NCT06312462

Brief 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 this model in other areas of Africa. This study also aims to provide valuable insights and references for global schistosomiasis prevention and control efforts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
978

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

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

February 24, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2025

Completed
7 months until next milestone

Results Posted

Study results publicly available

October 10, 2025

Completed
Last Updated

October 10, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

February 27, 2024

Results QC Date

July 15, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

SchistosomiasisCHVsKAP

Outcome Measures

Primary Outcomes (4)

  • 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

    before the intervention, six months after the intervention, and at the end of the one-year observation period

Study Arms (3)

CHVs Intervention group

EXPERIMENTAL

A group of students who receive schistosomiasis health education intervention led by community health volunteers.

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.

Interventions

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.

Also known as: led by community health volunteers
CHVs Intervention group

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neglected tropical diseases in Pemba

Pemba, CharkChark, P.O.BOX 98, Tanzania

Location

MeSH Terms

Conditions

SchistosomiasisHealth Education

Condition Hierarchy (Ancestors)

Trematode InfectionsHelminthiasisParasitic DiseasesInfectionsVector Borne DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr. Huang Yuzheng
Organization
Jiangsu Institute of Parasitic Diseases

Study Officials

  • Saleh Juma, MSc

    NTD office in Pemba

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 15, 2024

Study Start

February 24, 2024

Primary Completion

February 28, 2025

Study Completion

March 8, 2025

Last Updated

October 10, 2025

Results First Posted

October 10, 2025

Record last verified: 2025-09

Locations