Condition category
Infections and Infestations
Date applied
14/12/2015
Date assigned
16/12/2015
Last edited
31/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Schistosomiasis is a long-term (chronic) infection caused by parasites that live in fresh water (for example, rivers and lakes) in tropical and subtropical countries, with over 90% of cases occurring in Africa. It can range from very mild (fever, skin rash, coughing) to more serious (passing blood in diarrhoea or urine, vomiting blood, stomach pains, paralysis of the legs). The World Health Organisation wants to treat 75% of the population who are at risk of a schistosomiasis infection by 2020 and preventive treatment (chemotherapy) will increase massively as a result. In Kenya, the main parasites which cause schistosomiasis (Schistosoma mansoni and Schistosoma haematobium) are common, and so many people suffer from schistosomiasis affecting the urinary and genital organs (intestinal or urogenital schistosomiasis). Before this study, no large-scale preventive chemotherapy programme had been set up in this area. The aim of this study is to use Mass Drug Administration (MDA) in schools and the community in Niger in order to find out the best treatment regimen for the lowest cost.

Who can participate?
First-year adult students in years 1 and 5, and school children aged between 9 and 12 who attend participating schools in Kenya.

What does the study involve?
Each school which is taking part in the study is randomly allocated to one of six groups. In the first group, school-age children and adults are treated with praziquantel once a year for the 4 years of the study. In the second group, school-age children and adults are treated once a year for the first two years of the study and then treated twice a year in years 3 and 4. In the third group, school-age children only are treated once a year for the 4 years of the study. In the fourth group, school-age children only are treated once a year for the first two years of the study and then treated twice a year in years 3 and 4. In the fifth group, school-age children only are treated in year one, on holiday (no treatment) in year 2 of the study and receive treatment once each year in years 3 and 4. In the sixth group, school-age children only are treated once in year 1, on holiday in year 2, and receive 2 treatments every 6 months in years 3 and 4. Throughout the study period, urine samples are taken from participants in order to test for infection.

What are the possible benefits and risks of participating?
There are no risks from the collection of urine for testing for infection. If a person is infected, then they will benefit from receiving treatment. The expected benefit to the village is that the force of transmission will be reduced by the medication provided thus reducing reinfection rates and illness.

Where is the study run from?
RISEAL Niger (Niger)

When is the study starting and how long is it expected to run for?
March 2010 to June 2016

Who is funding the study?
Bill and Melinda Gates Foundation (USA)

Who is the main contact?
Dr Amadou Garba

Trial website

Contact information

Type

Public

Primary contact

Dr Amadou Garba

ORCID ID

Contact details

RISEAL Niger
333 Avenue of Zarmakoye
Box / BP: 13 724
Niamey
8000
Niger

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Community-wide and school-based annual treatment compared to community-wide and school-based double treatment in controlling Schistosoma haematobium

Acronym

Sh Niger

Study hypothesis

The implementation of preventive chemotherapy with the anti-schistosomal drug praziquantel in school-aged children (exclusion of children <5 years) and in adults randomized to study arms either receiving treatment twice a year will more cost-effectively gain and sustain the control of prevalence and intensity due to Schistosoma haematobium infection versus treatment once a year with treatment implemented in schools and community venues.

Ethics approval

1. National Advisory Committee on Ethics, 22/07/2010, ref: No.011/2014/CCNE
2. Imperial College Research Ethics Committee, 30/07/2010, ref: ICREC_8_2_2

Study design

Community and school-based randomized parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel 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

Schistosomiasis

Intervention

In a first step, in-depth parasitological surveys are carried out to identify 225 schools where the prevalence of S. haematobium (i.e. number of infections) amongst schoolchildren is greater than 10%.

Each school is then randomly allocated into one of six groups, who receive their praciquantel in different treatment regimens. In all groups, the praziquantel is delivered by trained teachers in schools and by drug distributors in the community MDA venues.

Group 1: School-age children and adults in this group are treated with praziquantel once a year for the 4 years of the study.
Group 2: School-age children and adults are treated once a year for the first two years of the study and then treated twice a year in years 3 and 4.
Group 3: School-age children only are treated once a year for all 4 years.
Group 4: School-age children only are treated once a year for the first two years and then twice a year in years 3 and 4.
Group 5: School-age children are treated in year one, on holiday (no treatment) in year 2 of the study and receive treatment once each year in years 3 and 4.
Group 6: School-age children receive treatment once in year 1, on holiday in year 2, and receive 2 treatments every 6 months in years 3 and 4.

Each Year the follow-up includes additional prevalence and intensity testing in the 225 schools, which includes all study Arms. This is collection of urine from each participant and testing that specimen for presence or absence of S. haematobium eggs.

Intervention type

Drug

Phase

Not Applicable

Drug names

Praziquantel

Primary outcome measures

MDA strategy that is able to reduce S. haematobium infection measured by change in prevalence and intensity of Schistosoma haematobium infection in 9- to 12-year-old children is measured at baseline, 1, 2, 3 and 4 years by filtering the urine and preparing slide for microscopic exam. In addition, the urine is observed to see if hematuria visible.

Secondary outcome measures

1. Prevalence and intensity of S. haematobium infections in 9- to-12- year-old schoolchildren is measured at baseline, 1, 2, 3 and 4 years using urinalysis
2. Prevalence and intensity of S. haematobium infections in first-year schoolchildren is measured at baseline, 1, 2, 3 and 4 years using urinalysis
3. Identification of S. haematobium risk factors is measured by collecting village inventory data about water, sanitation, hygiene and water body contact at baseline, 1, 2, 3 and 4 years
5. Mapping and prediction of the distribution S. haematobium in Niger is measured by collecting and using GIS coordinates of schools, water bodies and water and sanitation infrastructure at baseline, 1, 2, 3 and 4 years

Overall trial start date

10/03/2010

Overall trial end date

30/06/2016

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. Written informed consent signed by parents or legal guardians of the schoolchildren
4. Oral assent from schoolchildren
5. At least one urine sample provided from 9- to 12- years- old children each study year
6. At least one urine sample provided from first-year students and adults in years 1 and 5

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

145,000

Participant exclusion criteria

1. Children not aged 9-12 years (in years 2, 3 and 4)
2. Adults in Years 2, 3 and 4
2. Children under 9 in Years 2, 3, 4
3. No written informed consent by parents or legal guardians of schoolchildren
4. No oral assent given by schoolchildren
5. 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)

Recruitment start date

01/01/2012

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Niger

Trial participating centre

RISEAL Niger
333 Avenue of Zarmakoye
Niamey
8000
Niger

Sponsor information

Organisation

University of Georgia Research Foundation / SCORE

Sponsor details

145Coverdell Center
500 DW Brooks Drive
Athens
30602
United States of America
+1 706 542 1879
ccamp@uga.edu

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation

Alternative name(s)

Bill & Melinda Gates Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication of protocol, baseline results and final results in peer reviewed journals.

Intention to publish date

29/02/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol and baseline data in: http://www.ncbi.nlm.nih.gov/pubmed/27230666

Publication citations

Additional files

Editorial Notes

31/05/2016: Publication reference added.