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

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

DRUG

Albendazole

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

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Institut de Recherche Clinique du Bénin (IRCB)

  collaborator UNKNOWN

• Institut de Recherche pour le Developpement

  collaborator OTHER_GOV

• Christian Medical College, Vellore, India

  collaborator OTHER

• Blantyre Institute for Community Ophthalmology (BICO)

  collaborator UNKNOWN

• Swiss Tropical & Public Health Institute

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Judd L Walson, MD, MPH · University of Washington, Departments of Global Health, Medicine (Infectious Disease), Pediatrics and Epidemiology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-10-04

Primary Completion

2024-07-02

Completion

2024-07-02

FDA Drug

Yes

Countries

• Benin
• India
• Malawi

Study Locations