Study and implementation of urogenital schistosomiasis elimination in Zanzibar (Unguja and Pemba islands)

Not Applicable

Completed

• Conditions: Schistosoma haematobium infections; Infections and Infestations; Schistosomiasis due to Schistosoma haematobium [urinary schistosomiasis]

• Registration Number: ISRCTN48837681
• Lead Sponsor: atural History Museum (UK)

Brief Summary

2012 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/23110494 protocol 2013 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24147165 results 2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/25973845 results 2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26329827 results 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26727915 results 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27399310 results 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27428066 results 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27498244 results 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27986092 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30352631 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31255591 results (added 02/07/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31059495 results (added 03/01/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32887642/ qPCR results (added 07/09/2020) Results article in https://pubmed.ncbi.nlm.nih.gov/36215334/ Population genetic analysis of Schistosoma haematobium (added 11/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-05
• Study Completion: 2017-12-31
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72000

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. Adults aged 20-55 years from the selected communities (shehias), only one adult per household, pregnant women are eligible (in years 1 and 5)
4. Submitted written informed consent sheet signed by parent or legal guardian in case of participating children or signed by the participant in case of participating adults
5. Oral assent from participant given
6. One urine sample provided (from 9-12-year old children in each study year; from first-year students and adults in years 1 and 5)
7. One blood sample obtained (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. Adults not resident in the selected shehias
5. Adults aged <20 or >55 years (in years 1 and 5)
6. Written informed consent not submitted or not signed by parent or legal guardian in case of participating children or not signed by the participant in case of participating adults
7. No oral assent given
8. No urine sample provided (for 9-12-year old children in each study year; for first-year students and adults in years 1 and 5)
9. No blood sample obtained (from first-year students in years 1 and 5)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 25/03/2019:<br> S. haematobium infection prevalence and intensity based on urine filtration results in 9- to 12-year-old children after five years of follow-up (i.e. at the 5-year endline survey in 2017)<br><br> Previous primary outcome measure:<br> Elimination of urogenital schistosomiasis in Unguja and reduction of the S. haematobium prevalence <10% in Pemba after 5 years of interventions<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Prevalence and intensity of S. haematobium infections in 9-12-year-old schoolchildren and antibody levels against S. haematobium in first-year students, hence judging current infection status and history of exposure, and prevalence and intensity of S. haematobium infections in adults and first-year students<br> 2. Impact of niclosamide on snail populations, schistosome transmission and reinfection of the Zanzibari population<br> 3. Changes in the behaviour of the human population associated with parasite transmission<br> 4. Sensitivity and specificity of novel diagnostic methods<br>