Gaining and sustaining control of Schistosomiasis in Cabo Delgado, Mozambique where the starting prevalence is greater than 25%

ISRCTN	ISRCTN14117624
DOI	https://doi.org/10.1186/ISRCTN14117624
Protocol serial number	N/A
Sponsor	University of Georgia Research Foundation / SCORE (USA)
Funder	Bill and Melinda Gates Foundation

Submission date: 14/12/2015
Registration date: 14/12/2015
Last edited: 20/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Josefo Ferro
Public

Catholic University of Mozambique
Marques Do Several
Beira
960
Mozambique

Phone	+258 (0)23 312 835
Email	josefoferro@yahoo.com.br

Study information

Primary study design	Interventional
Study design	Multi-centre randomized intervention trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	Sm2 Mozambique
Study objectives	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(s)	Ministry Of Health, National Institute of Health, National Committee of BioEthics, Ref: 235/CNBS/10
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Praziquantel
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2015

Eligibility

Participant type(s)
Age group	Mixed
Sex	All
Target sample size at registration	105000
Key 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
Key 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)
Date of first enrolment	02/11/2011
Date of final enrolment	30/11/2015

Locations

Countries of recruitment

Mozambique

Study participating centre

Catholic University of Mozambique

Beira
960
Mozambique

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/11/2018		Yes	No
Protocol article	protocol and baseline data	26/05/2016		Yes	No
Interim results article	Protocol and baseline data for a multi-year cohort study of the effects of different mass drug treatment approaches on functional morbidities from schistosomiasis in four African countries	29/09/2017	20/01/2023	Yes	No
Other publications	Challenges in Protocol Development and Interpretation of the Schistosomiasis Consortium for Operational Research and Evaluation Intervention Studies	12/05/2020	20/01/2023	Yes	No
Other publications	Impact of Different Mass Drug Administration Strategies for Gaining and Sustaining Control of Schistosoma mansoni and Schistosoma haematobium Infection in Africa	12/05/2020	20/01/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/01/2023: Publication references added.
16/11/2018: Publication reference added.
31/05/2016: Publication reference added.