Trial Outcomes & Findings for Health Education Model Led by Community Health Volunteers. (NCT NCT06312462)
NCT ID: NCT06312462
Last Updated: 2025-10-10
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
978 participants
Primary outcome timeframe
before the intervention, six months after the intervention, and at the end of the one-year observation period
Results posted on
2025-10-10
Participant Flow
Participant milestones
| Measure |
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.
|
Control A
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers, but receive conventional health education.
|
Control B
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers, but receive conventional health education.
|
|---|---|---|---|
|
Overall Study
STARTED
|
278
|
324
|
376
|
|
Overall Study
COMPLETED
|
245
|
295
|
346
|
|
Overall Study
NOT COMPLETED
|
33
|
29
|
30
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Health Education Model Led by Community Health Volunteers.
Baseline characteristics by cohort
| Measure |
CHVs Intervention Group
n=245 Participants
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.
|
Control A
n=295 Participants
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers, but receive conventional health education intervention.
|
Control B
n=346 Participants
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers, but receive conventional health education intervention.
|
Total
n=886 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.75 years
STANDARD_DEVIATION 1.441 • n=5 Participants
|
11.98 years
STANDARD_DEVIATION 1.370 • n=7 Participants
|
11.97 years
STANDARD_DEVIATION 1.368 • n=5 Participants
|
11.87 years
STANDARD_DEVIATION 1.405 • n=4 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
535 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
351 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
245 Participants
n=5 Participants
|
295 Participants
n=7 Participants
|
346 Participants
n=5 Participants
|
886 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: before the intervention, six months after the intervention, and at the end of the one-year observation periodFor 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)
Outcome measures
| Measure |
CHVs Intervention Group
n=245 Participants
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.
|
Control A
n=295 Participants
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
|
Control B
n=346 Participants
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
|
|---|---|---|---|
|
Change in Infection Rate
baseline(T1)
|
47 Number of Participants with S. haematobi
|
35 Number of Participants with S. haematobi
|
3 Number of Participants with S. haematobi
|
|
Change in Infection Rate
six months after the intervention（T2）
|
6 Number of Participants with S. haematobi
|
4 Number of Participants with S. haematobi
|
3 Number of Participants with S. haematobi
|
|
Change in Infection Rate
at the end of the one-year observation period（T3）
|
2 Number of Participants with S. haematobi
|
3 Number of Participants with S. haematobi
|
5 Number of Participants with S. haematobi
|
PRIMARY outcome
Timeframe: before the intervention, six months after the intervention, and at the end of the one-year observation periodMeasurement 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
Outcome measures
| Measure |
CHVs Intervention Group
n=245 Participants
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.
|
Control A
n=295 Participants
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
|
Control B
n=346 Participants
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
|
|---|---|---|---|
|
Change in Knowledge Scores
before the intervention（T1）
|
6.11 Scores
Standard Deviation 1.79
|
6.42 Scores
Standard Deviation 1.56
|
6.27 Scores
Standard Deviation 1.47
|
|
Change in Knowledge Scores
six months after the intervention（T2）
|
7.13 Scores
Standard Deviation 1.44
|
6.62 Scores
Standard Deviation 1.32
|
7.22 Scores
Standard Deviation 1.23
|
|
Change in Knowledge Scores
at the end of the one-year observation period（T3）
|
7.11 Scores
Standard Deviation 1.35
|
6.56 Scores
Standard Deviation 1.70
|
6.62 Scores
Standard Deviation 1.56
|
PRIMARY outcome
Timeframe: before the intervention, six months after the intervention, and at the end of the one-year observation periodMeasurement 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
Outcome measures
| Measure |
CHVs Intervention Group
n=245 Participants
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.
|
Control A
n=295 Participants
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
|
Control B
n=346 Participants
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
|
|---|---|---|---|
|
Attitudes Changes
before the intervention（T1）
|
38.02 Scores
Standard Deviation 8.49
|
39.06 Scores
Standard Deviation 8.96
|
39.37 Scores
Standard Deviation 9.98
|
|
Attitudes Changes
six months after the intervention（T2）
|
41.2 Scores
Standard Deviation 8.66
|
41.24 Scores
Standard Deviation 8.15
|
42.55 Scores
Standard Deviation 8.85
|
|
Attitudes Changes
at the end of the one-year observation period（T3）
|
43.58 Scores
Standard Deviation 8.95
|
41.39 Scores
Standard Deviation 8.58
|
41.44 Scores
Standard Deviation 10.68
|
PRIMARY outcome
Timeframe: before the intervention, six months after the intervention, and at the end of the one-year observation periodMeasurement 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
Outcome measures
| Measure |
CHVs Intervention Group
n=245 Participants
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.
|
Control A
n=295 Participants
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
|
Control B
n=346 Participants
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
|
|---|---|---|---|
|
Behaviors Changes
before the intervention（T1）
|
19.05 Scores
Standard Deviation 2.74
|
19.35 Scores
Standard Deviation 2.87
|
19.43 Scores
Standard Deviation 2.62
|
|
Behaviors Changes
six months after the intervention（T2）
|
20.56 Scores
Standard Deviation 2.84
|
20.25 Scores
Standard Deviation 2.64
|
19.77 Scores
Standard Deviation 2.59
|
|
Behaviors Changes
at the end of the one-year observation period（T3）
|
20.7 Scores
Standard Deviation 2.912
|
20.14 Scores
Standard Deviation 2.66
|
19.6 Scores
Standard Deviation 2.6
|
Adverse Events
CHVs Intervention Group
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Control A
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Control B
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CHVs Intervention Group
n=278 participants at risk
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.
|
Control A
n=324 participants at risk
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
|
Control B
n=376 participants at risk
A group of students who do not receive schistosomiasis health education intervention led by community health volunteers.
|
|---|---|---|---|
|
Investigations
school transfers
|
1.1%
3/278 • Number of events 33 • 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.
|
0.62%
2/324 • Number of events 29 • 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.
|
1.1%
4/376 • Number of events 30 • 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.
|
|
Investigations
absenteeism
|
1.8%
5/278 • Number of events 33 • 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.
|
1.2%
4/324 • Number of events 29 • 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.
|
1.6%
6/376 • Number of events 30 • 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.
|
|
Investigations
incomplete samples
|
9.0%
25/278 • Number of events 33 • 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.
|
7.1%
23/324 • Number of events 29 • 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.
|
5.3%
20/376 • Number of events 30 • 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.
|
Additional Information
Dr. Huang Yuzheng
Jiangsu Institute of Parasitic Diseases
Phone: 19941716698
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place