Skip to main content
Key Specialties
Anesthesiology Cardiology Dermatology Diabetology Endocrinology Gastroenterology General Medicine Geriatrics Hematology Infectious Diseases Internal Medicine Nephrology Neurology Obstetrics and Gynecology Oncology Pediatrics Psychiatry Radiology Respiratory Medicine Rheumatology Surgery Urology
Congress Coverage
2024 ESMO Congress 2024 ERS Congress 2024 EASD Congress 2024 ESC Congress 2024 EAN Congress 2024 ASCO Annual Meeting 2024 ACC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote series | Spotlight on menopause

Menopause can have a significant impact on the body, with effects ranging beyond the endocrine and reproductive systems. Learn about the systemic effects of menopause, so you can help patients in your clinics through the transition.

Launching: Thursday 12th December 2024
ADVANCED SEARCH
Log in
Top
Trials
Published in:

Open Access 01-12-2024 | Helminths | Study protocol

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

Authors: Mary Lorraine Mationg, Archie C. A. Clements, Gail M. Williams, Matthew Kelly, Donald E. Stewart, Catherine A. Gordon, Kinley Wangdi, Sirikachorn Tangkawattana, Apiporn T. Suwannatrai, Vanathom Savathdy, Visal Khieu, Sangduan Wannachart, Suji Yoo O’Connor, Simon Forsyth, Sean Gannon, Peter Odermatt, Donald P. McManus, Somphou Sayasone, Virak Khieu, Banchob Sripa, Darren J. Gray

Published in: Trials | Issue 1/2024

Login to get access

Abstract

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.
Appendix
Available only for authorised users
Literature
1.
2.
3.
Sripa B, Kaewkes S, Intapan PM, Maleewong W, Brindley PJ. Food-borne trematodiases in Southeast Asia epidemiology, pathology, clinical manifestation and control. Adv Parasitol. 2010;72:305–50.PubMedCrossRef
4.
Gebrie A, Alebel A. A systematic review and meta-analysis of the prevalence and predictors of anemia among children in Ethiopia. Afr Health Sci. 2020;20(4):2007–21.PubMedPubMedCentralCrossRef
5.
Geleto GE, Kassa T, Erko B. Epidemiology of soil-transmitted helminthiasis and associated malnutrition among under-fives in conflict affected areas in southern Ethiopia. Tropical Medicine and Health. 2022;50(1):44.PubMedPubMedCentralCrossRef
6.
Saldiva SR, Silveira AS, Philippi ST, Torres DM, Mangini AC, et al. AscarisTrichuris association and malnutrition in Brazilian children. Paediatr Perinat Epidemiol. 1999;13(1):89–98.PubMedCrossRef
7.
Bouvard V, Baan R, Straif K, Grosse Y, Secretan B, Ghissassi FE, et al. A review of human carcinogens—Part B: biological agents. Lancet Oncol. 2009;10(4):321–2.PubMedCrossRef
8.
Gizaw Z, Addisu A, Gebrehiwot M. Socioeconomic Predictors of Intestinal Parasitic Infections Among Under-Five Children in Rural Dembiya, Northwest Ethiopia: A Community-Based Cross-sectional Study. Environmental Health Insights. 2019;13:1178630219896804.PubMedPubMedCentralCrossRef
9.
Dhaka R, Verma R, Parmar A, Chayal V, Kalhan M, Bhalla K, et al. Association between the socioeconomic determinants and soil-transmitted helminthiasis among school-going children in a rural area of Haryana. Journal of Family Medicine and Primary Care. 2020;9(7):3712–5.PubMedPubMedCentralCrossRef
10.
Wattano S, Kerdpunya K, Keawphanuk P, Hunnangkul S, Loimak S, Tungtrongchitra A, et al. An Epidemiological Survey of Intestinal Parasitic Infection and the Socioeconomic Status of the Ethnic Minority People of Moken and Orang Laut. Tropical Medicine and Infectious Disease. 2023;8(3):161.PubMedPubMedCentralCrossRef
11.
Irum S, Ahsan A, Ahmed H, Khan A, Yayi G, Mehboob M, et al. A demographic survey on the prevalence of gastrointestinal parasites based on socioeconomic determinants in Pakistan. J Infect Dev Ctries. 2021;15(11):1738–43.PubMedCrossRef
12.
Wongsaroj T, Nithikathkul C, Rojkitikul W, Nakai W, Royal L, Rammasut P. National survey of helminthiasis in Thailand. Asian Biomedicine. 2014;8(6):779–83.CrossRef
13.
Martviset P, Phadungsil W, Na-Bangchang K, Sungkhabut W, Panupornpong T, Prathaphan P, et al. Current prevalence and geographic distribution of helminth infections in the parasitic endemic areas of rural Northeastern Thailand. BMC Public Health. 2023;23(1):448.PubMedPubMedCentralCrossRef
14.
Punsawad C, Phasuk N, Bunratsami S, Thongtup K, Viriyavejakul P, Palipoch S, et al. Prevalence of intestinal parasitic infections and associated risk factors for hookworm infections among primary schoolchildren in rural areas of Nakhon Si Thammarat, southern Thailand. BMC Public Health. 2018;18(1):1118.PubMedPubMedCentralCrossRef
15.
Kache R, Phasuk N, Viriyavejakul P, Punsawad C. Prevalence of soil-transmitted helminth infections and associated risk factors among elderly individuals living in rural areas of southern Thailand. BMC Public Health. 2020;20(1):1882.PubMedPubMedCentralCrossRef
16.
Kitvatanachai S, Taylor A, Rhongbutsri P, Taylor WRJ. Modified Harada-Mori and simple wet mount to determine hookworm infections in Yo Island urban area, Songkhla. Southern Thailand Trop Med Health. 2019;47:27.PubMedCrossRef
17.
18.
Kuong K, Fiorentino M, Perignon M, Chamnan C, Berger J, Sinuon M, et al. Cognitive Performance and Iron Status are Negatively Associated with Hookworm Infection in Cambodian Schoolchildren. Am J Trop Med Hyg. 2016;95(4):856–63.PubMedPubMedCentralCrossRef
19.
20.
Forrer A, Khieu V, Schar F, Vounatsou P, Chammartin F, Marti H, et al. Strongyloides stercoralis and hookworm co-infection: spatial distribution and determinants in Preah Vihear Province, Cambodia. Parasit Vectors. 2018;11(1):33.PubMedPubMedCentralCrossRef
21.
Sayasone S, Vonghajack Y, Vanmany M, Rasphone O, Tesana S, Utzinger J, et al. Diversity of human intestinal helminthiasis in Lao PDR. Trans R Soc Trop Med Hyg. 2009;103(3):247–54.PubMedCrossRef
22.
Sayasone S, Mak TK, Vanmany M, Rasphone O, Vounatsou P, Utzinger J, et al. Helminth and intestinal protozoa infections, multiparasitism and risk factors in Champasack province, Lao People’s Democratic Republic. PLoS Negl Trop Dis. 2011;5(4): e1037.PubMedPubMedCentralCrossRef
23.
Soukhathammavong PA, Sayasone S, Phongluxa K, Xayaseng V, Utzinger J, Vounatsou P, et al. Low efficacy of single-dose albendazole and mebendazole against hookworm and effect on concomitant helminth infection in Lao PDR. PLoS Negl Trop Dis. 2012;6(1):e1417.PubMedPubMedCentralCrossRef
24.
Conlan JV, Khamlome B, Vongxay K, Elliot A, Pallant L, Sripa B, et al. Soil-transmitted helminthiasis in Laos: a community-wide cross-sectional study of humans and dogs in a mass drug administration environment. Am J Trop Med Hyg. 2012;86(4):624–34.PubMedPubMedCentralCrossRef
25.
Forrer A, Vounatsou P, Sayasone S, Vonghachack Y, Bouakhasith D, Utzinger J, et al. Risk profiling of hookworm infection and intensity in southern Lao People’s Democratic Republic using Bayesian models. PLoS Negl Trop Dis. 2015;9(3):e0003486.PubMedPubMedCentralCrossRef
26.
Phongluxa K, Xayaseng V, Vonghachack Y, Akkhavong K, van Eeuwijk P, Odermatt P. Helminth infection in southern Laos: high prevalence and low awareness. Parasit Vectors. 2013;6(1):328.PubMedPubMedCentralCrossRef
27.
Eom KS, Yong TS, Sohn WM, Chai JY, Min DY, Rim HJ, et al. Prevalence of helminthic infections among inhabitants of Lao PDR. Korean J Parasitol. 2014;52(1):51–6.PubMedPubMedCentralCrossRef
28.
Pauly M, Sayasinh K, Muller CP, Sayasone S, Black AP. High prevalence of helminth infections in mother-child pairs from three central provinces of Lao People’s Democratic Republic. Parasite Epidemiol Control. 2019;7:e00122.PubMedPubMedCentralCrossRef
29.
Nanthavong N, Black AP, Khattignavong P, Lorphachan L, Vilivong K, Goossens S, et al. High prevalence of intestinal worms in children up to 5 years of age in Huaphan province, Lao People’s Democratic Republic (PDR). Parasite Epidemiol Control. 2017;2(3):114–7.PubMedPubMedCentralCrossRef
30.
Wattanawong O, Iamsirithaworn S, Kophachon T, Nak-ai W, Wisetmora A, Wongsaroj T, et al. Current status of helminthiases in Thailand: A cross-sectional, nationwide survey, 2019. Acta Trop. 2021;223:106082.PubMedCrossRef
31.
Khieu V, Furst T, Miyamoto K, Yong TS, Chai JY, Huy R, et al. Is Opisthorchis viverrini Emerging in Cambodia? Adv Parasitol. 2019;103:31–73.PubMedCrossRef
32.
Yong TS, Chai JY, Sohn WM, Eom KS, Jeoung HG, Hoang EH, et al. Prevalence of intestinal helminths among inhabitants of Cambodia (2006–2011). Korean J Parasitol. 2014;52(6):661–6.PubMedPubMedCentralCrossRef
33.
Zhao T-T, Feng Y-J, Doanh PN, Sayasone S, Khieu V, Nithikathkul C, et al. Model-based spatial-temporal mapping of opisthorchiasis in endemic countries of Southeast Asia. eLife. 2021;10:e59755.PubMedPubMedCentralCrossRef
34.
Kamsa-ard S, Santong C, Kamsa-ard S, Luvira V, Luvira V, Suwanrungruang K, et al. Decreasing trends in cholangiocarcinoma incidence and relative survival in Khon Kaen, Thailand: An updated, inclusive, population-based cancer registry analysis for 1989–2018. PLoS ONE. 2021;16(2):e0246490.PubMedPubMedCentralCrossRef
35.
Gad MM, Saad AM, Faisaluddin M, Gaman MA, Ruhban IA, Jazieh KA, et al. Epidemiology of Cholangiocarcinoma; United States Incidence and Mortality Trends. Clin Res Hepatol Gastroenterol. 2020;44(6):885–93.PubMedCrossRef
36.
37.
38.
39.
Jia T-W, Melville S, Utzinger J, King CH, Zhou X-N. Soil-transmitted helminth reinfection after drug treatment: a systematic review and meta-analysis. PLoS Negl Trop Dis. 2012;6(5):e1621.PubMedPubMedCentralCrossRef
40.
Upatham ES, Viyanant V, Brockelman WY, Kurathong S, Lee P, Kraengraeng R. Rate of re-infection by Opisthorchis viverrini in an endemic northeast Thai community after chemotherapy. Int J Parasitol. 1988;18(5):643–9.PubMedCrossRef
41.
Sithithaworn P, Ziegler AD, Grundy-Warr C, Andrews RH, Petney TN. Changes to the life cycle of liver flukes: dams, roads, and ponds. Lancet Infect Dis. 2012;12(8):588.PubMedCrossRef
42.
Sornmani S, Vivatanasesth P, Impand P, Phatihatakorn W, Sitabutra P, Schelp FP. Infection and re-infection rates of opisthorchiasis in the water resource development area of Nam Pong project, Khon Kaen Province, northeast Thailand. Ann Trop Med Parasitol. 1984;78(6):649–56.PubMedCrossRef
43.
Kaplan RM, Vidyashankar AN. An inconvenient truth: Global worming and anthelmintic resistance. Vet Parasitol. 2012;186(1–2):70–8.PubMedCrossRef
44.
Albonico M. Methods to sustain drug efficacy in helminth control programmes. Acta Trop. 2003;86(2–3):233–42.PubMedCrossRef
45.
Albonico M, Engels D, Savioli L. Monitoring drug efficacy and early detection of drug resistance in human soil-transmitted nematodes: a pressing public health agenda for helminth control. Int J Parasitol. 2004;34(11):1205–10.PubMedCrossRef
46.
Keiser J, Utzinger J. The drugs we have and the drugs we need against major helminth infections. Adv Parasitol. 2010;73:197–230.PubMedCrossRef
47.
Kamsa-Ard S, Luvira V, Pugkhem A, Luvira V, Thinkhamrop B, Suwanrungruang K, et al. Association between praziquantel treatment and cholangiocarcinoma: a hospital-based matched case-control study. BMC Cancer. 2015;15:776.PubMedPubMedCentralCrossRef
48.
Chudthaisong N, Promthet S, Bradshaw P. Risk factors for Opisthorchis viverrini Infection in Nong Khai Province. Thailand Asian Pac J Cancer Prev. 2015;16(11):4593–6.PubMedCrossRef
49.
Lier T, Do DT, Johansen MV, Nguyen TH, Dalsgaard A, Asfeldt AM. High reinfection rate after preventive chemotherapy for fishborne zoonotic trematodes in Vietnam. PLoS Negl Trop Dis. 2014;8(6):e2958.PubMedPubMedCentralCrossRef
50.
Thinkhamrop K, Khuntikeo N, Sithithaworn P, Thinkhamrop W, Wangdi K, Kelly MJ, et al. Repeated praziquantel treatment and Opisthorchis viverrini infection: a population-based cross-sectional study in northeast Thailand. Infect Dis Poverty. 2019;8(1):18.PubMedPubMedCentralCrossRef
51.
Bieri FA, Gray DJ, Williams GM, Raso G, Li Y-S, Yuan L, et al. Health-education package to prevent worm infections in Chinese schoolchildren. N Engl J Med. 2013;368(17):1603–12.PubMedCrossRef
52.
53.
Sripa B, Tangkawattana S, Sangnikul T. The Lawa model: A sustainable, integrated opisthorchiasis control program using the EcoHealth approach in the Lawa Lake region of Thailand. Parasitol Int. 2017;66(4):346–54.PubMedCrossRef
54.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.PubMedPubMedCentralCrossRef
55.
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.PubMedPubMedCentralCrossRef
56.
Elkins DB, Haswell-Elkins M, Anderson RM. The epidemiology and control of intestinal helminths in the Pulicat Lake region of Southern India. I. Study design and pre- and post-treatment observations on Ascaris lumbricoides infection. Trans R Soc Trop Med Hyg. 1986;80(5):774–92.PubMedCrossRef
57.
Pinlaor S, Onsurathum S, Boonmars T, Pinlaor P, Hongsrichan N, Chaidee A, et al. Distribution and abundance of Opisthorchis viverrini metacercariae in cyprinid fish in Northeastern Thailand. Korean J Parasitol. 2013;51(6):703–10.PubMedPubMedCentralCrossRef
58.
Miyamoto K, Kirinoki M, Matsuda H, Hayashi N, Chigusa Y, Sinuon M, et al. Field survey focused on Opisthorchis viverrini infection in five provinces of Cambodia. Parasitol Int. 2014;63(2):366–73.PubMedCrossRef
59.
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019;95:103208.PubMedPubMedCentralCrossRef
60.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.PubMedCrossRef
61.
Metadata
Title
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
Authors
Mary Lorraine Mationg
Archie C. A. Clements
Gail M. Williams
Matthew Kelly
Donald E. Stewart
Catherine A. Gordon
Kinley Wangdi
Sirikachorn Tangkawattana
Apiporn T. Suwannatrai
Vanathom Savathdy
Visal Khieu
Sangduan Wannachart
Suji Yoo O’Connor
Simon Forsyth
Sean Gannon
Peter Odermatt
Donald P. McManus
Somphou Sayasone
Virak Khieu
Banchob Sripa
Darren J. Gray
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-08616-6

Other articles of this Issue 1/2024

PLUS-IS-LESS project: Procalcitonin and Lung UltraSonography-based antibiotherapy in patients with Lower rESpiratory tract infection in Swiss Emergency Departments: study protocol for a pragmatic stepped-wedge cluster-randomized trial

Towards an understanding of the ethics of electronic consent in clinical trials

  • Open Access
  • Commentary

Comparison between the mesenteric fixation method (MEFIX) and conventional methods at preventing the occurrence of Petersen’s hernia: a study protocol for a multicenter randomized controlled trial

Correction: Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized controlled trial according to the Trials within Cohorts design

  • Open Access
  • Correction

Application of the patient-reported outcome-based postoperative symptom management model in lung cancer: a multicenter randomized controlled trial protocol

Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan