NCT03014167

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 357,716 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Helminthiasis
• Filariasis

Interventions

Type	Name	Description
DRUG	Albendazole	All eligible individuals will receive a single dose of 400 mg albendazole.

Timeline

• Start date: 2017-10-04
• Primary completion: 2024-07-02
• Completion: 2024-07-02
• First posted: 2017-01-09
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

3 sites across 3 countries: Benin, India, Malawi

Regulatory

• FDA-regulated drug study