HelminthiasisPhase 3NCT03014167

Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)

A Phase 3 study testing Albendazole in people with Helminthiasis and Filariasis, run by University of Washington at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 months and olderHealthy volunteers can take part
Conditions the study is for: Helminthiasis, Filariasis
What is being tested?: Albendazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 357,716 participants
Where: 3 sitesin 3 countries
Study dates: 4 Oct 2017to 2 Jul 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Benin1 site

Institut de Recherche pour le Développement
Comé

Other trials in Benin

India1 site

Christian Medical College
Vellore

Other trials in India

Malawi1 site

London School of Hygiene and Tropical Medicine
Mangochi

Other trials in Malawi

About this study

Official title: Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project

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.

Conditions: Helminthiasis, Filariasis
Being tested: Albendazole
Keywords: transmission interruption, intestinal nematodes, soil-transmitted helminths, mass drug administration, Benin, India, Malawi
Medical subject headings: Helminthiasis, Filariasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlbendazoleDrug
Also called Albenza
All eligible individuals will receive a single dose of 400 mg albendazole.

Study groups in NCT03014167
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Albendazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of Arms - Benin
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 years (Three years of drug administration and two years of surveillance)

Secondary outcomes (6)

N. Americanus Transmission Interruption - Pooled
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Measured: 5 years (Three years of drug administration and two years of surveillance)
Comparison of Arms - Pooled
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Measured: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Pooled
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Measured: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Benin
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Measured: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - India
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Measured: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Malawi
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Measured: 5 years (Three years of drug administration and two years of surveillance)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 20172 Jul 2024

First posted9 Jan 2017 (estimated)
Study start4 Oct 2017
Primary completion2 Jul 2024
Study completion2 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (21)Papers the sponsor has linked to this study.
Other trials for HelminthiasisStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 357,716 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03014167
Sponsor's protocol ID: STUDY00000180
Other IDs: 1R01AI155739-01A1
Status last verified: Jul 2025
First submitted: 30 Dec 2016
Last updated: 22 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 42684913
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.
PubMed 42264499
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.
PubMed 40752908
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.
PubMed 39380086
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.
PubMed 39242171
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.
PubMed 38319937
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.
PubMed 38175837
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.
PubMed 37899143
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.
PubMed 37036890
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.
PubMed 36917597
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.
PubMed 36897877
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.
PubMed 36461087
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.
PubMed 35803632
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.
PubMed 35701056
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.
PubMed 34403424

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Natural History of Treated Neurocysticercosis and Long-Term Outcomes
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Not yet recruitingPhase 3
Follow-up Assessment of Change in Soil-transmitted Helminths Infection Intensity in Uganda
Ascariasis
RecruitingPhase 3
Better Options for Lymphatic Filariasis Treatment
Lymphatic Filariasis, Scabies

All Helminthiasis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project
ClinicalTrials.gov ID: NCT03014167
Acronym / sponsor ID: STUDY00000180
Conditions: Helminthiasis, Filariasis
Keywords: transmission interruption, intestinal nematodes, soil-transmitted helminths, mass drug administration, Benin, India, Malawi
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 357,716 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or 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)
Study start: 4 Oct 2017 (actual)
Primary completion: 2 Jul 2024 (actual)
Study completion: 2 Jul 2024 (actual)
First posted: 9 Jan 2017 (estimated)
Results: Posted 22 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Community-wide deworming	Experimental	Drug: AlbendazoleTwice-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: AlbendazolePre-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.

Who may qualify

Ages: 12 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlbendazoleAlso: AlbenzaAll eligible individuals will receive a single dose of 400 mg albendazole.	Drug	Community-wide deworming, Targeted deworming

Primary outcome

Comparison of Arms - Benin
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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

6 secondary outcomes

N. Americanus Transmission Interruption - Pooled
Time frame: 5 years (Three years of drug administration and two years of surveillance)
Comparison of Arms - Pooled
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Pooled
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Benin
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - India
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Malawi
Time frame: 5 years (Three years of drug administration and two years of surveillance)

Results and safety

Results posted to the registry on 22 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Community-wide Deworming (Intervention)	177,705	119,342
School-age-targeted Deworming (Control)	179,207	116,665

Primary outcome: Comparison of Arms - Benin

Time frame: 5 years (Three years of drug administration and two years of surveillance). Count of participants. Unit: Participants

Measure	Community-wide Deworming (Intervention) n = 18490	School-age-targeted Deworming (Control) n = 18673
N. americanus: N americanus	322	748
A duodenale: N americanus	11	11
A lumbricoides: N americanus	123	59
T trichiura: N americanus	13	6
Any STH species: N americanus	467	819

Population analysed: The number of participants analyzed is the number surveyed and sampled at endline

Primary outcome: Comparison of Arms - India

Time frame: 5 years (Three years of drug administration and two years of surveillance). Count of participants. Unit: Participants

Measure	Community-wide Deworming (Intervention) n = 19894	School-age-targeted Deworming (Control) n = 19896
N. americanus (primary)	1906 (0.32 to 0.52)	4310
A. duodenale	3 (0.17 to 4.94)	3
A. lumbricoides	17 (0.81 to 5.29)	7
T. trichiura	7 (0.34 to 2.67)	5
Any STH species	1930 (0.33 to 0.52)	4318 (na to na)

Population analysed: The number of participants analyzed is the number surveyed and sampled at endline

Primary outcome: Comparison of Arms - Malawi

Time frame: 5 years (Three years of drug administration and two years of surveillance). Count of participants. Unit: Participants

Measure	Community-wide Deworming (Intervention) n = 20170	School-age-targeted Deworming (Control) n = 20258
N. americanus (primary)	827 (0.34 to 0.46)	1989 (na to na)
A. duodenale	6 (0.07 to 1.40)	15 (na to na)
A. lumbricoides	12 (0.37 to 1.38)	15 (na to na)
T. trichiura	2 (0.03 to 2.63)	4 (na to na)
Any STH species	846 (0.35 to 0.47)	2016 (na to na)

Population analysed: The number of participants analyzed is the number surveyed and sampled at endline

Primary outcome: N. Americanus Transmission Interruption - Benin

Time frame: 5 years (Three years of drug administration and two years of surveillance). Count of units. Unit: Study clusters

Measure	Community-wide Deworming (Intervention) n = 18490	School-age-targeted Deworming (Control) n = 18673
Transmission interruption	11	6
Did not achieve transmission interruption	9	14

Population analysed: The age- and sex-weighted prevalence of N. americanus was calculated at the cluster level and defined as transmission interruption if the bound of the one-side 95% confidence interval was \<2%.

6 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Community-wide Deworming (Intervention)	13 of 242,344 (0%)	0 of 242,344 (0%)	0 of 242,344

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42684913Manuel 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.
Derived from this study: PubMed 42264499Chen 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.
Derived from this study: PubMed 40752908Ajjampur 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.
Derived from this study: PubMed 39380086Means 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.
Derived from this study: PubMed 39242171Witek-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.
Derived from this study: PubMed 38319937Saxena 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.
Derived from this study: PubMed 38175837Kazura 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.
Derived from this study: PubMed 37899143Ramesh 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.
Derived from this study: PubMed 37036890Sheahan 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.
Derived from this study: PubMed 36917597Aruldas 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.
Derived from this study: PubMed 36897877Aruldas 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.
Derived from this study: PubMed 36461087Roll 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.
University of Washington DeWorm3 WebsiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Judd L Walson, MD, MPH principal investigator

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

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Albendazole in people with Helminthiasis and Filariasis, run by University of Washington at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Benin, India, Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Arms - Benin (time frame: 5 years (Three years of drug administration and two years of surveillance)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03014167, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.