Plain English Summary
Background and study aims
Schistosomiasis is a chronic (long term) infection caused by parasites that live in fresh water (for example, rivers and lakes) in tropical and subtropical countries. Symptoms of the disease vary widely and can be fairly mild (fever, skin rash, coughing) or more serious (passing blood in diarrhoea or urine, vomiting blood, stomach pains, paralysis of the legs). Over 90% of cases occur in Africa. The World Health Organisation wants to treat 75% of the population at risk of schistosomiasis infection by 2020 and preventive treatment (chemotherapy) will increase massively as a result. In Mozambique, where both S. mansoni and S. haematobium are endemic and many people suffer from intestinal or urogenital schistosomiasis (schistosomiasis affecting the urinary and genital organs) no large-scale preventive chemotherapy programme had been set up before the start of this study. We want to investigate which combination of annual praziquantel treatments (given in schools or in communities) and 'drug holidays' (when no treatment is given) is the most successful for the lowest cost.
Who can participate?
Schoolchildren aged 9-12 years and first-year students in years 1 and 5 attending the selected schools.
What does the study involve?
Participating schools are randomly allocated into one of six groups.
Group 1: School-age children and adults are treated with praziquantel once a year for the 4 years of the study
Group 2: School-age children and adults are treated for the first two years of the study and only school-age children are treated for the last two years
Group 3: School-age children and adults are treated for the first two years of the study and receive no treatment in the last two years
Group 4: School-age children are treated every year
Group 5: School-age children are treated for the first two years
Group 6: School-age children are treated for the first year and the third year
Any changes in the prevalence and intensity (severity of infection) of S. haematobium infection are measured over the 4 years of the study.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Catholic University of Mozambique
When is the study starting and how long is it expected to run for?
November 2011 to November 2015
Who is funding the study?
Bill and Melinda Gates Foundation (USA)
Who is the main contact?
Dr Josef Oferro
josefoferro@yahoo.com.br
Trial website
Contact information
Type
Public
Primary contact
Dr Josefo Ferro
ORCID ID
Contact details
Catholic University of Mozambique
Marques Do Several
Beira
960
Mozambique
+258 (0)23 312 835
josefoferro@yahoo.com.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Gaining and sustaining control of Schistosomiasis in Cabo Delgado, Mozambique where the starting prevalence is greater than 25%: a multi-centre randomized intervention trial
Acronym
Sm2 Mozambique
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 every year, or alternating with drug holidays in years 2 and 4 or drug holidays in years 3 and 4, will more cost-effectively gain the control of prevalence and morbidity due to Schistosoma haematobium infection in areas with high endemicity (prevalence: >25%) in Mozambique than the implementation of four yearly rounds of annual chemotherapy in school-aged children.
Ethics approval
Ministry Of Health, National Institute of Health, National Committee of BioEthics, Ref: 235/CNBS/10
Study design
Multi-centre randomized intervention trial
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
Neglected Tropical Diseases, Schistosomiasis
Intervention
In the first step, in-depth parasitological surveys are carried out to identify 150 schools where the prevalence of S. haematobium (i.e., number of infections) amongst schoolchildren is greater than 24%. Prevalence during this eligibility step is measured by testing urine using urine dipsticks from 50 children aged 13-14 years per locality.
Each school is then randomly allocated into one of six groups.
Group 1: School-age children and adults are treated with praziquantel once a year for the 4 years of the study
Group 2: School-age children and adults are treated for the first two years of the study and only school-age children are treated for the last two years
Group 3: School-age children and adults are treated for the first two years of the study and receive no treatment in the last two years
Group 4: School-age children are treated every year
Group 5: School-age children are treated for the first two years
Group 6: School-age children are treated for the first year and the third year
Three days of consecutive parasitological surveys are carried out before each treatment to assess any changes to the prevalence and intensity (severity of infection) of S. haematobium infection over time. The praziquantel is administered by trained teachers to all children aged 5-15 years in schools and by drug distributors in the community MDA venues.
Intervention type
Drug
Phase
Not Applicable
Drug names
Praziquantel
Primary outcome measure
Identification of the most cost-effective strategy that is able to reduce S. haematobium infection from high prevalence levels measured by change in prevalence and intensity of Schistosoma haematobium infection in 9- to 12-year-old children over the four years of intervention.
Secondary outcome measures
1. Prevalence and intensity of S. haematobium infections in 9- to-12- year-old schoolchildren.
2. Prevalence and intensity of S. haematobium infections in first-year schoolchildren.
3. Control of morbidity due to S. haematobium (reduction of the prevalence to <10%) in the 150 schools
4. Identification of S. haematobium risk factors
5. Mapping and prediction of the distribution S. haematobium in Cabo Delgado Region, Mozambique.
Measured by changes in force of transmission, as assessed by infection prevalence and intensity of S. haematobium in first-year students and adults.
Overall trial start date
02/11/2011
Overall trial end date
31/12/2015
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 over three consecutive days from 9- to 12-year-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
105,000
Participant exclusion criteria
1. Children not aged 9-12 years (in years 2, 3 and 4)
2. Adults in Years 2, 3 and 4
3. Children under 9 in Years 2, 3, 4
4. No written informed consent by parents or legal guardians of schoolchildren
5. No oral assent given by schoolchildren
6. 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
02/11/2011
Recruitment end date
30/11/2015
Locations
Countries of recruitment
Mozambique
Trial participating centre
Catholic University of Mozambique
Beira
960
Mozambique
Sponsor information
Organisation
University of Georgia Research Foundation / SCORE (USA)
Sponsor details
145 Coverdell Center
500 DW Brooks Drive
Athens
Georgia
30602
United States of America
+1 (0)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
Trusts, charities, foundations (both publically funded and privately funded)
Location
United States of America
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
1. 2016 protocol and baseline data in: http://www.ncbi.nlm.nih.gov/pubmed/27230666
2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30439945