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

• Register: ISRCTN
• Last refreshed on: 24 October 2022
• Main ID: ISRCTN48837681
• Date of registration: 05/09/2012
• Prospective Registration: No
• Primary sponsor: Natural History Museum (UK)
• Public title: Study and implementation of urogenital schistosomiasis elimination in Zanzibar (Unguja and Pemba islands)
• Scientific title: Study and implementation of urogenital schistosomiasis elimination in Zanzibar (Unguja and Pemba islands) using an integrated multidisciplinary approach
• Date of first enrolment: 01/11/2011
• Target sample size: 72000
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN48837681
• Study type: Interventional
• Study design: Randomised intervention trial with three study arms (Treatment)
• Phase: Not Applicable

Countries of recruitment

England, Switzerland, Tanzania, United Kingdom

Contacts

• Name: David Rollinson

Key inclusion & exclusion criteria

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)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Schistosoma haematobium infections
Infections and Infestations
Schistosomiasis due to Schistosoma haematobium [urinary schistosomiasis]

Intervention(s)

The study will be implemented in 45 shehias in both Unguja and Pemba. Among the 45 shehias on each island 15 were randomly assigned to one of the following three intervention arms:
1. Treatment per the National Plan of the Zanzibar Ministry of Health (twice yearly preventive chemotherapy with praziquantel, including social mobilization and education)
2. Treatment per the National Plan plus snail control
3. Treatment per the National Plan plus intensive behaviour change interventions

Primary Outcome(s)

Current primary outcome measure as of 25/03/2019:
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)

Previous primary outcome measure:
Elimination of urogenital schistosomiasis in Unguja and reduction of the S. haematobium prevalence <10% in Pemba after 5 years of interventions

Secondary Outcome(s)

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
2. Impact of niclosamide on snail populations, schistosome transmission and reinfection of the Zanzibari population
3. Changes in the behaviour of the human population associated with parasite transmission
4. Sensitivity and specificity of novel diagnostic methods

Secondary ID(s)

N/A

Nil known

Source(s) of Monetary Support

University of Georgia Research Foundation Inc. (USA), World Health Organization (Switzerland), The Schistosomiasis Control Initiative (UK), Bayer S.A.S. (France)

Ethics review

Status:
Approval date:
Contact:

1. Ethikkommission beider Basel, Switzerland, 08/08/2011, ref: 236/11 2. Zanzibar Medical Research Ethical Committee of the Zanzibar Ministry of Health (ZAMREC, United Republic of Tanzania, 29/09/2011, ref: ZAMREC/0003/Sept/011 3. Institutional Review Board of the University of Georgia, USA, 27/10/2011, ref: 2012-10138-0

Results

• Results available: Yes
• Date Completed: 31/12/2017