TY - JOUR
T1 - A study protocol for a multi-country cluster randomized controlled trial of the impact of a multi-component One Health strategy to eliminate Opisthorchis viverrini and soil transmitted helminths in the Lower Mekong Basin
AU - Mationg, Mary Lorraine
AU - Clements, Archie C.A.
AU - Williams, Gail M.
AU - Kelly, Matthew
AU - Stewart, Donald E.
AU - Gordon, Catherine A.
AU - Wangdi, Kinley
AU - Tangkawattana, Sirikachorn
AU - Suwannatrai, Apiporn T.
AU - Savathdy, Vanathom
AU - Khieu, Visal
AU - Wannachart, Sangduan
AU - O’Connor, Suji Yoo
AU - Forsyth, Simon
AU - Gannon, Sean
AU - Odermatt, Peter
AU - McManus, Donald P.
AU - Sayasone, Somphou
AU - Khieu, Virak
AU - Sripa, Banchob
AU - Gray, Darren J.
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
KW - Health education
KW - Integrated control
KW - Lawa Model
KW - Magic Glasses
KW - Mass drug administration
KW - Opisthorchis viverrini
KW - Randomized controlled trial
KW - Soil-transmitted helminths
UR - http://www.scopus.com/inward/record.url?scp=85210583860&partnerID=8YFLogxK
U2 - 10.1186/s13063-024-08616-6
DO - 10.1186/s13063-024-08616-6
M3 - Article
C2 - 39605028
AN - SCOPUS:85210583860
SN - 1745-6215
VL - 25
JO - Trials
JF - Trials
M1 - 801
ER -