of age will be excluded from the sampling 
frame.  
 
The diagnostic of epilepsy will be determined in a similar way to what was done during the 
pilot study. The field staff will first interview the participants with the screening questionnaire. 
The 18-month follow-up questionnaire will exclude the socio-demographic section of the 
questionnaire and ask only about work absenteeism and the development of new symptoms. 
At baseline and at 18-months follow-up, the physician will collect a 10 mL blood sample from 60 
of the eligible participants on the day of, or the day following, the interview. The blood samples 
will be placed on ice in coolers until the evening when they will be centrifuged and refrigerated.  
When the screening is positive for epilepsy or headaches, the study physician will examine 
the participant to confirm or reject the probable occurrence of epileptic seizures or severe 
headache which may be secondary to NCC. All participants with CNS seizures or severe, 
progressively worsening headache as confirmed by the physician will be offered a cranial CT-
scan and treatment for the duration of the study if seizures are recurrent. The CT-scan will be 
done at the CHUYO. The images obtained during the pilot will be used to train the radiologists 
at the CHUSS in NCC diagnosis.  
 
Figure 4 illustrates the design of the RCT. Numbers in red correspond to the sample size for 
the follow-up of neurological disorders and in blue for the serological follow-up. These numbers 
represent sample sizes only and not mutually exclusive groups; i.e., those in the serological 
follow-up are part of the larger, neurological follow-up. 

 
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The process for randomizing 
villages into the intervention 
group (30 villages) or control 
group (30 villages) will take place 
prior to the 18-month post-
baseline follow-up. We will use a 
block randomization strategy 
with departments as the blocks. 
Village leaders and pig farmers 
from the participating 
concessions will be invited to 
attend a seminar offered by the 
local trainers. Illustrated 
educational materials will be 
distributed at the end of the 
seminar.  
 
Following the intervention, participants will be followed-up after 18 months. The same 
process as that described for the baseline survey and 18-month follow-up will be followed for 
the last visit. Prevalence at each visit and cumulative incidences between each visits will be 
calculated. 
E.  Statistical Methods   
 
The primary analysis will assess the effectiveness of the intervention and the effect of 
monitoring alone in reducing the incidence rate of human cysticercosis. We will first calculate 
estimates of the effectiveness of the intervention and the monitoring alone as incidence rate 
differences (IRDs) between the intervention and control groups. The variances for the 
95% confidence intervals (95% CI) of the crude effectiveness will be calculated for the control 
and the intervention groups, assuming a normal distribution. We will use a Bayesian 
hierarchical log binomial regression model for the number of incident cases of cysticercosis in 
humans. The model will include independent variables for the intervention, monitoring alone 
(pre or post period), village random effect, and any other confounding variable that was not 
well balanced after randomization. We expect to observe considerable between-village 
variability in cumulative incidences and prevalences, and will therefore plan to use a 
hierarchical model to account for these differences. These types of Bayesian hierarchical 
generalized linear models have been used extensively by the PI. All Bayesian analyses will be 
conducted using WinBugs 1.4©. 
60 participating villages
5280 neuro screenings
4080 serologies
2400 pigs
60 participating villages
4440 neuro screenings
3330 serologies
2400 pigs
30 intervention villages
2056 neuro screenings
1540 serologies
1200 pigs
30 control villages
2056 neuro screenings
1540 serologies
1200 pigs
BASELINE
18-MONTH 
FOLLOW-UP
RANDOMIZATION / 
INTERVENTION
R
18-MONTH
POST-RANDOMIZATION
FOLLOW-UP
480 (10%) neuro
outcomes replaced
Pre-randomization risk of human and 
porcine cysticercosis infection, and 
human neurological outcomes
328 (7.5%) losses to follow-up
250 (7.5%) losses to follow-up
Post-randomization risk of human and 
porcine cysticercosis infection and 
human neurological outcomes
Replace 480 prevalent 
neurological outcomes 
from same concession
360 (7.5%) losses to follow-up
270(7.5%) losses to follow-up
Expect
31 (1.5%) neuro outcomes
139 (9%) seroconversions
Expect
67 (1.5%) neuro outcomes
300 (9%) seroconversions
Expect
23 (1.1%) neuro outcomes
69 (4.5%) seroconversions
Fig. 4 Design of the randomized community-based trial for the neurological and serological outcomes

 
6 
F. Gender/Minority/Pediatric Inclusion for Research 
All inhabitants of the participating villages meeting the inclusion criteria based on age will 
have the opportunity to be included in this study. Thus, women and minorities meeting the 
eligibility criteria will have the possibility of being included.  
Pregnant women will be excluded from the CT-scan of the brain, due to the risk to the fetus. 
 
F.1. Distribution of Subjects by Sex/Gender and Racial/Ethnic Groups 
Targeted/Planned Enrollment Table 
Study Title: EFECAB: Improving pig management to prevent epilepsy in Burkina Faso - a randomized controlled trial 
Total Planned Enrollment: 
Maximum of 18288 
 
TARGETED/PLANNED ENROLLMENT: Number of Subjects 
Ethnic Category 
Sex/Gender 
Females 
Males 
Total 
Hispanic or Latino 
 
 
 
Not Hispanic or Latino 
 
 
 
Ethnic Category: Total of All Subjects * 
 
 
 
Racial Categories 
 
American Indian/Alaska Native 
 
 
 
Asian 
 
 
 
Native Hawaiian or Other Pacific Islander  
 
 
 
Black or African American  
9744 
8544 
18,288 
White 
 
 
 
Racial Categories: Total of All Subjects * 
9744 
8544 
18,288 
* The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories: Total of All Subjects.” 
 
F.2. Selection Criteria 
A total of 60 villages from the provinces of Sanguié, Boulkiemde and Nayala in Burkina Faso 
will be invited to participate in the randomized controlled community trial. In each village, a 
total of 80 subjects will be invited to take part in the follow-up study. Subjects to be included in 
the study will be selected at random, and there are no selection criteria based on sex/gender or 
racial/ethnic groups. The only criterion is that the included villages have some pig production. 

 
7 
This may lead to the exclusion of mainly Muslim areas where pigs and cysticercosis are less 
likely to be an issue.  
 
F.3. Rationale for Exclusion of Any Sex/Gender or Racial/Ethnic Group 
There is no such exclusion. The study is conducted in Burkina Faso where all the population 
living in rural areas is black.  
This proposal aims to establish the frequency of cysticercosis and NCC-associated 
neurological outcomes (single seizures, recurrent seizures and severe headaches) across the 
lifespan. Also, there is very little known about the incidence of infection or its neurological 
complications in children. Preliminary results in piglets suggest that age, as an indicator of 
immunological maturity, could have a major impact on the establishment of cysts in the body, 
including in the CNS. Pregnant women will also be included since their immunological response 
may be altered. However, pregnant women and children less than 5 years of age or those 
requiring sedation will not receive a CT-scan of the brain. 
 
F.4 Inclusion of children 
Since the entire village will be included in the study, children living in the village are eligible 
to be included. For the blood sampling and interview components of the study, children aged 5 
years and older will be included. The age of 5 years old was selected for inclusion in the study 
following discussions with the head of the ethical board for the Centre MURAZ (IORG0003562), 
Dr. Ouédraogo. This age was considered acceptable to ask for a blood sample and also for a CT-
scan, as long as it does not require sedation.   
All data collection, except for the CT-scan, will take place at the house of the child, which 
will minimize the stress levels. In our pilot study, the random selection of study participants led 
to the inclusion of 20% who were children less than 16 years old. This means that a sufficient 
number of children will be included to allow for a better understanding of the prevalence and 
incidence rates of T. solium in this population and the ages at which primary exposures can 
occur.  
Children older than 10 years of age will be asked for their assent to participate in the study. 
Individuals aged 16 years or older will be asked for their consent to participate in the study. 
Our research team is comprised of researchers and clinicians with considerable experience 
working with children in research and in clinical environments. Subjects’ recruitment, including 
children, and their follow-up will be conducted and supervised by research staff with training 
and experience working with children. In particular, Hélène Carabin, DVM, PhD is an infectious 
disease epidemiologist with experience working with pre-school children and staff in daycare 
centers to evaluate the effectiveness of an intervention to control infections. Dr. Cowan was 
the PI on a large epidemiological study of epilepsy in children in Oklahoma. Dr. Millogo, a 
neurologist, has numerous pediatric patients. Drs Ganaba and Hounton, as active research 
members of the IMMPACT project, have experience working with mothers in Burkina Faso.  
G. PROTECTION OF HUMAN SUBJECTS 
Human subject involvement and characteristics are summarized here. The purpose of the 
portion of the research project that involves human subjects is to conduct a randomized 

 
8 
controlled community-based trial to test the effectiveness of an education program focusing on 
improved pig management to reduce the incidence rate of human cysticercosis and associated 
neurological symptoms of neurocysticercosis (NCC) (single seizures, recurrent seizures and 
severe headaches) in 60 villages from 30 departments in three provinces of Burkina Faso. The 
initial 18 months of the study will be used to establish the baseline (18 months) cumulative 
incidence of cysticercosis infection and of the target neurological outcomes (single seizures, 
recurrent seizures or epilepsy and severe headaches). After the 18 month follow-up 
measurements, the 60 villages will be randomized to receive the education program (30 
villages) or to serve as a control (30 villages). All participants will be followed for an additional 
18 months. The control group will be offered the intervention at the end of the follow-up. 
 
G.1. Provide number, age range, and health status of the participant population.  Identify 
criteria for inclusion or exclusion. 
 
a. Anticipated number of subjects 
We are planning to follow two overlapping cohorts of people during the randomized 
community trial. One cohort will be followed for the development of the target neurological 
outcomes. We are planning to screen a total of 5280 people (4800+480) at baseline for 
assessing eligibility for the follow-up. The other cohort, which is a sub-set of the first, will be 
followed for the presence of antigens to the larval stages of Taenia solium in their blood. We 
are planning to enroll 3600 people at baseline for the serological component of the study 
(included in the 5280). Also, people with neurological disorders will be tested serologically, 
since the definition of NCC requires a serological test. This leads to 4080 serological tests to be 
conducted at baseline. 
 
Only people who are free of the target neurological outcomes (expected n=4800) will be 
followed-up for a period of three years, until they develop one of these outcomes, they drop 
out from the study, or the study ends. Assuming that 10% of people will have one of the target 
neurological outcome at baseline, a 5% annual proportion of losses to follow-up, an incidence 
rate of neurological outcomes of 1.5 per 100 persons every year, and a reduction in the 
incidence rate of 25% in the intervention group, we are expecting to measure the target 
neurological outcomes in 4440 and 4112 people at 18 and 36 months of follow-up, respectively.  
 
Subjects who have one of the target neurological outcomes -- confirmed by a physician -- at 
baseline or who develop one of them during the three year follow-up period, will be invited for 
a CT-scan of the brain. We anticipate referring a total of 656 subjects for a CT-scan of the brain 
during the study.  
 
For the serological component of the study, people will be followed-up for a period of three 
years, until they seroconvert, they drop out, or the study ends. Assuming a 5% annual 
proportion of losses to follow-up, we expect to follow-up 3330 and 3080 people at 18 and 36 
months, respectively. Please refer to the Figure in the methods section for a flow chart of the 
expected number of participating subjects at each stage of follow-up. 
 
A random sample will also be drawn of 40 concessions in which participants reside in order 
to collect data on and blood samples from their pigs. A total of 2400 pig managers will be 
interviewed. The person in charge of cooking for the household for each of the 5280 subjects 
screened for their eligibility will be questioned on household cooking habits. Finally, the head of 

 
9 
the household of each of the 5280 subjects screened will be asked about possessions and other 
factors used to measure the socio-economic level of the household. Some of those subjects 
may participate in the follow-up component of the study as well.  
 
During the preparation phase, 48 people from three villages not included in the randomized 
community trial (16 in each village from each of the study provinces), will be invited to 
participate to a focus group discussion on pig management, taeniasis, cysticercosis and 
epilepsy.  Results are used to develop the intervention materials. 
 
Please note that the enrollment form submitted with this proposal reflects the maximum 
number of people from whom we are expecting to collect any type of project-related data, 
including those individuals we are planning to follow as part of the randomized community 
trial. The numbers in the enrollment form were estimated as follows: 5280 (4800 originally 
selection plus 480 replacements of prevalent cases with the study neurological outcomes) 
participants screened at baseline with a sub-sample followed-up through time (assuming 50% 
men and 50% women), 2400 pig manager interviews (assuming 75% women) from the 
households of the selected participants, 5280 interviews of the person from the selected 
households who are in charge of cooking (assuming 100% women), from 4800 to 5078 
interviews of the head of the concession (assuming 100% men). This will be in addition to the 
250 people (129 women and 121 men) included in the focus group discussions. This results in a 
maximum number of persons from whom study data are collected (interviews and/or 
participants to the trial) of between 18,005 and 18,288 with an estimated 8161 to 8439 men 
and 9849 women. It is very possible that some of the interviewees will be included in more than 
one group resulting in a smaller number of total number of individuals participating in either 
interviews for collection of household data, focus groups or the trial itself.    
 
b. Age range of subjects 
The minimum age for the follow-up of the neurological outcomes and for the serological 
study will be 5 years of age. This is considered acceptable in Burkina Faso according to local 
investigators. There is no limitation on the maximum age. All participants who have one of the 
study neurological outcomes at baseline or who develop them during the follow-up will be 
offered a CT-scan of the brain. The minimum age for the CT-scan of the brain depends on the 
need for sedation. No CT-scan of the brain will be performed if sedation is required. More 
details on ages for providing informed consent and assent are given in the section, “Inclusion of 
Children”. 
 
c. Health status of subjects  
At baseline, we will select participants at random from the 60 participating villages. Hence, 
all village members are eligible to be included in the baseline study.  
As outlined in section (i) above, we expect that about 10% of the subjects will have one of 
the target neurological outcomes at baseline and will therefore be excluded from the follow-up. 
All other subjects are expected to be free from these outcomes. We expect that 12% of the 
subjects will be seropositive to the larval from of Taenia solium. Seropositive individuals at 
baseline will be included in the follow-up.  
 
d. Eligibility (inclusion and exclusion) criteria  

 
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The proposed project is a randomized community-based controlled trial. The first level of 
eligibility is the community. At the community level, provincial and departmental capitals (chef-
lieu), villages located on national  roads, villages not appearing on the official National Census 
map, villages in the vicinity of Koudougou or Ouagadougou, and neighboring villages (<5 km) 
will be excluded from the study. This is to prevent “contamination” of the intervention between 
villages. Village-level inclusion criteria are the presence of pig farming and of at least 1000 
inhabitants.  
At the individual level, the only exclusion criterion is being younger than 5 years of age.  
As described in (a) above, people who have a target neurological outcome at baseline or 
who develop them during the study period will be excluded from the next follow-up 
assessment. For the serological component of the study, all participants will be followed-up for 
both the serological and neurological outcomes.  
Pregnant women and subjects with one of the target neurological outcomes who would 
require sedation in order to obtain a CT-scan of the brain will be excluded from the radiological 
examination. 
 
G.2 Identify sources of research material in the form of specimens, records or data. 
Several interview questionnaires, which have been validated in the pilot study, will be 
further refined and used in this study. These include: 1) a screening questionnaire for seizures, 
recurrent seizures and severe headaches which includes demographic and socio-economical 
questions (screening questionnaire); 2) a household-level questionnaire to be administered to 
the head of the household (household questionnaire); 3) a “cooking” habits questionnaire to be 
administered to the mother of the household of the participant (cooking questionnaire); 4) a 
pig management questionnaire to be asked of the owner of the sampled pig (pig 
questionnaire); 5) a questionnaire to measure the costs associated with the treatment of 
epilepsy, to which questions on severe headaches will be added (cost questionnaire); a form 
which documents the findings of the history and physical examination by the study physician of 
those who screen positive for seizures or severe headache, to which questions on severe 
headaches will be added (medical questionnaire). A questionnaire for the focus group 
discussion (focus group questionnaire) will be used in three pilot villages to develop the 
educational material. All the material will be translated (and back-translated) to the local 
languages of the study regions (primarily Gourounsi). Not written version of those languages 
exists so this exercise will be done orally. 
The data from the CT-scans of the brain will be evaluated at the CHUYO by Prof. Cissé. The 
CT-scans will be saved on CD-roms and stored at the research office in Bobo Dioulasso. A sub-
sample of the de-identified CT-scans will be sent to the IENT as a quality assurance system. 
A maximum of four 10 ml blood samples each may be collected on any given subject 
participating in the serological component of the study: at baseline, at 18 months follow-up 
(and time of randomization), at 18 months post-randomization. All material necessary for the 
blood sampling and for the serological tests will be provided by the project. A centrifuge and 
generator will be purchased for the centrifugation of the sera in the field. A freezer and 
refrigerator and all storage materials will be purchased by the project for the IRSS for storing 
the sera.  

 
11 
All sera will be tested for circulating antigens of the metacestode of T. solium using the 
enzyme-linked immunosorbent assay (ELISA) (Brandt JRA, Geerts S, De Deken R, Kumar V, 
Ceulemans F, Brijs L, Falla N. A monoclonal antibody-based ELISA for the detection of circulating 
excretory-secretory antigens in Taenia saginata cysticercosis. Int J Parasitol 1992; 22:471-7). 
The test was found to have a sensitivity of 90% (95%BCI: 80-99%) and a specificity of 98% 
(95%BCI: 90-99%) to detect current infection in a study conducted in Ecuador (Praet N, Verweii 
JJ, Meape KE. Bayesian modelling to estimate the test characteristics of coprology, 
coproantigen ELISA and a novel real-time PCR for the diagnosis of taeniasis. Trop Med Int 
Health 2013, 18: 608-614). These analyses will take place at the IRSS in Bobo Dioulasso, Burkina 
Faso. 
Sera from all individuals confirmed to having severe chronic headaches or epilepsy or single 
seizures and a sub-sample of individuals without such samples matched for age group, sex and 
village residence will be tested with rES33 for the detection of taeniasis antibodies and rT24H 
for the detection of cysticercosis antibodies (Handali et al. Clin Vacc Immunol 2010; 17: 631-7). 
These analyses will take place at the Center for Disease Control and Prevention in Atlanta, USA. 
Once these analyses will have been completed, the remainder of the sera will be sent to 
Oklahoma for storage. 
Educational materials in the form of leaflets, posters, comic books and a movie will be 
produced for the intervention. The movie will be played using a generator during the 
educational sessions that are part of the intervention.  
A Sports Utility Vehicle will be purchased for the project to allow the research team to move 
between villages and to transport study materials.  
Each participant will be assigned a research identification number. Data retained on 
participants will only be identified by their research ID. Information linking participants to their 
research ID will be stored in secured files in the research office in Bobo Dioulasso and at the 
University of Oklahoma Health Sciences Center and will only be accessible to authorized 
research staff who have completed the Human Subjects Training required by the Institutional 
Review Board. 
All of the biological specimens and the interview assessments listed above will be collected 
specifically for the purposes of the proposed research project. The participants will be asked for 
their consent to bank the sera for a maximum of 5 years for potential future analyses on 
parasitic infections or inflammatory markers, but not for HIV. 
 
G.3. Plans for recruitment and consent procedures to be followed 
The first element of outreach will be a “launching” ceremony to which local policy makers 
and politicians will be invited. This will provide us with the opportunity to explain the goals of 
the study and its potential benefits to the region and the country. The second step will be to 
meet with the village leaders of each of the 60 eligible villages selected at random. The third 
step is the random selection of 80 concessions in each village and the consent of the concession 
“chief” to participate. The concessions will have been numbered before the random selection 
process. The fourth step is the selection of one person at random in the concession for 
participation in the 4-year study. The head of the household and mother of the household of 

 
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the participating subject will also be recruited for answering questions on the economical and 
cooking practices of the household.  
Three provinces in Burkina Faso will be selected based on location in an endemic area, 
proximity to a reference hospital and the known presence of pigs. One team consisting of one 
medical doctor, six interviewers and one veterinarian will visit 60 villages located in three 
provinces on four occasions: baseline, 18-months follow-up pre-randomization and 28-month 
follow-up post-randomization. The visiting of all 60 villages is expected to last less than 12 
months on each occasion. The project will first be launched publicly during a ceremony to be 
held in one of the three provinces. Then, Drs Millogo and Ganaba will supervise the team that 
will be introduced to the village head by a person of trust from the area. The research team and 
research project will then be introduced to villagers by the village heads. The village head 
and/or the village administrative committee will first be asked for their willingness to 
participate as a community in this initiative. 
We will modify the consent forms used during our pilot study and add a new one for the 
head of the household and for the focus group. The consent forms will include: 
1) Mothers: for an interview collecting data on cooking practices and household building 
characteristics. 
2) Head of household: for a short interview providing a census of household members and on 
possessions of the household. 
3) Villagers: for participating in the neurological outcome component of the study over a period 
of 4 years, with yearly screening interview for seizures, epilepsy and severe headaches and a 
clinical exam for those who screen positive and for the presence of subcutaneous nodules. This 
interview and clinical exam are expected to take around 20-30 minutes in total to complete. 
4) Villagers: for participating in the serological component of the study which involves taking a 
blood sample to test for T. solium infection on four occasions, one year apart. The blood sample 
is expected to take no longer than 5 minutes.  
5) Pig owners: for taking a blood sample and for completing a short questionnaire on pig 
management practices. The blood sampling of each pig should be completed in 10 minutes. 
6) Subjects screened positive for seizures and severe headache: for further testing with a brain 
CT scan in Ouagadougou, all fees reimbursed. The participant may need to take a day off work 
for this examination.  
7) A sub-sample of subjects screened positive and negative for seizures, epilepsy or severe 
headaches: for answering questions regarding costs associated with treatment of these 
conditions. 
8) A sub-sample in 3 villages one in each of the 3 participating provinces will be asked to 
participate in a focus group. Each focus group may take up to one hour. 
 
Informed consent will be obtained for all participants. All consent forms will include a first 
section where the objectives of the study are clearly stated. This will be followed by the 
description of what participation in the study will involve for the individual. Because we expect 
that a large proportion of the population will be illiterate, we expect the explanation to be read 
to the potential participants. Subjects that know how to sign their name or mark will be ask to 
do so on a form that clearly explains, in simple words of the local language, the objectives of 
the study. Children older than 10 years of age will be asked for their assent to participate in the 

 
13 
study. Individuals aged 18 years or older will be asked for their consent to participate in the 
study. The consent will clearly state that Individuals may terminate participation at any time.  
a. Location where consent is most likely to take place 
During our pilot project, all consents successfully took place in the household of the 
participant. We will use this same approach for this study. 
 
b. Provisions for recruiting non-English speaking participants 
All participants will be non-English speakers. We will recruit research staff who are familiar 
with the local languages and native speakers. 
 
c. Measures to decrease coercion of participants 
All research staff will be Burkinabè people. We will also make an effort to recruit people 
from the research area to be part of the research staff. The study protocol will be submitted to 
the Centre MURAZ ethical committee which is recognized by the Office of Human Research 
Protections (OHRP) (Centre MURAZ (IORG0003562)). This committee has replaced the previous 
IRB which was linked to the CHUSS through the Federal Wide Assurances (FWA) during the pilot 
(FWA00009934). We will renew our FWA with the new International IRB for Burkina. Their 
review will be essential to make sure that our approach is not coercive. The study will be clearly 
explained to each participant orally in their own language (if they cannot read, which we expect 
in the majority of people). There will be a clear statement that participation is optional and 
there is no penalty for non-participation.  
All participants will be given a bag of sugar (600 CFA or $1.45) each time that they answer 
questions and/or provide a blood sample as a compensation for their time. In a very deprived 
environment such as that of Burkina Faso, sugar is a most welcomed compensation. The village 
leaders will also be given a 10,000 CFA (~$24) compensation to purchase something for the 
community each time the village is visited.  These compensations have been recommended by 
our local collaborators and are not considered to be of a magnitude that is coercive. 
 
G.4. Risks and assessment of likelihood and seriousness. 
The potential risks associated with this protocol are minimal. There are minor risks 
associated with drawing blood such as possible bruising, infection, and fainting. Subjects 
participating to the serological component of the study will be asked for their consent to inform 
the local health care provider of their serological status if they test positive for T. solium. This is 
because the results of the serology will only be available a few weeks after the samples have 
been drawn. The local health care provider will be given albendazole to treat persons who are 
antigen positive but do not have neurological symptoms. The project will provide these 
treatments. Provision of this free treatment is likely to be a benefit to the participants.  
Brain CT scans will only be offered to individuals with unprovoked single or recurrent 
seizures or severe headaches. This is often part of the normal workup for identifying the causes 
of these disorders. Given that most people in Burkina Faso cannot afford this test, the brain CT 
scan will most likely be a benefit to them. Pregnant women and children needing sedation will 
not be offered the CT-scan.  
We will use a consent form, modified to include severe headaches, like that used during our 
pilot study. The following statement regarding the risks associated with the CT-scan reads: 

 
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“I am being asked to have a special test on my brain because I have seizures.  I am being asked 
to go to Ouagadougou for a brain-scan study (computerized tomography or CT scan).  The brain 
scan is the best way to determine whether my seizures are caused by the worm, T. solium, in my 
brain.  The brain scan might also help to determine other possible causes of my epilepsy.  The CT 
scan requires that I lie still for a short time while pictures are taken of my brain.  I understand 
that I will feel no pain with the brain scan, but that I may be bothered by the noise and the 
closed-in-space.  Someone will be watching me all the time and I will be able to speak to them, 
so they will stop the scan at any time if I ask them to.  I also understand that the CT scan uses an 
amount of radiation that is somewhat above the amount I receive normally from the 
environment.  During this special test, I will be injected into a vein with a dye called iodine.  This 
will help the doctors to see any abnormal areas of my brain.  I understand that the iodine causes 
some people to have an unusual taste in their mouth and a feeling of warmth throughout their 
body, but only for a very short time.  I also understand that some people rarely have a mild 
headache, nausea, vomiting, chills, fainting or allergic-type reactions.  If I am a woman and I am 
pregnant, I should not have iodine injected in one of my veins for the CT scan examination. I will 
have a free urine test to rule out pregnancy if there is a possibility that I may be pregnant. 
I am agreeing to disclose medical information related to my health.” 
Only minimal risks are associated with the interviews and include possible distress to 
persons recalling their seizure histories.  
To avoid economical losses to their owners, we will not attempt to take blood samples from 
pregnant sows or piglets younger than 2 months to avoid harmful stress to the animal and 
potential spontaneous abortion of the sows (stress associated).  
All individuals who are identified as suffering from single seizures, epilepsy or severe 
headaches will be treated accordingly to the recommendations of Dr Millogo for the duration of 
the research project (money has been allocated in the budget to do this). Those identified by 
CT-scan to have NCC will also be treated for their condition as appropriate. At the end of the 
research project, these subjects will be encouraged to obtain treatment from the local health 
care provider. This approach was successful during the pilot study, especially in Batondo, a 
village located in one of the three provinces targeted for the proposed study.  
 
G.5 Procedures for protecting against or minimizing potential risks 
Subjects who consent to participate in the study will be identified by name and with an 
alphanumeric code. Only one coding sheet linking the names to the codes will be created and it 
will be password protected. Every effort will be made to keep the subject’s personal data 
confidential. As the study progresses, data will be entered in Burkina Faso into a password-
protected database. All consent forms and the coding sheet will be maintained in a locked file 
cabinet in the study’s secure research office. In keeping with local practice, the office will also 
be monitored by security staff working for the project. Any data sent to the COPH will be 
anonymous and with alphanumeric codes for the subjects, pigs, households and village names. 
Published reports will not use names or any other information that could be used to identify 
individual study participants. 
During our pilot study, none of the 77 subjects who received a CT-scan of the brain 
experienced any side effects from the procedure, either with or without the use of contrast. 

 
15 
Among those, there were 8 children aged between 7 and 9 years old. No sedation was required 
for these children.  
At the CHUYO, for the entire 2-year interval between April 2006 and April 2008, out of 885 
patients who received a CT-scan with contrast, there were 30 cases of vomiting (3.4%) and five 
cases of vertigo (0.6%). The staff of the Department of Radiology at the CHUYO interviews 
patients a few days prior to conducting the CT-scan to obtain information regarding risk factors 
for side effects. Those at high risk will not receive the contrast media. Those with a history of 
iodine allergy are excluded; those with drug allergies or seasonal allergies are given anti-
histamines several days prior to the examination. The radiology department is located in the 
hospital with access to an emergency room and also has a provision of hydrocortisone, oxygen 
and adrenaline to treat potentially severe side effects. 
Subjects who may require sedation for the CT-scan of the brain will be excluded from this 
part of the study. Pregnant women will be excluded from the CT-scan of the brain to avoid any 
risk to the fetus. 
 
G.6. Potential benefits and importance to the participants and others 
The benefits of the information gained from the study outweigh the minimal risk involved.  
All participants will be given a bag of sugar (600 CFA or $1.45) each time that they answer 
questions and/or provide a blood sample as a compensation for their time. In a very deprived 
environment such as that of Burkina Faso, sugar is a most welcomed compensation. The village 
leaders will also be given a 10,000 CFA (~$24) compensation to purchase something for the 
community each time the village is visited.   
Subjects screening positive for seizures or severe headaches based on the individual 
questionnaire will receive a free physical examination to confirm the diagnosis and to look for 
the presence of subcutaneous nodules. Subjects with confirmation of their seizures or severe 
headaches will be invited for a brain CT scan in order to better understand the basis of their 
symptoms. These individuals will be offered appropriate, free treatment for the remainder of 
the project. They will be monitored through the usual care provided at local clinics. The initial 
course of treatment will be recommended by the medical intern under the supervision of Dr. 
Millogo. All participants live in Burkina Faso, Africa; no subjects will be studied at Oklahoma 
Health Sciences Center sites.  
Subjects will be asked for their consent to inform the local health care provider of their 
infection status based on the AgELISA. Those found seropositive will be offered a course of 
albendazole treatment. 
Owners of pigs found infected with T. solium will be informed of the risk of consuming this 
meat raw or undercooked. They will be advised to either destroy the meat or to cook it very 
well. This approach has been found acceptable in regions of southeastern Africa.  
If the educational intervention is effective, we expect to reduce the incidence rate of 
cysticercosis infections by 50% in humans and pigs. We also expect to reduce, in the long term, 
the incidence rate of seizures, recurrent seizures and severe headaches by at least 25%. Given 
the important stigmatization associated with epilepsy and the monetary value of pork these 
results would have a tremendous impact on the health and well-being of these communities. 

 
16 
Potential benefits to others include the development of a cost-beneficial intervention to 
prevent a large proportion of epilepsy and severe headaches in developing countries where 
pigs are raised. It will also potentially increase the income of pig producing farming 
communities.  
The results from this study could have a tremendous impact on reducing the prevalence of 
epilepsy in African countries where cysticercosis is endemic. Other benefits include the possible 
increase in income for pig farmers through improved management, which could lead to 
improvement growth and fertility of pigs, and ultimately to an improvement in nutrition and 
increasing school attendance. This is because women are typically in charge of pig raising in 
that part of the world and the benefits from selling pigs are managed by them. If the education 
program also improves sanitation, the project may also reduce the rate of diarrhea and 
parasitic infections. To assess this, we have included a question on diarrhea in our 
questionnaire. 
 
 
Discuss why risks are reasonable in relation to benefits. 
The basis of this assessment are discussed in detail above. 
 
H.  Data and Safety Monitoring Plan  
This study is not a clinical trial. None of the DSMP mechanisms apply to this study. Brain CT 
scans will only be offered to individuals with unprovoked single or recurrent seizures or severe 
headaches. This is often part of the usual diagnostic workup for identifying the causes of these 
disorders.