Gaining and sustaining control of Schistosomiasis in Cabo Delgado, Mozambique where the starting prevalence is greater than 25%

Not Applicable

Completed

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

• Registration Number: ISRCTN14117624
• 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 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30439945 results 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) 2020 Other publications in https://doi.org/10.4269/ajtmh.19-0829 Impact of Different Mass Drug Administration Strategies for Gaining and Sustaining Control of Schistosoma mansoni and Schistosoma haematobium Infection in Africa (added 20/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-14
• Study Completion: 2015-12-31
• Last Update Posted: 30 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 urine sample provided over three consecutive days from 9- to 12-year-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
3. Children under 9 in Years 2, 3, 4
4. No written informed consent by parents or legal guardians of schoolchildren
5. No oral assent given by schoolchildren
6. 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
Identification of the most cost-effective strategy that is able to reduce S. haematobium infection from high prevalence levels measured by change in prevalence and intensity of Schistosoma haematobium infection in 9- to 12-year-old children over the four years of intervention.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Prevalence and intensity of S. haematobium infections in 9- to-12- year-old schoolchildren.<br> 2. Prevalence and intensity of S. haematobium infections in first-year schoolchildren.<br> 3. Control of morbidity due to S. haematobium (reduction of the prevalence to <10%) in the 150 schools<br> 4. Identification of S. haematobium risk factors<br> 5. Mapping and prediction of the distribution S. haematobium in Cabo Delgado Region, Mozambique.<br><br> Measured by changes in force of transmission, as assessed by infection prevalence and intensity of S. haematobium in first-year students and adults.<br>