- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06312462
Health Education Model Led by Community Health Volunteers.
A Survey on the Knowledge, Attitudes, and Practices of Students Regarding Schistosomiasis Through a Health Education Model Led by Community Health Volunteers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main questions it aims to answer are:
Conducting a survey to understand the current knowledge levels, attitudes, and relevant health behaviors of Pemba Island students towards schistosomiasis.
Performing qualitative research to analyze the factors influencing students' knowledge, attitudes, and behaviors related to schistosomiasis, as well as observing the facilitators and barriers to conducting health education among student groups, in order to provide a scientific basis for targeted intervention measures.
Testing the effectiveness of establishing a widely applicable community health volunteer model in the Zanzibar region and exploring the feasibility of promoting this model in other regions of Africa, thereby providing insights and references for global schistosomiasis prevention and control efforts.
Participants will select fourth and fifth grade students from two schools located in high-risk schistosomiasis prevalence areas on Pemba Island, with Kilindi Primary School as the intervention group and Shumba Viamboni or Chambani primary school as the control group from Feb 2024 to Feb 2025. Apart from the KAP survey, urine samples will be collected from students three times at least and the prevalence confirmed to compare the effectiveness of the two groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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CharkChark
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Pemba, CharkChark, Tanzania, P.O.BOX 98
- Neglected tropical diseases in Pemba
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals whose grades fall within the scope of the survey Students who have not received health education intervention on schistosomiasis conducted by community health volunteers Students or parents who agree to sign informed consent and participate in the study Students residing in schistosomiasis-endemic areas
Exclusion Criteria:
- Students whose grades are not within the scope of the survey Students who have already received health education intervention on schistosomiasis Students or parents who refuse to sign informed consent or participate in the study Students who have been diagnosed with other serious illnesses.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: CHVs Intervention group
A group of students who receive schistosomiasis health education intervention led by community health volunteers.
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In the intervention group, we provide schistosomiasis health education to students once a month through community health volunteers for a duration of six months.
After that, the community health volunteers no longer visit the school for health education until the completion of a one-year follow-up period.
Other Names:
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No Intervention: Control A
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
The control arm received conventional education.
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No Intervention: Control B
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
The control arm received conventional education.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attitudes Changes
Time Frame: before the intervention, six months after the intervention, and at the end of the one-year observation period
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Measurement Tool: "Schistosomiasis Attitudes Questionnaire" Description: This questionnaire assesses the attitudes level of students regarding schistosomiasis. Scale Title: Schistosomiasis Attitudes Questionnaire Range: Minimum value: 11, Maximum value: 55 Interpretation: Higher scores indicate more positive attitudes related to schistosomiasis |
before the intervention, six months after the intervention, and at the end of the one-year observation period
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Behaviors Changes
Time Frame: before the intervention, six months after the intervention, and at the end of the one-year observation period
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Measurement Tool: "Schistosomiasis Behaviors Questionnaire" Description: This questionnaire assesses the behaviors level of students regarding schistosomiasis. Scale Title: Schistosomiasis Behaviors Questionnaire Range: Minimum value:10 , Maximum value:30 Interpretation: Higher scores indicate more positive behaviors related to schistosomiasis |
before the intervention, six months after the intervention, and at the end of the one-year observation period
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Change in Infection Rate
Time Frame: before the intervention, six months after the intervention, and at the end of the one-year observation period
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For biological sample collection, students provided first-morning urine samples (30-50 mL) in sterile, pre-labeled wide-mouth containers under teacher supervision to ensure protocol adherence.
Certified laboratory technicians performed standardized filtration and microscopic analysis to detect S. haematobium eggs.
All egg counts were initially recorded manually, then entered into a Microsoft Excel database using dual-entry verification to maintain data integrity.
Infection intensity classified by WHO criteria (light: 1-49 eggs/10ml urine; heavy: ≥ 50 eggs/10ml urine)
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before the intervention, six months after the intervention, and at the end of the one-year observation period
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Change in Knowledge Scores
Time Frame: before the intervention, six months after the intervention, and at the end of the one-year observation period
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Measurement Tool: "Schistosomiasis Knowledge Questionnaire" Description: This questionnaire assesses the knowledge level of students regarding schistosomiasis. Scale Title: Schistosomiasis Knowledge Questionnaire Range: Minimum value: 0, Maximum value: 10 Interpretation: Higher scores indicate a better understanding of schistosomiasis |
before the intervention, six months after the intervention, and at the end of the one-year observation period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Student satisfaction survey
Time Frame: before the intervention, six months after the intervention, and at the end of the one-year observation period.
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Student Satisfaction Scale, ranging from 2 to 6, where higher scores indicate greater satisfaction.
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before the intervention, six months after the intervention, and at the end of the one-year observation period.
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Collaborators and Investigators
Investigators
- Study Chair: Saleh Juma, MSc, NTD office in Pemba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PembaMoH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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