Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project
| Registry | NCT03014167 |
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| Status | Completed |
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| Phase | Phase 3 |
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| Study type | Interventional; randomized, parallel, masking: double, treatment |
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| Enrollment | 357716 (Actual) |
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| Sponsor | University of Washington (Other); collaborators: Bill and Melinda Gates Foundation, Imperial College London, London School of Hygiene and Tropical Medicine, Institut de Recherche Clinique du Benin, Institut de Recherche pour le Developpement, Christian Medical College, Vellore, India, Blantyre Institute for Community Ophthalmology (BICO), Swiss Tropical & Public Health Institute, National Institute of Allergy and Infectious Diseases (NIAID) |
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| Conditions | Helminthiasis, Filariasis |
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| Interventions | Albendazole (Drug) |
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| Dates | start 2017-10-04, primary completion 2024-07-02, completion 2024-07-02, first posted 2017-01-09, last updated 2026-01-22 |
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| Locations | 3 sites in Benin, India, Malawi |
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-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Community-wide deworming | Experimental | Drug: Albendazole | 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. |
| Targeted deworming | Active comparator | Drug: Albendazole | 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. |
- Albendazole (Drug), also known as Albenza: All eligible individuals will receive a single dose of 400 mg albendazole.
+Outcome measures
Primary outcomes
- Comparison of Arms - Benin [5 years (Three years of drug administration and two years of surveillance)]: Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
- Comparison of Arms - India [5 years (Three years of drug administration and two years of surveillance)]: Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
- Comparison of Arms - Malawi [5 years (Three years of drug administration and two years of surveillance)]: Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
- N. Americanus Transmission Interruption - Benin [5 years (Three years of drug administration and two years of surveillance)]: Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
- N. Americanus Transmission Interruption - India [5 years (Three years of drug administration and two years of surveillance)]: Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
- N. Americanus Transmission Interruption - Malawi [5 years (Three years of drug administration and two years of surveillance)]: Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Secondary outcomes
- N. Americanus Transmission Interruption - Pooled [5 years (Three years of drug administration and two years of surveillance)]: Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
- Comparison of Arms - Pooled [5 years (Three years of drug administration and two years of surveillance)]: Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
- STH Transmission Interruption - Pooled [5 years (Three years of drug administration and two years of surveillance)]: Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
- STH Transmission Interruption - Benin [5 years (Three years of drug administration and two years of surveillance)]: Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
- STH Transmission Interruption - India [5 years (Three years of drug administration and two years of surveillance)]: Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
- STH Transmission Interruption - Malawi [5 years (Three years of drug administration and two years of surveillance)]: Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
+Eligibility
Sex: All, ages: 12 Months to any, accepts healthy volunteers
Treatment Inclusion Criteria:
* Ages 12 months and older
Treatment Exclusion Criteria:
* Children under 12 months of age
* Pregnant women in their first trimester
* History of adverse reaction to benzimidazoles
Outcome Sampling Inclusion Criteria:
* Resident of study clusters
* Ages 12 months and older
* 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
* Provision of written assent to participate from children aged 8 years and above (or age as per country specific ethical guidelines)
Outcome Sampling Exclusion Criteria:
* Less than 12 months of age
* Individuals who do not typically reside in the study cluster
* Nonconsenting or assenting individuals, as applicable
+Posted results
Participant flow
| Milestone | Community-wide Deworming (Intervention) | School-age-targeted Deworming (Control) |
|---|
| Started | 177705 | 179207 |
| Completed | 119342 | 116665 |
| Not completed | 58363 | 62542 |
Outcome results
- N. Americanus Transmission Interruption - Pooled (Secondary), Count of units, Study clusters: Community-wide Deworming (Intervention) 12; School-age-targeted Deworming (Control) 6
- Comparison of Arms - Pooled (Secondary), Count of participants, Participants: Community-wide Deworming (Intervention) 3055 (0.36 to 0.48); School-age-targeted Deworming (Control) 7047
- Comparison of Arms - Benin (Primary), Count of participants, Participants: Community-wide Deworming (Intervention) 322; School-age-targeted Deworming (Control) 748
- Comparison of Arms - India (Primary), Count of participants, Participants: Community-wide Deworming (Intervention) 1906 (0.32 to 0.52); School-age-targeted Deworming (Control) 4310
- Comparison of Arms - Malawi (Primary), Count of participants, Participants: Community-wide Deworming (Intervention) 827 (0.34 to 0.46); School-age-targeted Deworming (Control) 1989 (na to na)
- N. Americanus Transmission Interruption - Benin (Primary), Count of units, Study clusters: Community-wide Deworming (Intervention) 11; School-age-targeted Deworming (Control) 6
- N. Americanus Transmission Interruption - India (Primary), Count of units, Study clusters: Community-wide Deworming (Intervention) 1; School-age-targeted Deworming (Control) 0
- STH Transmission Interruption - Pooled (Secondary), Count of units, Study clusters: Community-wide Deworming (Intervention) 9; School-age-targeted Deworming (Control) 5
- STH Transmission Interruption - Benin (Secondary), Count of units, Study clusters: Community-wide Deworming (Intervention) 9; School-age-targeted Deworming (Control) 5
- STH Transmission Interruption - India (Secondary), Count of units, Study clusters: Community-wide Deworming (Intervention) 0; School-age-targeted Deworming (Control) 0
- STH Transmission Interruption - Malawi (Secondary), Count of units, Study clusters: Community-wide Deworming (Intervention) 0; School-age-targeted Deworming (Control) 0
- N. Americanus Transmission Interruption - Malawi (Primary), Count of units, Study clusters: Community-wide Deworming (Intervention) 0; School-age-targeted Deworming (Control) 0
Adverse events
Time frame: 2 years, 9 months. Treatment with albendazole is known to be safe and billions of doses have been distributed over the previous decades. Therefore, a comparison between arms was not an objective of the study and adverse events were only collected to reduce the risk of harm to research subjects. Therefore, adverse events were passively ascertained during rounds of mass drug administration contacted the study staff and a study clinician reviewed and responded to adverse events.
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Community-wide Deworming (Intervention) | 0/242344 (0.0%) | 13/242344 (0.0%) | 0/242344 (0.0%) |
Serious adverse events by term
| Term | Organ system | Community-wide Deworming (Intervention) |
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| Viral fever | Gastrointestinal disorders | 1/242344 |
| Acute gastroenteritis | Gastrointestinal disorders | 3/242344 |
| Fainting | General disorders | 4/242344 |
| Fever / malaria | Infections and infestations | 4/242344 |
| Impacted bowel | Gastrointestinal disorders | 1/242344 |
+Locations (3)
| Facility | City | Country | Status |
|---|
| Institut de Recherche pour le Développement | Comé | Benin | |
| Christian Medical College | Vellore | India | |
| London School of Hygiene and Tropical Medicine | Mangochi | Malawi | |
+Publications
- Results publication: Manuel M, Pilotte N, Timothy JWS, Galagan SR, Israel GJ, Connors CT, Omballa V, Voss MP, Dadwal UC, Gonzalez AM, Ahlonsou J, Chaima D, Zondervenni Manoharan Z, Rains D, Asbjornsdottir KH, Williams SA, Luty AJF, Ibikounle M, Kalua K, Bailey RL, Pullan RL, Walson JL, Ajjampur SSR. Determination of diagnostic cycle threshold cutoffs for qPCR-based prevalence surveys of soil-transmitted helminth infections. Microbiol Spectr. 2026 Sep 2:e0036326. doi: 10.1128/spectrum.00363-26. Online ahead of print. PMID 42684913
- Results publication: Chen S, Ramesh RM, Aruldas K, Kaliappan SP, Chandy BR, Koshy B, Jasper S, Halliday KE, Walson JL, Oswald W, Ajjampur SSR, Kuper H. Disparities in deworming coverage between children with and without disabilities: insights from the DeWorm3 trial in India. BMJ Glob Health. 2026 Jun 9;11(6):e020531. doi: 10.1136/bmjgh-2025-020531. PMID 42264499
- Results publication: Ajjampur SSR, Aruldas K, Asbjornsdottir KH, Avokpaho E, Bailey R, Cottrell G, Galagan SR, Halliday KE, Houngbegnon P, Ibikounle M, Israel GJ, Kaliappan SP, Kalua K, Legge H, Littlewood DTJ, Luty AJF, Manuel M, Massougbodji A, Means AR, Oswald WE, Pilotte N, Pullan R, Ramesh RM, Samikwa L, Simwanza J, Thomas KK, Williams SA, Witek-McManus S, Walson JL; DeWorm3 Trials Team. 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 40752908
- Results publication: 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 39380086
- Results publication: 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 39242171
- Results publication: 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 38319937
- Results publication: 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 38175837
- Results publication: 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 37899143
- Results publication: 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 37036890
- Results publication: 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 36917597
- Results publication: 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 36897877
- Results publication: 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 36461087
- Results publication: 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 35803632
- Results publication: 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 35701056
- Results publication: 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 34403424
- Results publication: 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 34281614
- Results publication: 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 34226233
- Results publication: 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 33979325
- Results publication: 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 33930024
- Results publication: 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 33137100
- Results publication: 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. PMID 29346377
+Study documents
+Investigators
- Judd L Walson, MD, MPH, Principal investigator, University of Washington, Departments of Global Health, Medicine (Infectious Disease), Pediatrics and Epidemiology
+Funding