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A randomized controlled trial to evaluate the impact of combining hygiene education with deworming.

A randomized controlled trial to evaluate if combining school-based hygiene education with mass drug administration (MDA) of deworming medication decreases the reinfection rate of soil-transmitted helminths (STH) in school-age children.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001048370
Enrollment
9827
Registered
2017-07-18
Start date
2017-10-02
Completion date
2017-10-30
Last updated
2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

School-based MDA campaigns, whereby anti-helminthic medication is administered to school-age children, are a model proven to cost-effectively control intestinal worm infections. However, deworming MDAs do not prevent reinfection and need to be repeated regularly, with frequency of treatment dependent upon prevalence levels. The Government of Vietnam has determined to provide annual treatment in the intervention area, and in order to determine how to reduce reinfection rates of STH, the research partners are interested in evaluating the integration of a school-based health education package with the deworming MDA. There is a general assumption that greater knowledge of health and sanitation issues amongst children will lead to greater and longer-term reductions in reinfection compared to deworming alone, but there is a lack of rigorous studies to confirm this. In order to address the lack of evidence, we will conduct a cluster randomized controlled trial (RCT) to evaluate the impact of such an integrated approach. A consortium from the Australian National University, QIMR Berghofer Medical Research Institute and University of Queensland has previously demonstrated that students exposed to a hygiene education package featuring an educational video (“Magic Glasses”) in line with receiving deworming medication, supplemented with class-based supporting activities throughout the school year, suffered roughly half the worm infections of those receiving deworming medication alone (Bieri F.A., et al (2013) Health education package to prevent worm infections in Chinese schoolchildren. NEJM (368): 1603-1612). Due to the striking effects of this intervention on reinfection rates, combined with the potential for scale, we are interested to rigorously evaluate if a similar impact with a scaled-down version of this intervention can be achieved in Vietnam. The purpose of the experiment is to conduct an effectiveness study of the integrated intervention, not an efficacy study; the experiment will evaluate whether the integrated intervention can be implemented at scale in the particular context under consideration, not under rigid experimental conditions. It is anticipated that this large-scale RCT will provide evidence about whether the hygiene education package is successful and cost-effective at reducing reinfection among school-age children when combined with school-based deworming. The results of this research will be used to inform the design of a nationwide deworming program in Vietnam.

Interventions

The core goal of the study is to assess if adding a hygiene education package, designed to be implemented at scale, to deworming campaigns can improve the success of deworming by reducing the reinfection rate in children. Accordingly, there are two components to the intervention: (i) a hygiene education package; and (ii) distribution of deworming tablets via mass drug administration of deworming medication at schools. Brief name of Intervention: Integrated hygiene education and deworming MDA.

The core goal of the study is to assess if adding a hygiene education package, designed to be implemented at scale, to deworming campaigns can improve the success of deworming by reducing the reinfection rate in children. Accordingly, there are two components to the intervention: (i) a hygiene education package; and (ii) distribution of deworming tablets via mass drug administration of deworming medication at schools. Brief name of Intervention: Integrated hygiene education and deworming MDA. A single hygiene education package comprising two components will be evaluated in combination with deworming MDAs: 1) A short cartoon (‘Magic Glasses’) originally evaluated by Bieri and colleagues [Bieri F.A., et al (2013) Health education package to prevent worm infections in Chinese schoolchildren. NEJM (368): 1603-1612]. This cartoon, approximately 14 minutes in duration, explains to children: (a) how STH infections are transmitted (e.g. poor sanitation practices such as defecating in fields rather than using latrines; poor hygiene practices such as not washing hands after defecating or not washing food before eating); (b) the health consequences of STH infections (e.g. abdominal pain, diarrhoea, fatigue, lack of concentration at school); and (c) how children can minimize their risk of being infected by STH by improving their hygiene and sanitation habits. 2) A pamphlet, based on the Magic Glasses cartoon. This pamphlet shows screenshots from the cartoon, aiming to reinforce the key messages from the cartoon about how children can change their hygiene and sanitation habits to minimize their risk of STH infection. The intervention will comprise teachers showing the Magic Glasses cartoon to their students twice during the academic year. The first delivery of the hygiene education package will be the week prior to a government-implemented deworming MDA; the second delivery of the intervention will be approximately 6 months later: 1) During the first delivery of the intervention, teachers will show the Magic Glasses cartoon to their students twice during a single class period, in combination with teachers distributing pamphlets to the children to take home. This first delivery will take place as part of a broader deworming program -- government-implemented school-based deworming MDAs will take place annually in the province of Phu Tho, targeting all primary schools (children aged 6-11 years old). School-based deworming MDAs in Phu Tho (and throughout Vietnam) are conducted by local health workers visiting schools and distributing a single tablet (either albendazole [400 milligrams] or mebendazole [500 milligrams]) to each child present on the day. A mop-up day is conducted three to four days later to deworm children who were not able to receive a tablet on the first day due to absence, illness, etc. The intervention to be tested in this study will leverage the government-implemented, province-wide, school-based deworming MDA in Phu Tho which will take place in November, 2017. 2) The second delivery of the intervention will also entail teachers showing the Magic Glasses cartoon (twice) in a single class period; however, for the second delivery, there will be no pamphlets distributed, nor deworming MDA conducted. Depending on school infrastructure, the Magic Glasses cartoon could be shown either on a one classroom/grade at a time basis or some other combination of classrooms – schools will be free to devise their own mechanism of how to deliver the intervention, with the only stipulation that they ensure the cartoon is displayed on a clearly visible screen (some schools will utilize computers and projectors, while others will utilize a television (TV) and video compact disc (VCD) player; the cartoon will be provided to schools on a VCD). Adherence of the schools to showing the video will be assessed through a simple form filled-in by teachers. This form will report if the video was or was not shown at each of the two expected delivery times. Fidelity to a specific teaching regime will not be assessed: this is an effectiveness study designed to evaluate whether the integrated intervention can be implemented at scale in the particular context under consideration, not under rigid experimental conditions. The integrated intervention will target all primary school classes (grade 1-5; age 6-11 years old).

Sponsors

Ms. Duong Hong Loan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention

Eligibility

Sex/Gender
All
Age
6 Years to 11 Years
Healthy volunteers
Yes

Inclusion criteria

The target population of this intervention is primary school children (grade 1 to 5; age 6-11 years old) receiving deworming treatment as part of an annual province-wide school-based deworming MDA in Phu Tho. All children from participating schools will receive the intervention designated to their cohort, but the study will be based on studying children from grade 4 (age 9-10 years old). At each participating school, all children from grade 4 will be recruited to a longitudinal cohort.

Exclusion criteria

All children from participating schools will receive the intervention designated to their cohort, but the study will be based on studying children from grade 4 (age 9-10 years old). Children younger than this will be excluded as they are considered unlikely to provide reliable responses to questionnaires; children older than this be excluded as they will not be available for follow-up in the next school year.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026