A school-based health education package for prevention of soil-transmitted helminth infections in the Philippines

• Register: ANZCTR
• Last refreshed on: 26 July 2021
• Main ID: ACTRN12616000508471
• Date of registration: 20/04/2016
• Prospective Registration: Yes
• Primary sponsor: Darren Gray
• Public title: A school-based health education package for prevention of soil-transmitted helminth infections in the Philippines
• Scientific title: Filipino schoolchildren cartoon-based health education package versus a control for the prevention of soil-transmitted helminth infections
• Date of first enrolment: 11/06/2016
• Target sample size: 1760
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000508471.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Philippines

Contacts

• Name: A/Prof Darren Gray

• Name: A/Prof Darren Gray

Key inclusion & exclusion criteria

Inclusion criteria: Grade 4 pupil of study school
Pupil at school for duration of study
Informed consent obtained
Age 9-11 years
Exclusion criteria: No informed consent
Outside of specified age range
Pupil will not be present for duration of study

Age minimum: 9 Years
Age maximum: 11 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Studies of infection and infectious agents

Public Health - Epidemiology

Public Health - Health promotion/education

Soil-transmitted helminths: Trichuris, Ascaris, Hookworm;
Soil-transmitted helminths: Trichuris, Ascaris, Hookworm

Intervention(s)

The intervention will be a video-based health education package comprised of: 1) health education cartoon: narrative 12 min cartoon video; content: story about a boy who gets infected with Soil-transmitted Helminths (STH) because of unhygienic behaviour. Key messages: a) symptoms of the disease. b) where and how can children get infected. c) how can disease be prevented. 2) A take-home pamphlet with key messages; 3) Classroom discussions; and 4) Drawing and essay competitions for key message reinforcement.

The cartoon will be shown twice (immediately following each other) in June/July 2016 followed by distribution of the pamphlet and classroom discussions (for 10-15 mins post the viewing by the research team assisted by the child's regular teacher); and then shown twice (immediately following each other) in August/September 2016 followed by classroom discussions (for 10-15 mins post the viewing by the research team assisted by the child's regular teacher) and the drawing and essay competitions. This will take place in the intervention schools.

Albendazole chemotherapy will be administered following the baseline survey in July 2016 in all study schools. Albendazole will also be administered to those found positive at the two follow-up surveys in Feb 2017 and Feb 2018 respectively. The Albendazole regimen will follow standard World Health Organization (WHO) guidelines (a single oral dose of 400mg). This will done in concert with the National de-worming program in the Philippines

Intervetnion and drug delivery will be directly observed and record kept for monitoring purposes

Primary Outcome(s)

Soil-transmitted helminth infection rate will be assessed by follow-up
parasitological stool tests using Kato-Katz thick smear to count the
parasite eggs per species. Molecular diagnostics will also be undertaken.[Soil-transmitted helminth infection rates will be assessed at baseline (June/July 2016) and then at each follow-up (Feb/March 2017 and Feb/March 2018).]

Child's knowledge on infection risk of soil-transmitted helminth will be assessed with baseline and follow-up questionnaires. These questionnaires were designed specifically for the study, although they were an adaptation (to the Filippino context) of what we have used in previous trials in China[Knowledge will be assessed at baseline (July/August 2015) and at follow-up (Feb/March 2016 and Feb/March 2017).]

Secondary Outcome(s)

Measures of STH associated morbidity (academic performance). This will be measured by school attendance and academic grades (obtained from school records); at baseline and follow-up.
[Assessed at baseline (June/July 2016) and at follow-up (Feb/March 2017 and Feb/March 2018).]

Measures of STH associated morbidity (stunted growth). This will be measured by height and weight (stadiometer and calibrated digital scales) at baseline and follow-up.
[Assessed at baseline (June/July 2016) and at follow-up (Feb/March 2017 and Feb/March 2018).]

Measures of STH associated morbidity (anaemia). This will be measured by Haemoglobin levels (blood via finger prick and Hb machine) at baseline and follow-up.[Morbidity measures will be assessed at baseline (June/July 2016) and at follow-up (Feb/March 2017 and Feb/March 2018).]

Secondary ID(s)

Nil

Source(s) of Monetary Support

National Health and Medical Research Council

United Bank of Switzerland (UBS) Optimus Foundation

Secondary Sponsor(s)

Donald McManus

Ethics review

Status: Approved
Approval date: 16/04/2013
Contact:

QIMR Berghofer Medical Research Institute Human Ethics Committee

Status: Approved
Approval date: 13/05/2013
Contact:

University of Queensland Medical Research Ethics Committee

Status: Approved
Approval date: 30/10/2014
Contact:

Australian National University Human Ethics Committee