(S)WASH-D for Worms: A pilot study investigating the differential impact of school- versus community-based integrated control programs for soil-transmitted helminths

Background Soil-transmitted helminths (STH) infect nearly 1.5 billion individuals globally, and contribute to poor physical and cognitive development in children. STH control programs typically consist of regular delivery of anthelminthic drugs, targeting school-aged children. Expanding STH control programs community-wide may improve STH control among school-aged children, and combining deworming with improvements to water, sanitation and hygiene (WASH) may further reduce transmission. The (S)WASH-D for Worms pilot study aims to compare the differential impact of integrated WASH and deworming programs when implemented at primary schools only versus when additionally implemented community-wide. Methodology/Principal findings A two-arm, non-randomized cluster intervention study was conducted. Six communities were identified by partner WASH agencies and enrolled in the study. All communities received a school-based WASH and deworming program, while three additionally received a community-based WASH and deworming program. STH infections were measured in school-aged children at baseline and six months after deworming. Over 90% of eligible children were recruited for the study, of whom 92.3% provided stool samples at baseline and 88.9% at follow-up. The school WASH intervention improved school sanitation, while the community WASH intervention reduced open defecation from 50.4% (95% CI 41.8–59.0) to 23.5% (95% CI 16.7–32.0). There was a trend towards reduced odds of N. americanus infection among children who received the community-wide intervention (OR 0.42, 95% CI 0.07–2.36, p = 0.32). Conclusions This pilot study provides proof of principle for testing the hypothesis that community-wide STH control programs have a greater impact on STH infections among children than school-based programs, and supports the rationale for conducting a full-scale cluster randomized controlled trial. High recruitment and participation rates and successful implementation of school WASH programs demonstrate study feasibility and acceptability. However, eliminating open defecation remains a challenge; ongoing work is required to develop community sanitation programs that achieve high and sustainable latrine coverage. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12615001012561


Description of intervention(s) / exposure
The intervention to be evaluated in this proposal will involve provision of access to improved water and sanitation and improving related hygiene practices, implemented at both a community level and a primary school level. This intervention will be implemented by non-governmental organisation Plan International in Timor-Leste. The sanitation component will involve construction of school latrines by contractors working with Plan International, as well a Community Led Total Sanitation approach. Access to an improved water supply will also be provided, and local partner NGOs will provide house-by-house education on hygiene practices, in particular hand-washing with soap at critical times. Hygiene education including posters relating to handwashing with soap will be provided to schools, and handwashing stations with soap will be constructed as part of the school latrines.
Furthermore, communities in the intervention arm of the pilot study will receive mass chemotherapy (distributed to all members of the community) with one oral tablet of albendazole 400mg, which will be administered once 80% of the households have sanitation (as de ned by the presence of a household latrine) and the school latrines have been completed. Albendazole intake will be directly observed by the eld workers delivering the tablets, who will be working under the supervision of a registered nurse.

Current page
Review Furthermore, communities in the intervention arm of the pilot study will receive mass chemotherapy (distributed to all members of the community) with one oral tablet of albendazole 400mg, which will be administered once 80% of the households have sanitation (as de ned by the presence of a household latrine) and the school latrines have been completed. Albendazole intake will be directly observed by the eld workers delivering the tablets, who will be working under the supervision of a registered nurse.
The intervention period will continue until the school latrine construction is nished, household latrine construction is complete, hygiene promotion has been conducted in all households and mass chemotherapy has been delivered. This is estimated to take between 2-4 months.

Intervention code [3]
Behaviour Comparator / control treatment Communities in the control group will be provided with access to improved water and sanitation and hygiene promotion implemented only at primary school level. This will be implemented by nongovernmental organisation Cruz Vermelha Timor-Leste (CVTL), and will involve construction of school latrines, access to an improved water supply and promotion of hand washing with soap and related hygiene behaviours. This intervention will be similar to that in the intervention arm (although conducted by a di erent NGO) but will only be delivered to primary school children.
Furthermore, communities in the control arm of the pilot study will receive chemotherapy (distributed to school-aged children only) with one oral tablet of albendazole 400mg, which will be administered once the school latrines have been completed. Albendazole intake will be directly observed by the eld workers delivering the tablets, who will be working under the supervision of a registered nurse.

Outcomes Primary outcome [1]
Cumulative incidence of of infection with A. lumbricoides, T. trichiura, N. americanus and Ancylostoma spp. (undi erentiated) in school aged children -to be assessed by both microscopy and PCR examination of stool

Timepoint [1]
At baseline and at follow-up six months after the distribution of albendazole

Secondary outcome [1]
Proportion of eligible children for whom informed consent is gained -using school records to determine number of eligible children

Timepoint [1]
At baseline and at follow-up six months after the distribution of albendazole

Secondary outcome [2]
Proportion of eligible children for whom stool samples are provided -using school records to determine number of eligible children

Timepoint [2]
At baseline and at follow-up six months after the distribution of albendazole

Secondary outcome [3]
Proportion of eligible children who complete questionnaires -using school records to determine number of eligible children

Timepoint [3]
At baseline and at follow-up six months after the distribution of albendazole

Secondary outcome [4]
Proportion of eligible children who undergo measurement of height, weight and haemoglobin -using school records to determine number of eligible children

Timepoint [4]
At baseline and at follow-up six months after the distribution of albendazole

Timepoint [5]
At baseline and at follow-up six months after the distribution of albendazole

Timepoint [6]
At baseline and at follow-up six months after the distribution of albendazole

Secondary outcome [7]
Anthropometric index weight-for-height Z-score (to identify wasting)

Timepoint [7]
At baseline and at follow-up six months after the distribution of albendazole

Secondary outcome [8]
Anthropometric index weight-for-age Z-score (to identify underweight)

Timepoint [8]
At baseline and at follow-up six months after the distribution of albendazole

Timepoint [9]
At baseline and at follow-up six months after the distribution of albendazole

Secondary outcome [10]
Mean intensity of infection (average number of eggs per gram of faeces)

Timepoint [10]
Six months following distribution of albendazole

Eligibility Key inclusion criteria
Inclusion criteria for enrollment in the study: -Child enrolled in and attending the primary school -Informed consent obtained from parent/caregiver Selection of communities for inclusion in the study: -Communities were selected for inclusion in this pilot study in consultation with each partner NGO (Plan International and Cruz Vermelha Timor-Leste (CVTL)) -For the intervention clusters, Plan International identi ed three villages in which they were planning both a school-and community-based WASH programme.
-For the control clusters, the research team and CVTL identi ed three schools suitable for a schoolbased WASH programme, located in a nearby district to the intervention communities.
International and Cruz Vermelha Timor-Leste (CVTL)) -For the intervention clusters, Plan International identi ed three villages in which they were planning both a school-and community-based WASH programme. -For the control clusters, the research team and CVTL identi ed three schools suitable for a schoolbased WASH programme, located in a nearby district to the intervention communities.

Both males and females
Can healthy volunteers participate?

Key exclusion criteria
Exclusion criteria for enrollment in the study: -Not attending the primary school -Informed consent not obtained Exclusion criteria for receiving albendazole (including students enrolled in the study AND other members of communities in the intervention clusters): -Women in the rst trimester of pregnancy -Children under the age of 1 year

Study design
Purpose of the study

Allocation to intervention
Non-randomised trial Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) All children who are enrolled in and attending the primary school in each of the six communities participating in this pilot study will be eligible for inclusion in the study. Consent will be sought from parents/caregivers at a meeting which will be held at the school. Allocation is not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This pilot project is not randomised. This is because the WASH intervention for each arm of the study is being performed by a di erent NGO, and communities participating in the study are those in which those NGOs are working.

Masking / blinding
Open (masking not used)

Statistical methods / analysis
Descriptive statistics will be used to determine the proportion of eligible participants who gave informed consent, provided stool samples, completed questionnaires and underwent measurement of height and weight.
Primary and secondary outcomes will be calculated and compared across both arms of the trial using mixed e ects multivariate regression models that account for clustering of participants in villages.

Brief summary
The current WHO strategy for control of soil-transmitted helminths (STH) is school-based targeted drug treatment focusing on school-age children. Deworming programmes with anthelminthic drugs are highly e ective in reducing morbidity but rapid reinfection occurs if there is no reduction in environmental contamination with parasite infective stages. Therefore, provision of water, sanitation and hygiene (WASH) programs is of critical importance in the sustainable control of STHs. In fact, WASH programs have been shown to reduce worm infection, both when implemented at schools and in entire communities. On the other hand, recent modeling has raised questions about WHO guidelines, demonstrating limited impact from school-based delivery of interventions on community health and, importantly, STH transmission. This is contrary to the currently accepted idea that adults bene t from school-based deworming as a result of its impact on the overall intensity of transmission within the population. Therefore, when thinking of the long-term control of STH, it will be necessary to optimise strategies for deworming and WASH programs, with respect to school versus community-based delivery of interventions.
This pilot study aims to establish the feasibility of conducting a large cluster-randomised trial investigating the di erential impact of school-versus community-based integrated WASH and deworming programmes. The pilot study also aims to establish "proof of principle" that a communitybased intervention will be more e ective than a school-based intervention at reducing STH infections in school-aged children.

Trial website
Trial related presentations / publications