ClinicalTrials.gg
CompletedNCT06312462Updated Oct 8, 2026Results posted

Health Education Model Led by Community Health Volunteers.

An interventional study of health education in Schistosomiasis and Health Education, sponsored by Pemba Ministry of Health Zanzibar. Completed at 1 site in Tanzania. Open to participants aged 7 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Pemba Ministry of Health Zanzibar · Not applicable, Interventional, and Health services research

Updated Oct 8, 2026Posted results revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
978
Allocation
Randomized
Ages
7 Years to 15 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Schistosomiasis
  • Health Education

Keywords

  • Schistosomiasis
  • CHVs
  • KAP
03

In context

Schistosomiasis

79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.

This study's enrollment of 978 is above the median of 289 across 52 interventional studies indexed under Schistosomiasis.

Browse Schistosomiasis studies →

Lead sponsor

Pemba Ministry of Health Zanzibar is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and participate in the study Students residing in schistosomiasis-endemic areas

Exclusion criteria

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 or participate in the study Students who have been diagnosed with other serious illnesses.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
978 participants (actual)

Study arms

  • Experimental
    CHVs Intervention group

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

    Behavioral: health education

  • 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.

  • 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.

Interventions

  • Behavioralhealth 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.

    Also known as: led by community health volunteers

06

What researchers measure

Primary outcomes

  1. 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)

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

  2. 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

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

  3. 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

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

  4. 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

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

07

Results

Posted Oct 10, 2025

Participant flow

Participant flow — Overall Study
MilestoneCHVs Intervention GroupControl AControl B
Started278324376
Completed245295346
Not completed332930

Outcome measures

PrimaryChange 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)

Time frame:
before the intervention, six months after the intervention, and at the end of the one-year observation period
Reported as:
Number · Number of Participants with S. haematobi
Change in Infection Rate
Number of Participants with S. haematobiCHVs Intervention GroupControl AControl B
baseline(T1)47353
six months after the intervention(T2)643
at the end of the one-year observation period(T3)235
PrimaryChange 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

Time frame:
before the intervention, six months after the intervention, and at the end of the one-year observation period
Reported as:
Mean · Scores
Change in Knowledge Scores
ScoresCHVs Intervention GroupControl AControl B
baseline(T1)6.11 ± 1.796.42 ± 1.566.27 ± 1.47
six months after the intervention(T2)7.13 ± 1.446.62 ± 1.327.22 ± 1.23
at the end of the one-year observation period(T3)7.11 ± 1.356.56 ± 1.706.62 ± 1.56
PrimaryAttitudes 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

Time frame:
before the intervention, six months after the intervention, and at the end of the one-year observation period
Reported as:
Mean · Scores
Attitudes Changes
ScoresCHVs Intervention GroupControl AControl B
baseline(T1)38.02 ± 8.4939.06 ± 8.9639.37 ± 9.98
six months after the intervention(T2)41.2 ± 8.6641.24 ± 8.1542.55 ± 8.85
at the end of the one-year observation period(T3)43.58 ± 8.9541.39 ± 8.5841.44 ± 10.68
PrimaryBehaviors 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

Time frame:
before the intervention, six months after the intervention, and at the end of the one-year observation period
Reported as:
Mean · Scores
Behaviors Changes
ScoresCHVs Intervention GroupControl AControl B
baseline(T1)19.05 ± 2.7419.35 ± 2.8719.43 ± 2.62
six months after the intervention(T2)20.56 ± 2.8420.25 ± 2.6419.77 ± 2.59
at the end of the one-year observation period(T3)20.7 ± 2.91220.14 ± 2.6619.6 ± 2.6

Adverse events

Collected over 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. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CHVs Intervention Group0/278 (0%)0/278 (0%)33/278 (11.9%)
Control A0/324 (0%)0/324 (0%)29/324 (9%)
Control B0/376 (0%)0/376 (0%)30/376 (8%)
Most frequent other events
Most frequent other events
EventCHVs Intervention GroupControl AControl B
incomplete samplesInvestigations25/27823/32420/376
absenteeismInvestigations5/2784/3246/376
school transfersInvestigations3/2782/3244/376

Baseline characteristics

Age, Continuous
Age, Continuous(years)CHVs Intervention GroupControl AControl BTotal
Mean11.75 ± 1.44111.98 ± 1.37011.97 ± 1.36811.87 ± 1.405
Sex: Female, Male
Sex: Female, Male(Participants)CHVs Intervention GroupControl AControl BTotal
Female145182208535
Male100113138351
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CHVs Intervention GroupControl AControl BTotal
Hispanic or Latino0000
Not Hispanic or Latino0000
Unknown or Not Reported245295346886
08

Study locations

1 site
  • Neglected tropical diseases in Pemba
    Pemba, CharkChark P.O.BOX 98, Tanzania
09

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2024 to primary completion in Feb 2025, 12 months.

Results were first posted in Oct 2025, 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2024
First posted
Mar 15, 2024
StartActual
Feb 24, 2024
Primary completionActual
Feb 28, 2025
CompletionActual
Mar 8, 2025
Results first posted
Oct 10, 2025
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Results
Posted results revised
revised Oct 8, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 42816868 ↗
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Posted results revised
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 42816868 ↗
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT06312462
Lead sponsor
Pemba Ministry of Health Zanzibar
Responsible party
Sponsor
First posted
Mar 15, 2024
Start date
Feb 24, 2024
Primary completion
Feb 28, 2025
Completion
Mar 8, 2025
Results posted
Oct 10, 2025
Last update
Oct 8, 2026

Study contacts

Saleh Juma, MSc
study chair · NTD office in Pemba

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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