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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06312462
Other study ID # PembaMoH
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date May 2025

Study information

Verified date March 2024
Source Pemba Ministry of Health Zanzibar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date May 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 15 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Tanzania Neglected tropical diseases in Pemba Pemba CharkChark

Sponsors (1)

Lead Sponsor Collaborator
Pemba Ministry of Health Zanzibar

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in infection rate By comparing the infection rate data before and after intervention or between the intervention group and the control group, we evaluate the impact of health education on students' health status. before the intervention, six months after the intervention, and at the end of the one-year observation period
Primary Change in Knowledge Level 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
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
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
before the intervention, six months after the intervention, and at the end of the one-year observation period
Secondary Student satisfaction survey Student Satisfaction Scale, ranging from 2 to 6, where higher scores indicate greater satisfaction. before the intervention, six months after the intervention, and at the end of the one-year observation period.
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