Schistosoma Mansoni in Mwanza Region, Tanzania
SCORE_PAR
Parasitologic Impact of Different Mass Drug Administration Strategies Against Schistosoma Mansoni in Endemic Areas of Mwanza Region, Tanzania, Where Prevalence is 25% or Above
2 other identifiers
interventional
37,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 26, 2014
CompletedFirst Posted
Study publicly available on registry
June 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFebruary 10, 2017
February 1, 2017
5.8 years
May 26, 2014
February 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Mass drug administration coverage
May -October 2016 (5 months)
Other Outcomes (1)
Cost of different treatment arm
May-October 2016 (5 months)
Study Arms (6)
MDA once a year
EXPERIMENTALCommunity wide treatment (CWT) once a year for four years with single dose praziquantel 40mg/kg
MDA 2nd year CWT follwed by 2 years SBT
EXPERIMENTALTreatment with praziquantel as arm 1 given by two years of community wide treatment (CWT) followed by two years of school-based treatment (SBT)
Praziquantel every second year CWT
EXPERIMENTALTreatment with praziquantel given every second year as CWT
MDA once a year SBT
EXPERIMENTALTreatment with praziquantel as above given as 4 years of SBT
MDA given for 2 years as SBT
EXPERIMENTALTreatment with praziquantel as above given for 2 years as SBT followed by 2 years without MDA
MDA as SBT 1year and 1 year without MDA
EXPERIMENTALTreatment with praziquantel given as one years of SBT alternating with one year without treatment
Interventions
Six different treatment strategies with praziquantel
Eligibility Criteria
You may qualify if:
- All school children and adults who consent to participate can be included
You may not qualify if:
- Those not consenting or with any chronic disease not related to schistosomiasis will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute for Mediacal Research
Mwanza, Kagera, Tanzania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Safari Kinung'hi, PhD
National Institute for Medical Research, Mwanza Research Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 26, 2014
First Posted
June 13, 2014
Study Start
March 1, 2011
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
February 10, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share