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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
357,716
All eligible individuals will receive a single dose of 400 mg albendazole.
Institut de Recherche pour le Développement
Comé, Benin
Christian Medical College
Vellore, India
London School of Hygiene and Tropical Medicine
Mangochi, Malawi
Comparison of Arms - Benin
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Time frame: 5 years (Three years of drug administration and two years of surveillance)
Comparison of Arms - India
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Time frame: 5 years (Three years of drug administration and two years of surveillance)
Comparison of Arms - Malawi
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Time frame: 5 years (Three years of drug administration and two years of surveillance)
N. Americanus Transmission Interruption - Benin
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
N. Americanus Transmission Interruption - India
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
N. Americanus Transmission Interruption - Malawi
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
N. Americanus Transmission Interruption - Pooled
Prevalence of N. americanus infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
Comparison of Arms - Pooled
Individual-level soil-transmitted helminth species-specific endline quantitative PCR prevalence
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Pooled
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Benin
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - India
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
STH Transmission Interruption - Malawi
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time frame: 5 years (Three years of drug administration and two years of surveillance)
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