Plain English Summary
Background and study aims
New estimates suggest that 1.4 million people die from diarrhoea each year. Diarrhoea is still he second most important cause of death for children under 5. Although this has significantly decreased over the past 20 years, there are still 2.9 billion cases of diarrhoea each year. Furthermore, hundreds of millions of people suffer from helminthiasis (infection caused by worms called helminths) and intestinal protozoa infections, particularly in the developing world. More than half of the human population is at risk of soil-transmitted helminthiasis and schistosomiasis (alos caused by parasitic worms) over 1 billion people are infected, and the global burden is 10 million disability-adjusted life years (DALYs). The global strategy to control helminthiasis is preventive chemotherapy, that is the regular administration of anthelminthic drugs to at-risk populations. Re-infection after treatment can occur rapidly as long as access to clean water and adequate sanitation has not been improved and hygiene behaviour remains unchanged. Integrated approaches are necessary in order achieve control and elimination in the longer term in countries with limited resources.
This study deals with an integrated and sustainable approach for the control of neglected tropical diseases and diarrhoea. The aim is to assess and quantify the effect of preventive chemotherapy combined with community-led total sanitation (CLTS) and community health education programme (CHEP) on reinfection patterns of soil-transmitted helminths, schistosomes and intestinal protozoa, and diarrhoea in 40 communities in south-central Côte dIvoire. A video-based cartoon as part of the CHEP will be developed and tested in 20 schools.
Who can participate?
All children of 20 schools (grades 3-6) and members of 40 communities (community members aged 12-24 months, 5-15 years and >15 years) with written informed consent or children aged <18 years with written informed consent from parental/legal guardian will be invited to participate in the parasitological examination, diarrhoea monitoring and the Knowledge, Attitude, Practice and Belief (KAPB) surveys. In all 40 communities, members of the community are invited to participate in the implementation of CLTS and CHEP sessions using participatory rural appraisal (PRA) methods.
What does the study involve?
In a first step, the CHEP will be developed. That includes an animated cartoon for hygiene and health that is targeted at school-aged children and a community health theatre for the entire community. The cartoon will be screen-played to schoolchildren attending grades 3-6 in 10 schools out of 20 schools and its impact on neglected tropical diseases and defecation-related knowledge, attitude, practice and beliefs (KAPB) compared to the other 10 schools that did not see the cartoon. Before the showing the cartoon, parasitological and KAPB surveys will take place among 100 schoolchildren from grades 3-6 per school. These surveys will be repeated 12 months later.
In a second step, 40 communities will benefit from different intervention packages (integrated control packages). While all these 40 communities will receive preventive chemotherapy, 10 communities will additionally receive a CHEP intervention, another 10 will receive a CLTS intervention, and 10 communities will receive both CHEP and CLTS interventions. To increase our understanding of helminth and intestinal protozoa infection, diarrhoea frequency and schoolchildren's and communities defecation-related KAPB and the effect of CLTS and CHEP on these aspects, a number of quantitative studies will be carried out using questionnaires, key informant interviews (KIIs) and focus group discussions (FGDs). The initial parasitological examinations and KAPB assessment will take place in 30 randomly selected households in each of the 40 communities.
What are the possible benefits and risks of participating?
All participants profit from repeated de-worming with albendazole, one of the drugs of choice according to World Health Organization recommendations, and praziquantel (administration free of charge). Both treatments work well against the common soil-transmitted helminths and schistosomiasis and have good safety profiles. The interventions on health education and sanitation will improve sanitation and health profiles of the participating school classes and communities.
There are no specific risks associated with this study, although the submission of stool and urine samples by adult study participants might be perceived as shameful. Furthermore, albendazole and praziquantel used for preventive chemotherapy might result in some adverse events, but these are usually few, mild and quickly disappear.
Where is the study run from?
The study will be conducted in 20 rural primary schools of Western Côte d'Ivoire and in 40 entire communities of South-Central Côte d'Ivoire.
When is study starting and how long is it expected to run for?
The study will start in March 2014 and will run for approximately 2 1/4 years.
Who is funding the study?
The study is funded by the UBS Optimus Foundation
Who is the main contact?
Dr Giovanna Raso
giovanna.raso@unibas.ch
Trial website
Contact information
Type
Scientific
Primary contact
Dr Giovanna Raso
ORCID ID
Contact details
Socinstrassse 57
Basel
4002
Switzerland
-
giovanna.raso@unibas.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An integrated approach to fight neglected tropical diseases and diarrhoea
Acronym
Study hypothesis
Our integrated approach, consisting of preventive chemotherapy combined with either community health education or community-led total sanitation or both, will decrease the incidence of helminth and intestinal protozoa infections and diarrhoea and improve health-related hygiene knowledge and behaviour.
Ethics approval
1. Basel Ethics Committee (EKBB, Switzerland), 11 November 2013, reference no. 300/13
2. Comité National dEthique et de la Recherche (CNER, Côte dIvoire), 28 November 2013, reference 76-2013/MSLS/CNER-dkn
Study design
Cluster randomized intervention trial with repeated cross-sectional parasitological and questionnaire surveys before intervention (baseline) and 12 and 24 months post-intervention (follow-up 1 + 2).
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Neglected tropical diseases (soil-transmitted helminths, schistosomes, intestinal protozoa) and diarrhoea
Intervention
Praziquantel (single 40 mg/kg dose according to a dose pole for individuals aged >4 years) and albendazole (single 400 mg dose for individuals aged >2 years and single 200 mg dose for 1-2 year old children), which are safe and efficacious drugs against schistosomiasis and soil-transmitted helminthiasis, will be given to the whole study population in the 20 schools and the 40 communities. Among the 20 schools, 10 schools will be randomly selected and will have the animated health educational cartoon screen-played. Furthermore, while all these 40 communities will receive preventive chemotherapy, 10 communities will additionally receive a community health education programme (CHEP) intervention that includes the animated health educational cartoon that is targeted at school-aged children and a community health theatre for the entire community, another 10 communities will receive a community-led total sanitation (CLTS) intervention, and 10 communities will receive both CHEP and CLTS interventions. CHEP and CLTS interventions will be randomly assigned to communities.
Within each community 30 households will be randomly selected and their members invited for parasitological, anthropometric and KAPB investigations before the interventions and at 12 and 24 months post-intervention. Diarrhoea monitoring will as well be undertaken in these households during 24 months at a 2 week interval. At the 20 schools, only children from grades 3-6 will be invited for parasitological and KAPB assessment before intervention and 12 months after the baseline.
Intervention type
Drug
Phase
Not Applicable
Drug names
Praziquantel, albendazole
Primary outcome measure
Reinfection rates with soil-transmitted helminths, schistosomes and intestinal protozoa and incidence of diarrhoea episodes 12 and 24 months after the baseline survey
Secondary outcome measures
KAPB with regard to sanitation and nutritional status of infants at baseline and 12 and 24 months after baseline
Overall trial start date
01/04/2014
Overall trial end date
30/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Primary school child, aged 5-15 years (grades 3-6), male or female in the schoolbased survey
2. Infants aged between 12-24 months, children aged 5-15 years, young adults or adults aged above 15 years in the community survey
3. Written informed consent by a parent/guardian on behalf of the child younger than 18 years or written informed consent by adult participant
4. Submission of 1 urine and 1 stool sample at baseline
5. Completion of questionnaire by head of household in the community survey at baseline
6. Absence of difficult health condition as assessed by a medical doctor at baseline
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
2000 children from 20 schools, 7880 participants from 40 communities
Participant exclusion criteria
1. Children below 5 years or above 15 years in the school based survey
2. Children below the age of 12 months or between 2 and 4 years
3. No written informed consent
4. No complete set of urine and stool sample submitted at baseline
5. No completion of questionnaire by head of household in the community survey at baseline
6. Presence of medical condition that prevents child from participating to the study
Recruitment start date
01/04/2014
Recruitment end date
30/09/2016
Locations
Countries of recruitment
Cote d'Ivoire
Trial participating centre
Socinstrassse 57
Basel
4002
Switzerland
Sponsor information
Organisation
Swiss Center for Scientific Research (Cote d'Ivoire)
Sponsor details
Centre Suisse de Recherches Scientifiques en Côte d'Ivoire)
KM 17 route de Dabou
Adiopodoumé
Yopougon
B.P. 1303
Abidjan
01
Cote d'Ivoire
-
giovanna.raso@unibas.ch
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
UBS Optimus Foundation (Project No 3254.01)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29895511