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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Natural History Museum, United Kingdom

Current Primary Outcome: STH transmission interruption [ 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Natural History Museum, United Kingdom

Dates:
Date Received: December 30, 2016
Date Started: March 2017
Date Completion: December 2022
Last Updated: March 15, 2017
Last Verified: March 2017