Trial | NCT03014167  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    380000
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.
Study Started
Oct 04
2017
Primary Completion
Apr 30
2024
Anticipated
Study Completion
Apr 30
2024
Anticipated
Last Update
Nov 14
2022

Drug Albendazole

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

  • Other names: Albenza

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.

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.

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 Exclusion Criteria:

Less than 12 months of age
Individuals who do not typically reside in the study cluster
Nonconsenting or assenting individuals, as applicable
No Results Posted