Schistosoma Mansoni in Mwanza Region, Tanzania

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parasitologic Impact of Different Mass Drug Administration Strategies Against Schistosoma Mansoni in Endemic Areas of Mwanza Region, Tanzania, Where Prevalence is 25% or Above

Conditions
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Schistosoma Mansoni

Intervention / Treatment
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* Drug: Praziquantel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDA once a year<br>Community wide treatment (CWT) once a year for four years with single dose praziquantel 40mg/kg | Drug: Praziquantel<br>* Six different treatment strategies with praziquantel<br>* Other names: no other drugs;|
| Experimental: MDA 2nd year CWT follwed by 2 years SBT<br>Treatment with praziquantel as arm 1 given by two years of community wide treatment (CWT) followed by two years of school-based treatment (SBT) | Drug: Praziquantel<br>* Six different treatment strategies with praziquantel<br>* Other names: no other drugs;|
| Experimental: Praziquantel every second year CWT<br>Treatment with praziquantel given every second year as CWT | Drug: Praziquantel<br>* Six different treatment strategies with praziquantel<br>* Other names: no other drugs;|
| Experimental: MDA once a year SBT<br>Treatment with praziquantel as above given as 4 years of SBT | Drug: Praziquantel<br>* Six different treatment strategies with praziquantel<br>* Other names: no other drugs;|
| Experimental: MDA given for 2 years as SBT<br>Treatment with praziquantel as above given for 2 years as SBT followed by 2 years without MDA | Drug: Praziquantel<br>* Six different treatment strategies with praziquantel<br>* Other names: no other drugs;|
| Experimental: MDA as SBT 1year and 1 year without MDA<br>Treatment with praziquantel given as one years of SBT alternating with one year without treatment | Drug: Praziquantel<br>* Six different treatment strategies with praziquantel<br>* Other names: no other drugs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Mass drug administration on prevalence and intensity of Schistosoma mansoni among children and adults | Prevalence and intensity of Schistosoma mansoni | May -October 2016 (5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass drug administration coverage | Coverage of treatment | May -October 2016 (5 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schistosoma mansoni, treatment, school children, adults