Re-infection Rates of Soil-transmitted Helminth Infections Among School-aged Children Following a Single or a 4-monthly Health Hygiene Education: an Open Label Clinical Trial
Phase: NA
Conditions: Helminthiasis, Ascaris Infection, Trichuris Infection, Hookworm Infections, Children, Only
Sponsor: Universitas Sumatera Utara

1 March 2019 
 
 
Reinfection rates of soil-transmitted 
helminth infections among school 
aged-children following a single or a 4-
monthly health hygiene education: an 
open label clinical trial 
 
 
 
 
 
 
Study Protocol 
 
 
 
Inke Nadia D. Lubis, MD, PhD 
Rizky Keumala Ansari Nasution, MD 
Badai Buana Nasution, MD 
Hendri Wijaya, MD 
Aridamuriany D. Lubis, MD 
Munar Lubis, MD 
 
Universitas Sumatera Utara 
Medan, Indonesia 
2019 
 

1 March 2019 
BACKGROUND 
 
Soil-transmitted helminth (STH) infections (Ascaris lumbricoides, Trichuris 
trichiura, and hookworm) are important neglected tropical diseases.1 It is 
widely spread in tropical and subtropical regions with an estimation of 1.5 
millions individuals affected in 2018. This infection occurs in 267 millions pre-
school children and 568 millions of school-aged children.2 In Indonesia, the 
prevalence of STH ranges from 45 to 65%, and in poor sanitation areas the 
prevalence increases to 80%.3,4 
 
Several factors have been associated with the high prevalence of 
helminthiasis including poor personal hygiene such as handwashing habit, 
access to good sanitation, and water availability.5 Ideal disease prevention 
and control measures should include those aforementioned, nevertheless 
without good education those interventions may cause recurrent infections.6 
 
The primary aim of this study is to evaluate the effectiveness of video 
health hygiene education on STH reinfection rates among school-aged 
children. The secondary objectives of this study include: 
 
1. To determine the prevalence of STH infections among school-aged 
children prior to intervention 
2. To evaluate the knowledge of STH prevention measures among school-
aged children before and after intervention 
 
 

1 March 2019 
METHODS 
 
Study Design 
This is an open label clinical trial comparing the effectiveness of single and 
repeated video health hygiene education among school-aged children. 
 
Plate and Time 
The study is done in Singkuang Elementary School and Sikapas Elementary 
School in Mandailing Natal district, North Sumatera province, Indonesia from 
March 2019 to March 2020. 
 
 
Gambar 1. Mandailing Natal district of North Sumatera province, 
Indonesia 
 
  
 

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Subjects 
Subjects are children who have negative results on Kato Katz examination 
after receiving 400 mg of albendazole for 3 days. 
 
Sample size 
The sample size of this study was calculated using the following formula:  
             𝑛1 = 𝑛2 =
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!
 
dimana: 
n1 : sample size for study arm with intervention 
n2 : sample size for study arm without intervention 
Zα : 95% significant value = 1,96 
Zβ : 80% power = 0.842 
P1 : Significant differences, 0,62 
P2 : STH prevalence 0.75 
Q1 : 1-P1 = 0.38 
Q2 : 1-P2 = 0.25 
P : ½ (P1+P2) = 0.69 
Q : 1-P = 0.31 
According to above formula, the minimum sample size for each arm with 10% 
add is 216 children. 
 
Inclusion criteria 
1. Student with negative result on Kato Katz examination after receiving 
400 mg of albendazole for 3 days 
 

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Exclusion criteria 
1. Parents who did not give consent 
2. Severe malnutrition 
3. Co-infected with other helminth infections 
 
Ethics 
Parents or guardians will receive a participant information sheet and an 
informed consent form in Bahasa Indonesia. This study has been approved by 
the Health Ethical Research Committee of Faculty of Medicine, Universitas 
Sumatera Utara (#177/TGL/KEPK FK USU-RSUP HAM/2019). 
 
Study Protocol 
1. Consent will be sought from the parents or guardiong of children with 
negative results on Kato Katz examination after receiving 400 mg of 
albendazole for 3 days.  
2. Each student will be asked to fill in a questionnaire comprises of 
knowledge on helminthiasis, attitude and practice on STH prevention. 
3. Observation on the cleanliness of both hands’ nails will be done. 
4. Education on health hygiene and helminthiasis prevention will be given in 
a form of video. 
5. Two schools will be selected to receive either single or repeated education 
every 4 months 
6. At month 4, stool examination using Kato Katz examination will be 
performed and similar questionnaire will be given and observation on the 
nails of the students will be done again. 

1 March 2019 
7. Treatment using albendazole will be given to children infected with STH on 
Kato Katz examination 
8. Re-education will be given to study arm A (school 1) and no intervention 
will be given to study arm B (school 2) 
9. At month 8, stool examination using Kato Katz examination will be 
performed and similar questionnaire will be given and observation on the 
nails of the students will be done again. 
10. Treatment using albendazole will be given to children infected with STH on 
Kato Katz examination 
11. Re-education will be given to study arm A (school 1) and no intervention 
will be given to study arm B (school 2) 
12. At month 12, stool examination using Kato Katz examination will be 
performed and similar questionnaire will be given and observation on the 
nails of the students will be done again. 
13. Treatment using albendazole will be given to children infected with STH on 
Kato Katz examination 
14. Re-education will be given to study arm A (school 1) and no intervention 
will be given to study arm B (school 2) 
15. All results will be recorded, statistical analysis will be performed to 
determine association between single or repeated education and re-
infection occurrence 
 
 
 
 

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Study Procedures 
a. Kato Katz examination 
a) Use gloves to prevent infection 
b) Label a glass slide according to the stool pot ID 
c) Place a small amount of faecal sample on an absorable paper and press 
a wire net on top 
d) Using spatula, scrape the sieve faecal material through the screen so 
that only the debris remains 
e) Scrape up some of the sieved faeces to fill the hole in the template, 
avoiding air bubbles and leveling the faeces off to remove any excess. 
The estimate weight of the faecal is 41.7 mg 
f) Carefully lift off the template and place it on the glass slide 
g) Place one piece of the cellophane, which has been soaked overnight in 
methylene blue glycerol solution, over the faecal sample 
h) Place a clean slide over the top and press it downwards to spread the 
faeces in circle. Carefully remove the slide by gently sliding it sideways 
to avoid separating the cellophane trip.  
i) Place the slide under a microscope and examine the whole area in a 
systematic zigzag pattern 
j) Record the number and the type of each egg of each species on a 
recording form alongside the sample number 
k) Multiply the number of eggs by the appropriate number to give the 
number of eggs per gram (epg) – the standard measurement to assess 
the intensity of infection 
 

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Intensity of ascariasis = Numbers of positive eggs x 1000/R  
Intensity of trichuriasis = Numbers of positive eggs x 1000/R                                 
Intensity of hookworm = Numbers of positive eggs x 1000/R                                 
 
*R = faecal weigh according to the template (mg) 
 
Intervention 
Education will be given in a form of video with a length of 12 minutes, the 
education comprises of health promotion in helminthiasis including etiology, 
risk factors, clinical symptoms, treatment and prevention. 
Education will be given to all children on month 0, and repeat education will 
only be given to study arm 1 at month 4 and 8. 
 
Treatment 
Children with positive results on Kato Katz examination will receive treatment 
according to the findings. Single infection with A. lumbricoides or hookworm 
will be treated with 400 mg of albendazole single dose. Single infection with T. 
trichiura will be treated with 3 days of daily dose 400 mg of albendazole. 
In case of mixed infection, coinfection of A. lumbricoides and 
hookworm will be treated with single dose 400 mg of albendazole. While 
mixed infection of A. lumbricoides or hookworm with T. trichiura will be treated 
with 3 days of daily dose 400 mg of albendazole. 
 
Analysis 

1 March 2019 
Primary outcome of this study is the proportion of children with STH infection 
at month 12 in each group. Secondary outcomes include baseline prevalence 
of STH infection; knowledge of children prior intervention and at months 4, 8 
and 12. 
 
Data will be analysed using SPSS v22, 2010, using confidence interval 
of 95% and significant value is set at 0.05. 
 
Monitoring  
This study will be registerd to clinicaltrials.gov and complies with international 
guidelines for clinical trial reporting. Experienced staf including senior 
physician will be recruited to perform the study, to monitor participants closely 
and to ensure that the rights, safety and the wellbeing of the human subjects 
in the study are in accordance with the study protocol, ICH and GCP 
guidelines. 
 
Reporting 
At the end of the study, the investigator will prepare a report to be reviewed by 
advisors and later to be shared with the Provincial Health Office of North 
Sumatera. The results of the study will also be presented in several 
conferences and will be published in a scientific journal. 
 
 
 
 
 

1 March 2019 
 
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https://www.who.int/intestinal_worms/disease/en/ 
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