Condition category
Infections and Infestations
Date applied
28/08/2012
Date assigned
05/09/2012
Last edited
17/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Schistosomiasis is an infection caused by parasites that live in freshwater snails. It continues to be a major public health problem in many developing countries. However, illness due to schistosomiasis has been greatly reduced in some parts of the world, including Zanzibar. Over the next 3-5 years, the whole at-risk population on Unguja and Pemba islands will be given the drug praziquantel twice a year to treat schistosomiasis infection. Strategies to control the snails that carry the parasites and also to change people’s behaviour will be carried out in selected communities. We will compare the impact and outcome of the these three interventions to provide evidence for decisions about schistosomiasis elimination not only for the Zanzibar, but also for other settings in Africa and elsewhere.

Who can participate?
45 randomly selected communities on Unguja and Pemba islands.

What does the study involve?
The communities are randomly allocated to one of three groups. All three groups will be treated with praziquantel. One of the groups receives no additional treatment. The second group receives niclosamide (a pesticide against snails) twice-yearly to reduce the population of snails that carries the parasites. The third group receives interventions to trigger behaviour change. Changes in knowledge, attitudes and practices will be assessed annually through focus group discussions and in-depth interviews with schoolchildren, teachers, parents and community leaders. Changes in the levels of infection are assessed annually and outcomes compared between the three groups. Changes in the health system, water and sanitation infrastructure will be annually tracked by interviews with community leaders. Additional issues potentially impacting on study outcomes and all incurring costs will be monitored and recorded.

What are the possible benefits and risks of participating?
The direct benefit to the whole at-risk population in Zanzibar including our study participants will be reduced illness caused by schistosomiasis infections. Praziquantel is generally well tolerated. Side effects are typically mild and short-lived and do not require treatment. The following side effects may be observed: discomfort, headache, dizziness, feeling sick, rise in temperature and, rarely, hives.

Where is the study run from?
The study is jointly run by :
Natural History Museum London (UK)
Swiss Tropical and Public Health Institute (Switzerland)
Centers for Disease Control and Prevention (USA)
Helminth Control Laboratory Unguja of the Zanzibar Ministry of Health and the Public Health Laboratory-Ivo de Carneri in Pemba (Tanzania)

When is the study starting and how long is it expected to run for?
November 2011 to April 2016.

Who is funding the study?
SCORE at the University of Georgia Research Foundation (UGARF) through the Bill and Melinda Gates Foundation (USA).

Who is the main contact?
Prof. David Rollinson
d.rollinson@nhm.ac.uk

Trial website

http://score.uga.edu/Elimination.html

Contact information

Type

Scientific

Primary contact

Prof David Rollinson

ORCID ID

Contact details

Natural History Museum
Cromwell Road
London
SW7 5BD
United Kingdom
+44 (0)20 7942 5181
d.rollinson@nhm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Study and implementation of urogenital schistosomiasis elimination in Zanzibar (Unguja and Pemba islands) using an integrated multidisciplinary approach.

Acronym

Study hypothesis

Applying periodic treatment with praziquantel to the whole eligible population (exclusion of children <3 years, pregnant women and severely sick people) at risk of S. haematobium, plus snail control using a molluscicide (niclosamide) and environmental management, plus behaviour change interventions will result in:
1. Elimination of schistosomiasis as a public health problem in 3 years and interruption of transmission in 5 years in Unguja
2. Control of schistosomiasis (prevalence <10%) in 3 years and elimination of schistosomiasis as a public health problem in 5 years in Pemba

Ethics approval

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

Study design

Randomised intervention trial with three study arms

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Schistosoma haematobium infections.

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/11/2011

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

72000

Participant 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)

Recruitment start date

01/11/2011

Recruitment end date

30/04/2016

Locations

Countries of recruitment

Tanzania

Trial participating centre

Natural History Museum
London
SW7 5BD
United Kingdom

Sponsor information

Organisation

Natural History Museum (UK)

Sponsor details

Cromwell Road
London
SW7 5BD
United Kingdom

Sponsor type

Research organisation

Website

http://www.nhm.ac.uk/

Funders

Funder type

University/education

Funder name

University of Georgia Research Foundation Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

World Health Organization (Switzerland)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

Funder name

The Schistosomiasis Control Initiative (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bayer S.A.S. (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes