Schistosoma Mansoni in Mwanza Region, Tanzania

Not Applicable

Completed

• Conditions: Schistosoma Mansoni
• Interventions: Drug: Praziquantel

• Registration Number: NCT02162875
• Lead Sponsor: DBL -Institute for Health Research and Development

Brief Summary

The objective of this study is to determine the strategy for mass drug administration (MDA) which provides the greatest reductions in prevalence and intensity of Schistosoma mansoni in school-aged children after 4 years of intervention.

Detailed Description

Intestinal schistosomiasis is caused by the blood-dwelling flatworm Schistosoma mansoni. Despite the increasing focus on the use of praziquantel against schistosomiasis infections for the last three decades many areas in Sub-Saharan Africa still have high prevalences and intensities of schistosomiasis especially among school-age children. This is true for the area of Mwanza Region of Tanzania adjacent to Lake Victoria. The study is a six arm study and includes 150 communities (25 in each arm). From each community 100 school children (aged 9-12 years), 100 first year students (aged 7-8 years) and 50 adults (aged 20-55 years) are included, diagnosed and treated with praziquantel using strategies composing of a mixture of community wide treatment (CWT), school-based treatment (SBT) and years without treatment (-T). The 100 school children provided stool specimens on three consecutive days, while the 100 first year students and 50 adults with few exceptions only provided one specimen. The treatment strategies during the 4 years for the different arms are as follows: Arm 1: CWT, CWT, CWT, CWT; Arm 2: CWT, CWT, SBT, SBT; Arm 3: CWT, CWT -T, -T; Arm 4: SBT, SBT, SBT, SBT; Arm 5: SBT, SBT, -T, -T; Arm 6: SBT, -T, SBT, -T.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2014-05-26
• Study First Submitted QC: 2014-06-12
• Study First Posted: 2014-06-13
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37500

Inclusion Criteria

-All school children and adults who consent to participate can be included

Exclusion Criteria

-Those not consenting or with any chronic disease not related to schistosomiasis will be excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MDA once a year SBT	Praziquantel	Treatment with praziquantel as above given as 4 years of SBT
Praziquantel every second year CWT	Praziquantel	Treatment with praziquantel given every second year as CWT
MDA once a year	Praziquantel	Community wide treatment (CWT) once a year for four years with single dose praziquantel 40mg/kg
MDA 2nd year CWT follwed by 2 years SBT	Praziquantel	Treatment with praziquantel as arm 1 given by two years of community wide treatment (CWT) followed by two years of school-based treatment (SBT)
MDA as SBT 1year and 1 year without MDA	Praziquantel	Treatment with praziquantel given as one years of SBT alternating with one year without treatment
MDA given for 2 years as SBT	Praziquantel	Treatment with praziquantel as above given for 2 years as SBT followed by 2 years without MDA

Primary Outcome Measures

Name	Time	Method
Effect of Mass drug administration on prevalence and intensity of Schistosoma mansoni among children and adults	May -October 2016 (5 months)	Prevalence and intensity of Schistosoma mansoni

Secondary Outcome Measures

Name	Time	Method
Mass drug administration coverage	May -October 2016 (5 months)	Coverage of treatment

Trial Locations

Locations (1)

National Institute for Mediacal Research; 🇹🇿 Mwanza, Lake Region, Tanzania