Sustaining the control of intestinal schistosomiasis mansoni in Western Kenya

• Register: ISRCTN
• Last refreshed on: 20 November 2017
• Main ID: ISRCTN14849830
• Date of registration: 18/11/2015
• Prospective Registration: No
• Primary sponsor: University of Georgia Research Foundation / SCORE
• Public title: Sustaining the control of intestinal schistosomiasis mansoni in Western Kenya
• Scientific title: Comparison of school-based mass drug administration delivery strategies for control of Schistosoma mansoni infections in Western Kenya
• Date of first enrolment: 01/12/2010
• Target sample size: 40000
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14849830
• Study type: Interventional
• Study design: Randomised intervention trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Kenya

Contacts

• Name: Diana Karanja

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 aged 9-12 years (in years 2, 3 and 4)
2. Children not aged 9-12 years or being first-year students (in years 1 and 5)
3. No written informed consent by parents or legal guardians of schoolchildren
4. No oral assent given by schoolchildren
5. No stool sample provided (for 9- to 12-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

Schistosomiasis
Infections and Infestations

Intervention(s)

In a first step, in-depth parasitological surveys are carried out in 75 schools where the prevalence of S. mansoni (i.e. number of infections) amongst schoolchildren ranges between 10% and 24%. Prevalence is measured using Kato-Katz thick smears from 50 children aged 13-14 years per locality.

Each school is then randomly allocated into one of three groups. Schoolchildren attending schools in group 1 are treated with praziquantel once a year for the 5 years of the study. Schoolchildren attending schools in group 2 are treated for the first two years of the study. Children attending schools in group 3 are treated in the first year and the third year of the study. Three days of consecutive parasitological surveys are carried out before each treatment to assess any changes to the prevalence and intensity (severity of infection) of S. mansoni infection over time. The praziquantel is administered by trained teachers to all children aged 5-15 years.

Primary Outcome(s)

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)

1. Prevalence and intensity of S. mansoni infections in 9- to-12- year-old schoolchildren, using Kato-Katz thick smears
2. Prevalence and intensity of S. mansoni infections in first-year schoolchildren, using Kato-Katz thick smears
3. Control of morbidity due to S. mansoni (reduction of the prevalence to <10%) in the 75 schools
4. Identification of S. mansoni risk factors
5. Mapping and prediction of the distribution S. mansoni in Western Kenya

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)

Sm1 4787606

Source(s) of Monetary Support

Bill and Melinda Gates Foundation