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NCT Number: NCT03014167

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

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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Key information

Conditions

Helminthiasis Filariasis Infections Nematode Infections Parasitic Diseases Secernentea Infections Spirurida Infections

Age range

12 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut de Recherche pour le Développement, Comé, Benin

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albendazole

Drug

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

Other names: Albenza

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. N. Americanus Transmission Interruption - Pooled

    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

  2. Comparison of Arms - Pooled

    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

  3. STH Transmission Interruption - Pooled

    Time frame: 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

  4. STH Transmission Interruption - Benin

    Time frame: 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

  5. STH Transmission Interruption - India

    Time frame: 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

  6. STH Transmission Interruption - Malawi

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Blantyre Institute for Community Ophthalmology (BICO)
  • Christian Medical College, Vellore, India
  • Imperial College London
  • Institut de Recherche Clinique du Benin
  • Institut de Recherche pour le Developpement
  • London School of Hygiene and Tropical Medicine
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Swiss Tropical & Public Health Institute

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2017
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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