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

Not Applicable

Completed

• Conditions: Schistosomiasis; Infections and Infestations; Schistosomiasis due to Schistosoma mansoni [intestinal schistosomiasis]

• Registration Number: ISRCTN16755535
• Lead Sponsor: niversity of Georgia Research Foundation / SCORE (USA)

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27230666 protocol and baseline data 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32400356/ results (added 11/02/2021) 2017 Interim results article in https://doi.org/10.1371/journal.pone.0181975 pilot study results (added 04/01/2023) 2020 Other publications in https://doi.org/10.4269/ajtmh.19-0805 Challenges in Protocol Development and Interpretation (added 04/01/2023) 2017 Protocol article in https://doi.org/10.1186/s12879-017-2738-5 Protocol and baseline data for a multi-year cohort study (added 04/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-14
• Study Completion: 2016-12-31
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 105000

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified