Community-wide and School-based Mass Drug Administration (MDA), using praziquantel, given once each year compared to Community-wide and School-based Mass Drug Administration (MDA) given twice each year, six months a part, in gaining and sustaining control of Schistosoma haematobium

Not Applicable

Completed

• Conditions: Schistosomiasis; Infections and Infestations

• Registration Number: ISRCTN32045736
• Lead Sponsor: niversity of Georgia Research Foundation / SCORE

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/10.1186/s12879-017-2738-5 Protocol and baseline data for a multi-year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four African countries (added 20/01/2023) 2020 Other publications in https://doi.org/10.4269/ajtmh.19-0805 Challenges in Protocol Development and Interpretation of the Schistosomiasis Consortium for Operational Research and Evaluation Intervention Studies (added 20/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-16
• Study Completion: 2016-06-30
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 145000

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 urine sample provided from 9- to 12- years- old children each study year
6. At least one urine 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 urine 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

Primary Outcome Measures

Name	Time	Method
MDA strategy that is able to reduce S. haematobium infection measured by change in prevalence and intensity of Schistosoma haematobium infection in 9- to 12-year-old children is measured at baseline, 1, 2, 3 and 4 years by filtering the urine and preparing slide for microscopic exam. In addition, the urine is observed to see if hematuria visible.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Prevalence and intensity of S. haematobium infections in 9- to-12- year-old schoolchildren is measured at baseline, 1, 2, 3 and 4 years using urinalysis<br> 2. Prevalence and intensity of S. haematobium infections in first-year schoolchildren is measured at baseline, 1, 2, 3 and 4 years using urinalysis<br> 3. Identification of S. haematobium risk factors is measured by collecting village inventory data about water, sanitation, hygiene and water body contact at baseline, 1, 2, 3 and 4 years<br> 5. Mapping and prediction of the distribution S. haematobium in Niger is measured by collecting and using GIS coordinates of schools, water bodies and water and sanitation infrastructure at baseline, 1, 2, 3 and 4 years<br>