Sustaining the control of intestinal schistosomiasis mansoni in western Côte d'Ivoire

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN99401114
• Date of registration: 12/11/2014
• Prospective Registration: No
• Primary sponsor: Swiss Tropical and Public Health Institute (Switzerland)
• Public title: Sustaining the control of intestinal schistosomiasis mansoni in western Côte d'Ivoire
• Scientific title: Sustaining control of schistosomiasis mansoni in moderate endemicity areas in western Côte d'Ivoire
• Date of first enrolment: 01/12/2011
• Target sample size: 42500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN99401114
• Study type: Interventional
• Study design: Randomised intervention trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Cote d'Ivoire

Contacts

• Name: Jürg Utzinger

Key inclusion & exclusion criteria

Inclusion criteria: 1. Schoolchildren, either male or female, aged 9-12 years, attending the selected schools (in each study year)
2. First-year students, either male or female, attending the selected schools (in years 1 and 5)
3. Written informed consent signed by parents or legal guardians of the schoolchildren
4. Oral assent from schoolchildren
5. At least one stool sample provided over three consecutive days from 9- to 12- years- old children each study year
6. At least one stool sample provided from first-year students in years 1 and 5
Exclusion criteria: 1. Children not attending the selected schools
2. Children not aged 9-12 years (in years 2, 3 and 4)
3. Children not aged 9-12 years or being first-year students (in years 1 and 5)
4. No written informed consent by parents or legal guardians of schoolchildren
5. No oral assent given by schoolchildren
6. No stool sample provided (for 9- to12-year-old children in each study year; for first-year students in years 1 and 5)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Schistosoma mansoni infection
Infections and Infestations
Schistosomiasis (bilharziasis)

Intervention(s)

The study will be implemented in 75 schools of western Côte d'Ivoire. The 75 schools are randomly assigned to three study arms (25 schools per arm)
1. Schools of arm A: treated annually with praziquantel in years 1, 2, 3 and 4
2. Schools of arm B: treated with praziquantel in the first two years (years 1 and 2)
3. Schools of arm C: treated with praziquantel in year 1 and again in year 3

Primary Outcome(s)

As of 21/03/2016:
Prevalence and intensity of S. mansoni infections in 9- to-12- year-old schoolchildren.

Initial:
Identification of the most cost-effective strategy that is able to reduce S. mansoni infection from moderate (10-24%) to low prevalence levels (<10%). Measured by change in prevalence and intensity of Schistosoma mansoni infection in cohorts of 9- to 12-year-old children over the four years of intervention.

Secondary Outcome(s)

As of 21/03/2016:
1. Prevalence and intensity of S. mansoni infections in first-year schoolchildren
2. Control of morbidity due to S. mansoni (reduction of the prevelance to <10%) in the 75 schools
3. Identification of S. mansoni risk factors
4. Mapping and prediction of the distribution S. mansoni in western Côte d'Ivoire

Initial
1. Prevalence and intensity of S. mansoni infections in 9- to-12- year-old schoolchildren
2. Prevalence and intensity of S. mansoni infections in first-year schoolchildren
3. Control of morbidity due to S. mansoni (reduction of the prevelance to <10%) in the 75 schools
4. Identification of S. mansoni risk factors
5. Mapping and prediction of the distribution S. mansoni in western Côte d'Ivoire

Measured by changes in force of transmission, as assessed by infection prevalence and intensity of S. mansoni in first-year students and adults.

Secondary ID(s)

N/A

Source(s) of Monetary Support

The Bill & Melinda Gates Foundation through the Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) based at the University of Georgia (sub-awards no. RR374-053/4893196), The Schistosomiasis Control Initiative - Imperial College (SCI; London, United Kingdom) donates praziquantel tablets