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
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 measure
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 (if study stopped)
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)
बिल एंड मिलिंडा गेट्स फाउंडेशन, Bill & Melinda Gates Foundation, Gates Foundation, 比尔及梅琳达·盖茨基金会, BMGF, B&MGF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
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
Basic results (scientific)
Publication list
2016 protocol and baseline data in: http://www.ncbi.nlm.nih.gov/pubmed/27230666