Condition category
Infections and Infestations
Date applied
13/12/2015
Date assigned
14/12/2015
Last edited
31/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 Kenya, 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. mansoni 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?
Kenya Medical Research Institute

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

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

Who is the main contact?
Dr Pauline NM Mwinzi
pmwinzi65@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Pauline Mwinzi

ORCID ID

Contact details

Kenya Medical Research Institute
PO Box 1578
Kisumu
40100
Kenya
+254 (0)721 308 588
Pmwinzi@kemri.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of school and community-based mass drug administration delivery strategies for control of Schistosoma mansoni infections in western Kenya in areas with >25% prevalence: a multi-centre randomized intervention trial

Acronym

Sm2

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 mansoni infection in areas with high endemicity (prevalence: >25%) in Kenya than the implementation of four yearly rounds of annual chemotherapy in school-aged children.

Ethics approval

Kenya Medical Research Institute, 01/09/2010, ref: KEMRI/RES/7/3/1

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

Schistosomiasis

Intervention

In the first step, in-depth parasitological surveys are carried out to identify 150 schools where the prevalence of S. mansoni (i.e., number of infections) amongst schoolchildren is greater than 24%. Prevalence during this eligibility step is measured using Kato-Katz thick smears 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. mansoni 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 measures

Identification of the most cost-effective strategy that is able to reduce S. mansoni infection from high prevalence levels, measured by change in prevalence and intensity of Schistosoma mansoni infection in 9- to 12-year-old children over the four years of intervention.

Secondary outcome measures

1. Prevalence and intensity of S. mansoni infections in 9- to-12- year-old schoolchildren, using Kato-Katz thick smears
2. Prevalence and intensity of S. mansoni infections in first-year schoolchildren, using Kato-Katz thick smears
3. Control of morbidity due to S. mansoni (reduction of the prevalence to <10%) in the 150 schools
4. Identification of S. mansoni risk factors
5. Mapping and prediction of the distribution of S. mansoni in Western Kenya

Measured by changes in force of transmission, as assessed by infection prevalence and intensity of S. mansoni in first-year students and adults.

Overall trial start date

01/12/2010

Overall trial end date

31/12/2016

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 stool sample provided over three consecutive days from 9- to 12- year-old children each study year
6. At least one stool 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
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 stool 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

01/12/2010

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Kenya

Trial participating centre

Kenya Medical Research Institute
PO Box 1578
Kisumu
40100
Kenya

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

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Mid-term results; multiple papers on behavioural, epidemiological, and costing, and final prevalence and intensity results. Additional policy and programme considerations to assist NTD Programme Managers.

Intention to publish date

31/03/2016

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.