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

Conditions

Filariasis, Helminthiasis

Keywords

transmission interruption, intestinal nematodes, soil-transmitted helminths, mass drug administration, Benin, India, Malawi

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.

Malathi Manuel, Nils Pilotte, Joseph Timothy, Sean R. Galagan, Gideon John Israel et al. (23 authors)

Microbiology Spectrum2026-09-02

10.1128/spectrum.00363-26

Feasibility of interrupting the transmission of soil-transmitted helminths: the DeWorm3 community cluster-randomised controlled trial in Benin, India, and Malawi.

Ajjampur SSR, Aruldas K, Ásbjörnsdóttir KH, Avokpaho E, Bailey R, Cottrell G, Galagan SR, Halliday KE, Houngbégnon P, Ibikounlé 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.

2025-08-012 citations

10.1016/s0140-6736(25)00766-4

Coverage of community-wide mass drug administration platforms for soil-transmitted helminths in Benin, India, and Malawi: findings from the DeWorm3 project.

Means AR, Ásbjörnsdóttir 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, Ibikounlé M, Luty AJF, Ajjampur SSR, Walson JL.

2024-10-081 citations

10.1186/s40249-024-01241-0

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

Stefan Witek-McManus, James Simwanza, R. Msiska, Hastings Mangawah, William E. Oswald et al. (17 authors)

BMJ Open2024-09-01

10.1136/bmjopen-2023-083321

“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

Malvika Saxena, Amy Roll, Judd L. Walson, Emily Pearman, Hugo Legge et al. (18 authors)

PLoS neglected tropical diseases2024-02-064 citations

10.1371/journal.pntd.0011819

Identifying opportunities to optimize mass drug administration for soil-transmitted helminths: A visualization and descriptive analysis using process mapping

Eileen Kazura, Jabaselvi Johnson, Chloe Morozoff, Kumudha Aruldas, Euripide Avokpaho et al. (19 authors)

PLoS neglected tropical diseases2024-01-04

10.1371/journal.pntd.0011772

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

Rohan Michael Ramesh, William E. Oswald, Gideon John Israel, Kumudha Aruldas, Sean R. Galagan et al. (10 authors)

BMJ Open2023-10-011 citations

10.1136/bmjopen-2022-070077

Overestimation of school-based deworming coverage resulting from school-based reporting

William Sheahan, Roy M. Anderson, Kumudha Aruldas, Euripide Avokpaho, Sean R. Galagan et al. (26 authors)

PLoS neglected tropical diseases2023-04-104 citations

10.1371/journal.pntd.0010401

Impact of adverse events during community-wide mass drug administration for soil-transmitted helminths on subsequent participation–a Theory of Planned Behaviour analysis

Kumudha Aruldas, Gideon John Israel, Jabaselvi Johnson, Angelin Titus, Malvika Saxena et al. (10 authors)

PLoS neglected tropical diseases2023-03-142 citations

10.1371/journal.pntd.0011148

Evaluation of opportunities to implement community-wide mass drug administration for interrupting transmission of soil-transmitted helminths infections in India

Kumudha Aruldas, Kim A. Dawson, Malvika Saxena, Angelin Titus, Jabaselvi Johnson et al. (12 authors)

PLoS neglected tropical diseases2023-03-109 citations

10.1371/journal.pntd.0011176

Policy stakeholder perspectives on barriers and facilitators to launching a community-wide mass drug administration program for soil-transmitted helminths

Amy Roll, Malvika Saxena, Elizabeth Orlan, Angelin Titus, Sanjay Juvekar et al. (17 authors)

Global Health Research and Policy2022-12-029 citations

10.1186/s41256-022-00281-z

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

Chloe Morozoff, Euripide Avokpaho, Saravanakumar Puthupalayam Kaliappan, James Simwanza, Samuel Paul Gideon et al. (17 authors)

BMJ Open2022-07-017 citations

10.1136/bmjopen-2021-059565

It depends on how you tell: a qualitative diagnostic analysis of the implementation climate for community-wide mass drug administration for soil-transmitted helminth

Euripide Avokpaho, Sarah Lawrence, Amy Roll, Angelin Titus, Yesudoss Jacob et al. (17 authors)

BMJ Open2022-06-016 citations

10.1136/bmjopen-2022-061682

Factors associated with soil-transmitted helminths infection in Benin: Findings from the DeWorm3 study

Euripide Avokpaho, Parfait Houngbégnon, Manfred Accrombessi, Eloïc Atindégla, Elodie Yard et al. (16 authors)

PLoS neglected tropical diseases2021-08-1733 citations

10.1371/journal.pntd.0009646

Structural readiness to implement community-wide mass drug administration programs for soil-transmitted helminth elimination: results from a three-country hybrid study.

Means AR, Orlan E, Gwayi-Chore MC, Titus A, Kaliappan SP, Togbevi CI, Chabi F, Halliday KE, Nindi P, Avokpaho E, Kalua K, Ibikounlé M, Ajjampur SSR, Weiner BJ, Walson JL, Aruldas K.

2021-07-197 citations

10.1186/s43058-021-00164-3

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

Katya Galactionova, Maitreyi Sahu, Samuel Paul Gideon, Saravanakumar Puthupalayam Kaliappan, Chloe Morozoff et al. (9 authors)

BMJ Open2021-07-015 citations

10.1136/bmjopen-2021-049734

Epidemiology of soil-transmitted helminths following sustained implementation of routine preventive chemotherapy: Demographics and baseline results of a cluster randomised trial in southern Malawi

Stefan Witek-McManus, James Simwanza, Alvin Chisambi, Stella Kepha, Zachariah Kamwendo et al. (21 authors)

PLoS neglected tropical diseases2021-05-1220 citations

10.1371/journal.pntd.0009292

Epidemiology of soil transmitted helminths and risk analysis of hookworm infections in the community: Results from the DeWorm3 Trial in southern India

Sitara Swarna Rao Ajjampur, Saravanakumar Puthupalayam Kaliappan, Katherine E. Halliday, Gokila Palanisamy, Jasmine Farzana et al. (20 authors)

PLoS neglected tropical diseases2021-04-3046 citations

10.1371/journal.pntd.0009338

Baseline patterns of infection in regions of Benin, Malawi and India seeking to interrupt transmission of soil transmitted helminths (STH) in the DeWorm3 trial

The DeWorm3 Trials Team

PLoS neglected tropical diseases2020-11-0232 citations

10.1371/journal.pntd.0008771

Assessing the feasibility of interrupting the transmission of soil-transmitted helminths through mass drug administration: The DeWorm3 cluster randomized trial protocol

Kristjana Ásbjörnsdóttir, Sitara Swarna Rao Ajjampur, Roy M. Anderson, Robin L. Bailey, Iain Gardiner et al. (22 authors)

PLoS neglected tropical diseases2018-01-18154 citations

10.1371/journal.pntd.0006166

Interventions

DRUGAlbendazole

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Masking description

Mass drug administration intervention is not blinded to study participants but investigators and outcome assessors remain blind to link between allocation and outcome data

Eligibility

Sex/Gender

ALL

Age

12 Months to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Benin, India, Malawi

Contacts

PRINCIPAL_INVESTIGATORJudd L Walson, MD, MPH

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

Participant flow

Recruitment details

All participants were approached during a baseline census and offered the opportunity to participant in the study. Consent was taken from an adult household member for the entire household.

Pre-assignment details

Prior to restricted randomization, clusters were demarcated (40 per site) with 1650+ individuals following local administrative boundaries. Study clusters were then randomized to treatment arm by restricted randomization and followed for the study period. While the arms were at the cluster level, outcomes were assessed both at the cluster level and at the individual level by taking random samples among those living in the study clusters.

Baseline characteristics

Characteristic	—
Age, Customized Age category Adults (15+ years)	225902 Participants
Age, Customized Age category Infants (<1 year)	4337 Participants
Age, Customized Age category Pre-school-age children (1-4 years)	37125 Participants
Age, Customized Age category School-age children (5-14 years)	85533 Participants
Age, Customized Age category Unknown	423 Participants
Baseline STH prevalence: qPCR A. duodenale	23 Participants
Baseline STH prevalence: qPCR A. lumbricoides	141 Participants
Baseline STH prevalence: qPCR Any STH species	2368 Participants
Baseline STH prevalence: qPCR N. americanus	2288 Participants
Baseline STH prevalence: qPCR T. trichiura	19 Participants
Race/Ethnicity, Customized Language Majority language	168000 Participants
Race/Ethnicity, Customized Language Minority Language	8149 Participants
Race/Ethnicity, Customized Language Unknown	2266 Participants
Region of Enrollment Benin	94969 participants
Region of Enrollment India	141929 participants
Region of Enrollment Malawi	61007 participants
Sex/Gender, Customized Sex Female	92564 Participants
Sex/Gender, Customized Sex Male	87430 Participants
Sex/Gender, Customized Sex Other	6 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 242,344
other Total, other adverse events	0 / 242,344
serious Total, serious adverse events	13 / 242,344

Outcome results

None listed