Surveys for assessment of urogenital schistosomiasis in pre-school, school-aged children, adolescents and adults in Zanzibar (Unguja and Pemba Islands)

• Register: ISRCTN
• Last refreshed on: 10 August 2020
• Main ID: ISRCTN17656730
• Date of registration: 27/07/2020
• Prospective Registration: No
• Primary sponsor: Swiss Tropical and Public Health Institute
• Public title: Surveys for assessment of urogenital schistosomiasis in pre-school, school-aged children, adolescents and adults in Zanzibar (Unguja and Pemba Islands)
• Scientific title: Repeated cross-sectional surveys for monitoring urogenital schistosomiasis in pre-school, school-aged children, adolescents and adults in Zanzibar (Unguja and Pemba Islands)
• Date of first enrolment: 15/02/2018
• Target sample size: 26970
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN17656730
• Study type: Observational
• Study design: Repeated cross-sectional surveys in communities and schools to monitor the Schistosoma haematobium prevalence and infection intensity in the study population. (Screening)
• Phase: Not Applicable

Countries of recruitment

Tanzania

Contacts

• Name: Stefanie Knopp

Key inclusion & exclusion criteria

Inclusion criteria:
1. Children attending the selected nurseries and schools
2. Adolescents or adults aged =13 years from the selected shehias, including pregnant women, only one adolescent and/or adult per household eligible
3. Submitted informed consent form (ICF) signed by a parent or legal guardian in case of participating children and adolescents, or signed by the participant in case of participating adults
4. Able to provide one urine sample with sufficient volume to perform diagnostic tests

Exclusion criteria: Does not meet inclusion criteria

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Schistosoma haematobium infections (urogenital schistosomiasis)
Infections and Infestations
Schistosoma haematobium, urogenital schistosomiasis, bilharziasis

Intervention(s)

The S. haematobium prevalence will be determined annually (2018, 2019, 2020, 2021) in cross-sectional surveys conducted in schools and communities of the study area.

Mass drug administration with praziquantel (40 mg/kg) is carried out as part of the routine interventions of the Neglected Tropical Diseases Programme (NTD) of the Zanzibar Ministry of Health at least once per year. In community-based treatment, trained drug distributors use a door-to-door approach to provide praziquantel to all community members aged >3 years that did not receive praziquantel in the same treatment round via school-based treatment, and are not severely sick. In school-based treatment, trained teachers provide directly-observed praziquantel treatment to the children attending school on the day of treatment. Community drug distributors and teachers are supervised by the staff of the NTD Programme.

Primary Outcome(s)

Current primary outcome measure as of 27/07/2020:
Number of S. haematobium infected individuals detected by the urine filtration method (detecting S. haematobium eggs in 10 ml urine) and reagent strip method (Hemastix; detecting microhaematuria in urine) applied on a single urine sample per participant in each annual cross-sectional survey in 2018, 2019, 2020, and 2021

Previous primary outcome measure:
Number of S. haematobium infected individuals detected by the urine filtration method (detecting S. haematobium eggs in 10 ml urine) and reagent strip method (Hemastix; detecting microhaematuria in urine) applied on a single urine sample per participant in each cross-sectional survey at 0, 1, 2, and 3 years

Secondary Outcome(s)

Current secondary outcome measures as of 27/07/2020:
1. Impact of mass drug administration (MDA) with praziquantel (40 mg/kg) over time measured in 2018, 2019, 2020, and 2021 during the annual cross-sectional school-based and community-based surveys using:
1.1. S. haematobium prevalence measured by urine filtration (S. haematobium egg absence/presence in 10 ml urine) and measured by reagent strips to assess microhaematuria absence/presence
1.2. S. haematobium infection intensity measured by urine filtration (S. haematobium egg counts in 10 ml urine)
2. Age-prevalence distribution by age and stratified by sex, measured by urine filtration and reagent strips, sex and age will be recorded on enrolment and in 2018, 2019, 2020, and 2021 during the annual cross-sectional school-based and community-based surveys
3. Treatment coverage and compliance of MDA with praziquantel (40 mg/kg) preceding the cross-sectional survey, determined with questionnaires in annual cross-sectional surveys (coverage is defined as the percentage of those queried receiving praziquantel tablets during MDA, and compliance is defined as the percentage of those queried swallowing praziquantel tablets in the dose supplied during MDA) in 2018, 2019, 2020, and 2021
4. Risk factors for S. haematobium infection determined with questionnaires (query the use of natural open freshwater bodies for washing, bathing and household chores, travel, location of residence and demographic factors) during annual cross-sectional surveys in 2018, 2019, 2020, and 2021

Previous secondary outcome measures:
1. Impact of mass drug administration (MDA) with praziquantel (40 mg/kg) over time measured at 0, 1, 2 and 3 years during the annual cross-sectional school-based and community-based surveys using:
1.1. S. haematobium prevalence measured by urine filtration (S. haematobium egg absence/presence in 10 ml urine) and measured by reagent strips to assess microhaematuria absence/presence
1.2. S. haematobium infection intensity measured by urine filtration (S. haematobium egg counts in 10 ml urine)
2. Age-prevalence distribution by age and stratified by sex, measured by urine filtration and reagent strips, sex and age will be recorded on enrolment and at 0, 1, 2 and 3 years during the annual cross-sectional school-based and community-based surveys
3. Treatment coverage and compliance of MDA with praziquantel (40 mg/kg) preceding the cross-sectional survey, determined with questionnaires in annual cross-sectional surveys (coverage is defined as the percentage of those queried receiving praziquantel tablets during MDA, and compliance is defined as the percentage of those queried swallowing praziquantel tablets in the dose supplied during MDA) at 0, 1, 2 and 3 years
4. Risk factors for S. haematobium infection determined with questionnaires (query the use of natural open freshwater bodies for washing, bathing and household chores, travel, location of residence and demographic factors) during annual cross-sectional surveys at 0, 1, 2 and 3 years

Secondary ID(s)

Nil known

Version 1.0 (03.06.2019)

Source(s) of Monetary Support

Bill and Melinda Gates Foundation

Ethics review

Status:
Approval date:
Contact:

1. Approved 01/02/2017, Zanzibar Medical Research and Ethics Committee (ZAMREC) (Ministry of Health Zanzibar, PO Box 236, Vuga, Zanzibar, United Republic of Tanzania), Ref: ZAMREC 0003/SEPTEMBER/011 2. Approved April 20/04/2018, Zanzibar Medical Research and Ethics Committee (ZAMREC) (Ministry of Health Zanzibar, PO Box 236, Vuga, Zanzibar, United Republic of Tanzania), Ref: NO.ZAMREC/0001/FEBRUARY/18 3. Approved 12/06/2019, Zanzibar H

Results

• Date Completed: 31/12/2022