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Background: Opisthorchis viverrini (OV) and soil-transmitted helminths (STH) are two of the most common helminths contributing to the Neglected Tropical Disease (NTDs) burden in the Lower Mekong Basin. Although mass drug administration is the cornerstone of control programs to reduce morbidity caused by these infections, this approach has limitations in preventing re-infections. Elimination requires additional measures such as reservoir host treatment, improved hygiene and health education to reinforce MDA's impact. This study aims to examine the impact of a scalable multi-component One Health Helminth Elimination program in the Lower Mekong Basin (HELM) that combines human praziquantel (PZQ) and albendazole (ALB) treatment with a program that includes the "Magic Glasses" and the "Lawa Model" interventions with health promotion at their core., Methods: This study will employ a cluster randomized controlled trial (cRCT) in 18 rural communities (with sub-district or villages as cluster units) across Cambodia, Laos and Thailand. The control arm will receive one round of PZQ/ALB treatment, while in the intervention arm, multi-component HELM program will be implemented, which includes PZQ/ALB treatment together with the Magic Glasses and Lawa Model interventions. OV and STH infections levels will be evaluated in individuals aged 5-75 years at baseline and will be repeated at follow-up (12 months after the HELM intervention), using modified formalin ethyl-acetate concentration technique and quantitative PCR. The primary outcome of the study will be cumulative incidence of human OV and STH infections. Outcomes between the study arms will be compared using generalized linear mixed models, accounting for clustering., Discussion: Evidence from this trial will quantify the impact of a multi-component One Health control strategy in interrupting Ov and STH infections in the Lower Mekong Basin., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622000353796. Prospectively registered 28 February 2022., Competing Interests: Declarations. Ethics approval and consent to participate: This study was submitted to and received ethical approval from the Australian National University Human Research Ethics Committee (Protocol number 2022/507), Cambodia Ministry of Health National Ethics Committee for Health Research (NECHR) (209NECHR), the Lao PDR Ministry NECHR (07NCEHR) and Khon Kaen University Ethics Committee for Human Research (Reference No. HE651147). This study is prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622000353796. Participation in the survey will be voluntary. Informed consent will be obtained from all participants ≥ 18 years old. Inclusion of participants < 18 years old required consent from a parent or guardian and assent from individuals 5 to 17 years old. The study objectives, intervention components, voluntary participation and the right to withdraw at any time will be verbally elaborated and outlined in the information sheet. Two copies will be signed by the study participants: an original copy and a duplicate. Researchers will keep the original copies of the consents signed by the study participants and leave the duplicate copies with them for their own records. This trial will also involve collection of stool specimens for storage. If the study participants will not allow the storage and use of remaining stool samples for future research, the remaining samples will be disposed immediately after the completion of all the procedures of this study. This study also obtained ethical approval from the Australian National University Animal Ethics Committee (Protocol Number A2022/27) and Institutional Animal Care and Use Committee of Khon Kaen University (Reference No. 660201.2.11/245 (39)). Consent for publication: Not applicable—there are no personal information or identifying images of study participants are presented here or will be presented in reports of the trial results. Competing interests: The authors declare that they have no competing interests., (© 2024. The Author(s).)

Background: Helminths are a major global health issue, impacting health, educational, and socioeconomic outcomes. Infections, often starting in childhood, are linked to anemia, malnutrition, cognitive deficit, and in chronic cases of Opisthorchis viverrini (OV), cholangiocarcinoma. The main control strategy for helminth infection is mass drug administration; however, this does not prevent reinfection. As such, prevention strategies are needed. The "Magic Glasses" is a school-based cartoon health education package that has demonstrated success in improving knowledge, attitudes, and practices (KAP) surrounding soil-transmitted helminths (STH) in China and the Philippines. This study is designed to assess the acceptability and impact of the 2 new versions of the Magic Glasses targeting STH and OV designed for the Lower Mekong audience in Cambodia, Lao People's Democratic Republic (PDR), and Thailand., Objective: The objective of this study is to evaluate the acceptability of the "Magic Glasses Lower Mekong" and "Magic Glasses Opisthorchiasis" education packages among schoolchildren in the Lower Mekong Basin, and the impact of these education packages on students' KAP surrounding STH and OV, respectively., Methods: Schoolchildren will be recruited into a cluster randomized controlled trial with intervention and control arms in rural schools in Cambodia, Lao PDR, and Thailand. Schoolchildren's initial acceptability of the intervention will be evaluated using an adapted questionnaire. Sustained acceptability will be assessed at 9-month follow-up through focus group discussions with students and interviews with teachers. Impact will be evaluated by KAP questionnaires on STH and OV. KAP questionnaires will be administered to children at baseline and at follow-up. Indirect impact on parents' KAP of OV and STH will be assessed through focus group discussions at follow-up., Results: The trial is in progress in Lao PDR and Thailand and is expected to commence in Cambodia in January 2024. The results of the study are expected to be available 18 months from the start of recruitment. We hypothesize that participants enrolled in the intervention arm of the study will have higher KAP scores for STH and OV, compared with the participants in the control arm at follow-up. We expect that students will have initial and sustained acceptability of these intervention packages., Conclusions: This trial will examine the acceptability of the "Magic Glasses Opisthorchiasis" and "Magic Glasses Lower Mekong" interventions and provide evidence on the effectiveness of the "Magic Glasses" on KAP related to OV and STH among schoolchildren in the Lower Mekong Basin. Study results will provide insight on acceptability and impact indicators and inform a scaling up protocol for the "Magic Glasses" education packages in Cambodia, Lao PDR, and Thailand., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12623000271606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385315&isReview=true., International Registered Report Identifier (irrid): DERR1-10.2196/55290., (©Suji Y O'Connor, Mary Lorraine Mationg, Matthew J Kelly, Gail M Williams, Archie CA Clements, Banchob Sripa, Somphou Sayasone, Virak Khieu, Kinley Wangdi, Donald E Stewart, Sirikachorn Tangkawattana, Apiporn T Suwannatrai, Vanthanom Savathdy, Visal Khieu, Peter Odermatt, Catherine A Gordon, Sangduan Wannachart, Donald P McManus, Darren J Gray. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 16.09.2024.)