Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-06 @ 10:42 AM
Study NCT ID:
NCT03014167
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2016-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)
Sponsor:
Organization:
Raw JSON
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Feasibility of interrupting the transmission of soil-transmitted helminths: the DeWorm3 community cluster-randomised controlled trial in Benin, India, and Malawi. Lancet. 2025 Aug 2;406(10502):475-488. doi: 10.1016/S0140-6736(25)00766-4.'}, {'pmid': '39380086', 'type': 'DERIVED', 'citation': 'Means AR, Asbjornsdottir KH, Sharrock KC, Galagan SR, Aruldas K, Avokpaho E, Chabi F, Halliday KE, Houngbegnon P, Israel GJ, Kaliappan SP, Kennedy D, Legge H, Oswald WE, Palanisamy G, Rogers E, Timothy J, Pearman E, Ramesh RM, Simwanza J, Sheik-Abdullah JF, Sheikh M, Togbevi CI, Witek-McManus S, Pullan RL, Bailey R, Kalua K, Ibikounle M, Luty AJF, Ajjampur SSR, Walson JL. Coverage of community-wide mass drug administration platforms for soil-transmitted helminths in Benin, India, and Malawi: findings from the DeWorm3 project. Infect Dis Poverty. 2024 Oct 8;13(1):72. doi: 10.1186/s40249-024-01241-0.'}, {'pmid': '39242171', 'type': 'DERIVED', 'citation': 'Witek-McManus S, Simwanza J, Msiska R, Mangawah H, Oswald W, Timothy J, Galagan S, Pearman E, Shaikh M, Legge H, Walson J, Juziwelo L, Davey C, Pullan R, Bailey RL, Kalua K, Kuper H. Disability in childhood and the equity of health services: a cross-sectional comparison of mass drug administration strategies for soil-transmitted helminths in southern Malawi. BMJ Open. 2024 Sep 5;14(9):e083321. doi: 10.1136/bmjopen-2023-083321.'}, {'pmid': '38319937', 'type': 'DERIVED', 'citation': 'Saxena M, Roll A, Walson JL, Pearman E, Legge H, Nindi P, Chirambo CM, Titus A, Johnson J, Belou EA, Togbevi CI, Chabi F, Avokpaho E, Kalua K, Ajjampur SSR, Ibikounle M, Aruldas K, Means AR. "Our desire is to make this village intestinal worm free": Identifying determinants of high coverage of community-wide mass drug administration for soil transmitted helminths in Benin, India, and Malawi. PLoS Negl Trop Dis. 2024 Feb 6;18(2):e0011819. doi: 10.1371/journal.pntd.0011819. eCollection 2024 Feb.'}, {'pmid': '38175837', 'type': 'DERIVED', 'citation': 'Kazura E, Johnson J, Morozoff C, Aruldas K, Avokpaho E, Togbevi CI, Chabi F, Gwayi-Chore MC, Nindi P, Titus A, Houngbegnon P, Kaliappan SP, Jacob Y, Simwanza J, Kalua K, Walson JL, Ibikounle M, Ajjampur SSR, Means AR. Identifying opportunities to optimize mass drug administration for soil-transmitted helminths: A visualization and descriptive analysis using process mapping. PLoS Negl Trop Dis. 2024 Jan 4;18(1):e0011772. doi: 10.1371/journal.pntd.0011772. eCollection 2024 Jan.'}, {'pmid': '37899143', 'type': 'DERIVED', 'citation': 'Ramesh RM, Oswald WE, Israel GJ, Aruldas K, Galagan S, Legge H, Puthupalayam Kaliappan S, Walson J, Halliday KE, Ajjampur SSR. Representativeness of a mobile phone-based coverage evaluation survey following mass drug administration for soil-transmitted helminths: a comparison of participation between two cross-sectional surveys. BMJ Open. 2023 Oct 29;13(10):e070077. doi: 10.1136/bmjopen-2022-070077.'}, {'pmid': '37036890', 'type': 'DERIVED', 'citation': 'Sheahan W, Anderson R, Aruldas K, Avokpaho E, Galagan S, Goodman J, Houngbegnon P, Israel GJ, Janagaraj V, Kaliappan SP, Means AR, Morozoff C, Pearman E, Ramesh RM, Roll A, Schaefer A, Simwanza J, Witek-McManus S, Ajjampur SSR, Bailey R, Ibikounle M, Kalua K, Luty AJF, Pullan R, Walson JL, Asbjornsdottir KH. Overestimation of school-based deworming coverage resulting from school-based reporting. PLoS Negl Trop Dis. 2023 Apr 10;17(4):e0010401. doi: 10.1371/journal.pntd.0010401. eCollection 2023 Apr.'}, {'pmid': '36917597', 'type': 'DERIVED', 'citation': 'Aruldas K, Israel GJ, Johnson J, Titus A, Saxena M, Kaliappan SP, Ramesh RM, Walson JL, Means AR, Ajjampur SSR. Impact of adverse events during community-wide mass drug administration for soil-transmitted helminths on subsequent participation-a Theory of Planned Behaviour analysis. PLoS Negl Trop Dis. 2023 Mar 14;17(3):e0011148. doi: 10.1371/journal.pntd.0011148. eCollection 2023 Mar.'}, {'pmid': '36897877', 'type': 'DERIVED', 'citation': 'Aruldas K, Dawson K, Saxena M, Titus A, Johnson J, Gwayi-Chore MC, Muliyil J, Kang G, Walson JL, Khera A, Ajjampur SSR, Means AR. Evaluation of opportunities to implement community-wide mass drug administration for interrupting transmission of soil-transmitted helminths infections in India. PLoS Negl Trop Dis. 2023 Mar 10;17(3):e0011176. doi: 10.1371/journal.pntd.0011176. eCollection 2023 Mar.'}, {'pmid': '36461087', 'type': 'DERIVED', 'citation': 'Roll A, Saxena M, Orlan E, Titus A, Juvekar SK, Gwayi-Chore MC, Avokpaho E, Chabi F, Togbevi CI, Belou Elijan A, Nindi P, Walson JL, Ajjampur SSR, Ibikounle M, Kalua K, Aruldas K, Means AR. Policy stakeholder perspectives on barriers and facilitators to launching a community-wide mass drug administration program for soil-transmitted helminths. Glob Health Res Policy. 2022 Dec 2;7(1):47. doi: 10.1186/s41256-022-00281-z.'}, {'pmid': '35803632', 'type': 'DERIVED', 'citation': 'Morozoff C, Avokpaho E, Puthupalayam Kaliappan S, Simwanza J, Gideon SP, Lungu W, Houngbegnon P, Galactionova K, Sahu M, Kalua K, Luty AJF, Ibikounle M, Bailey R, Pullan R, Ajjampur SSR, Walson J, Means AR. Costs of community-wide mass drug administration and school-based deworming for soil-transmitted helminths: evidence from a randomised controlled trial in Benin, India and Malawi. BMJ Open. 2022 Jul 8;12(7):e059565. doi: 10.1136/bmjopen-2021-059565.'}, {'pmid': '35701056', 'type': 'DERIVED', 'citation': 'Avokpaho E, Lawrence S, Roll A, Titus A, Jacob Y, Puthupalayam Kaliappan S, Gwayi-Chore MC, Chabi F, Togbevi CI, Elijan AB, Nindi P, Walson JL, Ajjampur SSR, Ibikounle M, Kalua K, Aruldas K, Means AR. It depends on how you tell: a qualitative diagnostic analysis of the implementation climate for community-wide mass drug administration for soil-transmitted helminth. BMJ Open. 2022 Jun 14;12(6):e061682. doi: 10.1136/bmjopen-2022-061682.'}, {'pmid': '34403424', 'type': 'DERIVED', 'citation': 'Avokpaho EFGA, Houngbegnon P, Accrombessi M, Atindegla E, Yard E, Rubin Means A, Kennedy DS, Littlewood DTJ, Garcia A, Massougbodji A, Galagan SR, Walson JL, Cottrell G, Ibikounle M, Asbjornsdottir KH, Luty AJF. Factors associated with soil-transmitted helminths infection in Benin: Findings from the DeWorm3 study. PLoS Negl Trop Dis. 2021 Aug 17;15(8):e0009646. doi: 10.1371/journal.pntd.0009646. eCollection 2021 Aug.'}, {'pmid': '34281614', 'type': 'DERIVED', 'citation': 'Means AR, Orlan E, Gwayi-Chore MC, Titus A, Kaliappan SP, Togbevi CI, Chabi F, Halliday KE, Nindi P, Avokpaho E, Kalua K, Ibikounle M, Ajjampur SSR, Weiner BJ, Walson JL, Aruldas K. Structural readiness to implement community-wide mass drug administration programs for soil-transmitted helminth elimination: results from a three-country hybrid study. Implement Sci Commun. 2021 Jul 19;2(1):80. doi: 10.1186/s43058-021-00164-3.'}, {'pmid': '34226233', 'type': 'DERIVED', 'citation': 'Galactionova K, Sahu M, Gideon SP, Puthupalayam Kaliappan S, Morozoff C, Ajjampur SSR, Walson J, Rubin Means A, Tediosi F. Costing interventions in the field: preliminary cost estimates and lessons learned from an evaluation of community-wide mass drug administration for elimination of soil-transmitted helminths in the DeWorm3 trial. BMJ Open. 2021 Jul 5;11(7):e049734. doi: 10.1136/bmjopen-2021-049734.'}, {'pmid': '33979325', 'type': 'DERIVED', 'citation': 'Witek-McManus S, Simwanza J, Chisambi AB, Kepha S, Kamwendo Z, Mbwinja A, Samikwa L, Oswald WE, Kennedy DS, Timothy JWS, Legge H, Galagan SR, Emmanuel-Fabula M, Schaer F, Asbjornsdottir K, Halliday KE, Walson JL, Juziwelo L, Bailey RL, Kalua K, Pullan RL. Epidemiology of soil-transmitted helminths following sustained implementation of routine preventive chemotherapy: Demographics and baseline results of a cluster randomised trial in southern Malawi. PLoS Negl Trop Dis. 2021 May 12;15(5):e0009292. doi: 10.1371/journal.pntd.0009292. eCollection 2021 May.'}, {'pmid': '33930024', 'type': 'DERIVED', 'citation': 'Ajjampur SSR, Kaliappan SP, Halliday KE, Palanisamy G, Farzana J, Manuel M, Abraham D, Laxmanan S, Aruldas K, Rose A, Kennedy DS, Oswald WE, Pullan RL, Galagan SR, Asbjornsdottir K, Anderson RM, Muliyil J, Sarkar R, Kang G, Walson JL. Epidemiology of soil transmitted helminths and risk analysis of hookworm infections in the community: Results from the DeWorm3 Trial in southern India. PLoS Negl Trop Dis. 2021 Apr 30;15(4):e0009338. doi: 10.1371/journal.pntd.0009338. eCollection 2021 Apr.'}, {'pmid': '33137100', 'type': 'DERIVED', 'citation': 'DeWorm3 Trials Team. Baseline patterns of infection in regions of Benin, Malawi and India seeking to interrupt transmission of soil transmitted helminths (STH) in the DeWorm3 trial. PLoS Negl Trop Dis. 2020 Nov 2;14(11):e0008771. doi: 10.1371/journal.pntd.0008771. eCollection 2020 Nov.'}, {'pmid': '29346377', 'type': 'DERIVED', 'citation': 'Asbjornsdottir KH, Ajjampur SSR, Anderson RM, Bailey R, Gardiner I, Halliday KE, Ibikounle M, Kalua K, Kang G, Littlewood DTJ, Luty AJF, Means AR, Oswald W, Pullan RL, Sarkar R, Schar F, Szpiro A, Truscott JE, Werkman M, Yard E, Walson JL; DeWorm3 Trials Team. Assessing the feasibility of interrupting the transmission of soil-transmitted helminths through mass drug administration: The DeWorm3 cluster randomized trial protocol. PLoS Negl Trop Dis. 2018 Jan 18;12(1):e0006166. doi: 10.1371/journal.pntd.0006166. eCollection 2018 Jan.'}], 'seeAlsoLinks': [{'url': 'http://deworm3.org', 'label': 'University of Washington DeWorm3 Website'}]}, 'descriptionModule': {'briefSummary': 'Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children and school-age children. However mathematical models suggests that current MDA strategies are not sufficient for interrupting disease transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have successfully treated entire populations with albendazole (in combination with ivermectin or diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project will conduct a series of community-based cluster randomized trials in India, Malawi, and Benin to determine if maintaining three years of MDA with albendazole to entire communities following the cessation of LF programs can interrupt STH transmission in focal geographic areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus targeted MDA of children in interrupting the transmission of STH. Nested implementation science research will be used to optimize the intervention, identify contextual factors influencing trial efficacy, and evaluate the feasibility of sustaining and scaling community-wide MDA for STH. These data will provide evidence necessary to inform future guidelines, policies, and operational plans as country partners engage in intensified approaches to eliminate these disabling diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Treatment Inclusion Criteria:\n\n* Ages 12 months and older\n\nTreatment Exclusion Criteria:\n\n* Children under 12 months of age\n* Pregnant women in their first trimester\n* History of adverse reaction to benzimidazoles\n\nOutcome Sampling Inclusion Criteria:\n\n* Resident of study clusters\n* Ages 12 months and older\n* Willingness of adult aged 18 years and above (or age as per country specific ethical guidelines) or parent/guardian of child to provide written informed consent\n* Provision of written assent to participate from children aged 8 years and above (or age as per country specific ethical guidelines)\n\nOutcome Sampling Exclusion Criteria:\n\n* Less than 12 months of age\n* Individuals who do not typically reside in the study cluster\n* Nonconsenting or assenting individuals, as applicable'}, 'identificationModule': {'nctId': 'NCT03014167', 'briefTitle': 'Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project', 'orgStudyIdInfo': {'id': 'STUDY00000180'}, 'secondaryIdInfos': [{'id': '1R01AI155739-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AI155739-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Community-wide deworming', 'description': 'Twice-yearly community-wide treatment delivered by drug distributors door to door or via community gatherings, depending upon the format of the prior LF program, for three years. All individuals above the age of 12 months will receive a single dose of albendazole.', 'interventionNames': ['Drug: Albendazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Targeted deworming', 'description': 'Pre-school (pre-SAC) and school-age children (SAC) 12 months of age and older will receive albendazole delivered in accordance with national Ministry of Health guidelines for three years.', 'interventionNames': ['Drug: Albendazole']}], 'interventions': [{'name': 'Albendazole', 'type': 'DRUG', 'otherNames': ['Albenza'], 'description': 'All eligible individuals will receive a single dose of 400 mg albendazole.', 'armGroupLabels': ['Community-wide deworming', 'Targeted deworming']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Comé', 'country': 'Benin', 'facility': 'Institut de Recherche pour le Développement', 'geoPoint': {'lat': 6.40764, 'lon': 1.88198}}, {'city': 'Vellore', 'country': 'India', 'facility': 'Christian Medical College', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'city': 'Mangochi', 'country': 'Malawi', 'facility': 'London School of Hygiene and Tropical Medicine', 'geoPoint': {'lat': -14.47815, 'lon': 35.26448}}], 'overallOfficials': [{'name': 'Judd L Walson, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington, Departments of Global Health, Medicine (Infectious Disease), Pediatrics and Epidemiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}, {'name': 'Imperial College London', 'class': 'OTHER'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, {'name': 'Institut de Recherche Clinique du Bénin (IRCB)', 'class': 'UNKNOWN'}, {'name': 'Institut de Recherche pour le Developpement', 'class': 'OTHER_GOV'}, {'name': 'Christian Medical College, Vellore, India', 'class': 'OTHER'}, {'name': 'Blantyre Institute for Community Ophthalmology (BICO)', 'class': 'UNKNOWN'}, {'name': 'Swiss Tropical & Public Health Institute', 'class': 'OTHER'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Departments of Global Health, Medicine (Infectious Disease), Pediatrics and Epidemiology', 'investigatorFullName': 'Judd Walson', 'investigatorAffiliation': 'University of Washington'}}}}