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

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.

Study Overview

• Status: Completed
• Conditions: Schistosoma Mansoni
• Intervention / Treatment: Drug: Praziquantel

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 Type: Interventional
• Enrollment (Anticipated): 37500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Lake Region
    • Mwanza, Lake Region, Tanzania
      • National Institute for Mediacal Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of different treatment arm	Cost of different treatment arm	May-October 2016 (5 months)

Collaborators and Investigators

• Sponsor: DBL -Institute for Health Research and Development
• Investigators: Principal Investigator: Safari Kinung'hi, PhD, National Institute for Medical Research, Mwanza Research Centre

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 26, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: treatment; adults; Schistosoma mansoni; school children
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiparasitic Agents; Anthelmintics; Praziquantel
• Other Study ID Numbers: TAN-score; BMGF (Other Grant/Funding Number: OPP1032239)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO