SchistosomiasisNCT06312462
Health Education Model Led by Community Health Volunteers.
A study testing health education in people with Schistosomiasis and Health Education, run by Pemba Ministry of Health Zanzibar at 1 site in Tanzania.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis, Health Education
- What is being tested?
- health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 978 participants
- Where
- 1 siteTanzania
- Study dates
- 24 Feb 2024to 8 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Neglected tropical diseases in Pemba
Pemba, CharkChark, P.O.BOX 98
About this study
Official title: A Survey on the Knowledge, Attitudes, and Practices of Students Regarding Schistosomiasis Through a Health Education Model Led by Community Health Volunteers.
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.
Read the 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.
- Conditions
- Schistosomiasis, Health Education
- Being tested
- health education
- Keywords
- Schistosomiasis, CHVs, KAP
- Medical subject headings
- Schistosomiasis, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health educationBehavioural
Also called led by community health volunteers
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.
| Study group | Role | What they receive |
|---|---|---|
| CHVs Intervention group | Experimental | A group of students who receive schistosomiasis health education intervention led by community health volunteers. Receives: Behavioral: health education |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: before the intervention, six months after the intervention, and at the end of the one-year observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start24 Feb 2024
- Primary completion28 Feb 2025
- Study completion8 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 978 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pemba Ministry of Health Zanzibar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saleh Juma, MSc, Study chair, NTD office in Pemba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312462
- Sponsor's protocol ID
- PembaMoH
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2024
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li X, Wang Y, He M, Mohammed SJ, Khamis KS, Wang X, Zhou X, Xu Z, Shi L, Suleiman MM, Khamis MA, Dai Y, Sun J, Yang K, Li Y, Huang Y. A community-based participatory research and community health workers-led health education strategy for schistosomiasis control among schoolchildren in Pemba Island, Zanzibar: a cluster-randomized trial. Infect Dis Poverty. 2026 Sep 30;15(1):106. doi: 10.1186/s40249-026-01504-y.
PubMed 42816868
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey on the Knowledge, Attitudes, and Practices of Students Regarding Schistosomiasis Through a Health Education Model Led by Community Health Volunteers.
- ClinicalTrials.gov ID
- NCT06312462
- Acronym / sponsor ID
- PembaMoH
- Conditions
- Schistosomiasis, Health Education
- Keywords
- Schistosomiasis, CHVs, KAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 978 participants (actual)
- Lead sponsor
- Pemba Ministry of Health ZanzibarUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 8 Mar 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Posted 10 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CHVs Intervention group | Experimental | Behavioral: health educationA 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. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health educationAlso: led by community health volunteersIn 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. | Behavioural | CHVs Intervention group |
Primary outcome
Change in Infection Rate
Time frame: before the intervention, six months after the intervention, and at the end of the one-year observation period
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)
Change in Knowledge Scores
Time frame: before the intervention, six months after the intervention, and at the end of the one-year observation period
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
Attitudes Changes
Time frame: before the intervention, six months after the intervention, and at the end of the one-year observation period
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
Behaviors Changes
Time frame: before the intervention, six months after the intervention, and at the end of the one-year observation period
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42816868Li X, Wang Y, He M, Mohammed SJ, Khamis KS, Wang X, Zhou X, Xu Z, Shi L, Suleiman MM, Khamis MA, Dai Y, Sun J, Yang K, Li Y, Huang Y. A community-based participatory research and community health workers-led health education strategy for schistosomiasis control among schoolchildren in Pemba Island, Zanzibar: a cluster-randomized trial. Infect Dis Poverty. 2026 Sep 30;15(1):106. doi: 10.1186/s40249-026-01504-y.
Related trials for Schistosomiasis
Not yet recruitingPhase 3
A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital Schistosomiasis
Female Genital Schistosomiasis
Not yet recruitingPhase 2/3
Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis
Schistosomiasis, Schistosoma Mansoni
Not yet recruiting
Assessment of Right Ventricular-Pulmonary Arterial Coupling in Schistosomiasis-Associated Pulmonary Arterial Hypertension
Schistosomiasis
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
Onchocerciasis (River Blindness), Schistosomiasis
Not yet recruitingObservational study
Nanobody-based Schistosomiasis Urine Test Kit Research
Schistosomiasis Haematobia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saleh Juma, MSc study chair
NTD office in Pemba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health education in people with Schistosomiasis and Health Education, run by Pemba Ministry of Health Zanzibar at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Infection Rate (time frame: before the intervention, six months after the intervention, and at the end of the one-year observation period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06312462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.