Comparison of school and community-based mass drug administration delivery strategies for control of Schistosoma mansoni infections in western Kenya in areas with >25% prevalence

• Register: ISRCTN
• Last refreshed on: 16 January 2023
• Main ID: ISRCTN16755535
• Date of registration: 14/12/2015
• Prospective Registration: No
• Primary sponsor: University of Georgia Research Foundation / SCORE (USA)
• Public title: Comparison of school and community-based mass drug administration delivery strategies for control of Schistosoma mansoni infections in western Kenya in areas with >25% prevalence
• Scientific title: Comparison of school and community-based mass drug administration delivery strategies for control of Schistosoma mansoni infections in western Kenya in areas with >25% prevalence: a multi-centre randomized intervention trial
• Date of first enrolment: 01/12/2010
• Target sample size: 105000
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN16755535
• Study type: Interventional
• Study design: Multi-centre randomized intervention trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Kenya

Contacts

• Name: Pauline Mwinzi

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- year-old children each study year
6. At least one stool sample provided from first-year students and adults in years 1 and 5

Exclusion criteria:
1. Children not aged 9-12 years (in years 2, 3 and 4)
2. Adults in Years 2, 3 and 4
2. Children under 9 in Years 2, 3, 4
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 and adults in years 1 and 5)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Schistosomiasis
Infections and Infestations
Schistosomiasis due to Schistosoma mansoni [intestinal schistosomiasis]

Intervention(s)

In the first step, in-depth parasitological surveys are carried out to identify 150 schools where the prevalence of S. mansoni (i.e., number of infections) amongst schoolchildren is greater than 24%. Prevalence during this eligibility step 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 six groups.
Group 1: School-age children and adults are treated with praziquantel once a year for the 4 years of the study
Group 2: School-age children and adults are treated for the first two years of the study and only school-age children are treated for the last two years
Group 3: School-age children and adults are treated for the first two years of the study and receive no treatment in the last two years
Group 4: School-age children are treated every year
Group 5: School-age children are treated for the first two years
Group 6: School-age children are treated for the first year and the third year

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 in schools and by drug distributors in the community MDA venues.

Primary Outcome(s)

Identification of the most cost-effective strategy that is able to reduce S. mansoni infection from high prevalence levels, measured by change in prevalence and intensity of Schistosoma mansoni infection in 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 150 schools
4. Identification of S. mansoni risk factors
5. Mapping and prediction of the distribution of 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)

N/A

Source(s) of Monetary Support

Bill and Melinda Gates Foundation

Ethics review

Status:
Approval date:
Contact:

Kenya Medical Research Institute, 01/09/2010, ref: KEMRI/RES/7/3/1

Results

• Results available: Yes
• Date Completed: 31/12/2016