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The goal of this intervention study is to investigate the level of knowledge, attitudes, and behaviors of students on schistosomiasis in Pemba Island. It aims to test the effectiveness of establishing a widely applicable Community Health Volunteers model in the Zanzibar region and explore the feasibility of promoting this model in other areas of Africa. This study also aims to provide valuable insights and references for global schistosomiasis prevention and control efforts.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHVs Intervention group | Experimental | A group of students who receive schistosomiasis health education intervention led by community health volunteers. |
|
| Control A | No Intervention | A group of students who do not receive schistosomiasis health education intervention led by community health volunteers. The control arm received conventional education. | |
| Control B | No Intervention | A group of students who do not receive schistosomiasis health education intervention led by community health volunteers. The control arm received conventional education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| health education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Infection Rate | 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) | before the intervention, six months after the intervention, and at the end of the one-year observation period |
| Change in Knowledge Scores | 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 |
| Attitudes Changes | 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 |
| Behaviors Changes | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saleh Juma, MSc | NTD office in Pemba | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neglected tropical diseases in Pemba | Pemba | CharkChark | P.O.BOX 98 | Tanzania |
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| ID | Title | Description |
|---|---|---|
| FG000 | CHVs Intervention Group | A group of students who receive schistosomiasis health education intervention led by community health volunteers. health education: 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. |
| FG001 | Control A | A group of students who do not receive schistosomiasis health education intervention led by community health volunteers, but receive conventional health education. |
| FG002 | Control B | A group of students who do not receive schistosomiasis health education intervention led by community health volunteers, but receive conventional health education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CHVs Intervention Group | A group of students who receive schistosomiasis health education intervention led by community health volunteers. health education: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Infection Rate | 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) | Posted | Number | Number of Participants with S. haematobi | before the intervention, six months after the intervention, and at the end of the one-year observation period |
|
During the two subsequent follow-up waves : six months after the intervention(2024.08.30): strict individual self-matching and accounting for attrition (school transfers, absenteeism, and incomplete samples; at the end of the one-year observation period(2025.02.27): strict individual self-matching and accounting for attrition (school transfers, absenteeism, and incomplete samples
This research does not involve drug studies and will not endanger the lives of the participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CHVs Intervention Group | A group of students who receive schistosomiasis health education intervention led by community health volunteers. health education: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| school transfers | Investigations | Non-systematic Assessment | This research does not involve drug studies and will not endanger the lives of the participants. Adverse events were present due to the following circumstances: school transfers, absenteeism, and incomplete samples. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Huang Yuzheng | Jiangsu Institute of Parasitic Diseases | 19941716698 | huangyuzheng@jipd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2025 | Sep 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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This model evaluates the effectiveness of schistosomiasis health education led by community health volunteers by training the volunteers on Pemba Island and having them conduct health education for local students. It also discusses the feasibility of promoting this model in Africa.
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| before the intervention, six months after the intervention, and at the end of the one-year observation period |
| BG001 | Control A | A group of students who do not receive schistosomiasis health education intervention led by community health volunteers, but receive conventional health education intervention. |
| BG002 | Control B | A group of students who do not receive schistosomiasis health education intervention led by community health volunteers, but receive conventional health education intervention. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Control A | A group of students who do not receive schistosomiasis health education intervention led by community health volunteers. |
| OG002 | Control B | A group of students who do not receive schistosomiasis health education intervention led by community health volunteers. |
|
|
| Primary | Change in Knowledge Scores | 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 | Posted | Mean | Standard Deviation | Scores | before the intervention, six months after the intervention, and at the end of the one-year observation period |
|
|
|
| Primary | Attitudes Changes | 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 | Posted | Mean | Standard Deviation | Scores | before the intervention, six months after the intervention, and at the end of the one-year observation period |
|
|
|
| Primary | Behaviors Changes | 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 | Posted | Mean | Standard Deviation | Scores | before the intervention, six months after the intervention, and at the end of the one-year observation period |
|
|
|
| 0 |
| 278 |
| 0 |
| 278 |
| 33 |
| 278 |
| EG001 | Control A | A group of students who do not receive schistosomiasis health education intervention led by community health volunteers. | 0 | 324 | 0 | 324 | 29 | 324 |
| EG002 | Control B | A group of students who do not receive schistosomiasis health education intervention led by community health volunteers. | 0 | 376 | 0 | 376 | 30 | 376 |
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| absenteeism | Investigations | Non-systematic Assessment |
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| incomplete samples | Investigations | Non-systematic Assessment |
|
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| D000079426 |
| Vector Borne Diseases |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| at the end of the one-year observation period（T3） |
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| at the end of the one-year observation period（T3） |
|
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| at the end of the one-year observation period（T3） |
|