NCT03014167

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357,716

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_3

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

October 4, 2017

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2024

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

July 1, 2025

Enrollment Period

6.7 years

First QC Date

December 30, 2016

Results QC Date

June 10, 2025

Last Update Submit

January 5, 2026

Conditions

HelminthiasisFilariasis

Keywords

transmission interruptionintestinal nematodessoil-transmitted helminthsmass drug administrationBeninIndiaMalawi

Outcome Measures

Primary Outcomes (6)

  • Comparison of Arms - Benin

    Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence

    5 years (Three years of drug administration and two years of surveillance)

  • Comparison of Arms - India

    Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence

    5 years (Three years of drug administration and two years of surveillance)

  • Comparison of Arms - Malawi

    Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence

    5 years (Three years of drug administration and two years of surveillance)

  • N. Americanus Transmission Interruption - Benin

    Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole

    5 years (Three years of drug administration and two years of surveillance)

  • N. Americanus Transmission Interruption - India

    Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole

    5 years (Three years of drug administration and two years of surveillance)

  • N. Americanus Transmission Interruption - Malawi

    Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole

    5 years (Three years of drug administration and two years of surveillance)

Secondary Outcomes (6)

  • N. Americanus Transmission Interruption - Pooled

    5 years (Three years of drug administration and two years of surveillance)

  • Comparison of Arms - Pooled

    5 years (Three years of drug administration and two years of surveillance)

  • STH Transmission Interruption - Pooled

    5 years (Three years of drug administration and two years of surveillance)

  • STH Transmission Interruption - Benin

    5 years (Three years of drug administration and two years of surveillance)

  • STH Transmission Interruption - India

    5 years (Three years of drug administration and two years of surveillance)

  • +1 more secondary outcomes

Study Arms (2)

Community-wide deworming

EXPERIMENTAL

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.

Drug: Albendazole

Targeted deworming

ACTIVE COMPARATOR

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.

Drug: Albendazole

Interventions

AlbendazoleDRUG

All eligible individuals will receive a single dose of 400 mg albendazole.

Also known as: Albenza
Community-wide dewormingTargeted deworming

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 12 months and older

You may not qualify if:

  • Children under 12 months of age
  • Pregnant women in their first trimester
  • History of adverse reaction to benzimidazoles
  • 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)
  • Less than 12 months of age
  • Individuals who do not typically reside in the study cluster
  • Nonconsenting or assenting individuals, as applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institut de Recherche pour le Développement

Comé, Benin

Location

Christian Medical College

Vellore, India

Location

London School of Hygiene and Tropical Medicine

Mangochi, Malawi

Location

Related Publications (19)

  • 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: 40752908DERIVED

  • 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: 39380086DERIVED

  • 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: 39242171DERIVED

  • 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: 38319937DERIVED

  • 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: 38175837DERIVED

  • 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: 37899143DERIVED

  • 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: 37036890DERIVED

  • 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: 36917597DERIVED

  • 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: 36897877DERIVED

  • 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: 36461087DERIVED

  • 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: 35803632DERIVED

  • 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: 35701056DERIVED

  • 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: 34403424DERIVED

  • 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: 34281614DERIVED

  • 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: 34226233DERIVED

  • 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: 33979325DERIVED

  • 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: 33930024DERIVED

  • 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: 33137100DERIVED

  • 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: 29346377DERIVED

Related Links

MeSH Terms

Conditions

HelminthiasisFilariasis

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Parasitic DiseasesInfectionsSpirurida InfectionsSecernentea InfectionsNematode Infections

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Judd Walson
Organization
Johns Hopkins University Bloomberg School of Public Health
jwalson1@jh.edu
2066124571

Study Officials

  • Judd L Walson, MD, MPH

    University of Washington, Departments of Global Health, Medicine (Infectious Disease), Pediatrics and Epidemiology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Mass drug administration intervention is not blinded to study participants but investigators and outcome assessors remain blind to link between allocation and outcome data
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Departments of Global Health, Medicine (Infectious Disease), Pediatrics and Epidemiology

Study Record Dates

First Submitted

December 30, 2016

First Posted

January 9, 2017

Study Start

October 4, 2017

Primary Completion

July 2, 2024

Study Completion

July 2, 2024

Last Updated

January 22, 2026

Results First Posted

January 22, 2026

Record last verified: 2025-07

Locations

BE(1)IN(1)MA(1)