Abstract
Current control strategies for soil-transmitted helminths (STH) emphasize morbidity control through mass drug administration (MDA) targeting preschool- and school-age children, women of childbearing age and adults in certain high-risk occupations such as agricultural laborers or miners. This strategy is effective at reducing morbidity in those treated but, without massive economic development, it is unlikely it will interrupt transmission. MDA will therefore need to continue indefinitely to maintain benefit. Mathematical models suggest that transmission interruption may be achievable through MDA alone, provided that all age groups are targeted with high coverage. The DeWorm3 Project will test the feasibility of interrupting STH transmission using biannual MDA targeting all age groups. Study sites (population ≥80,000) have been identified in Benin, Malawi and India. Each site will be divided into 40 clusters, to be randomized 1:1 to three years of twice-annual community-wide MDA or standard-of-care MDA, typically annual school-based deworming. Community-wide MDA will be delivered door-to-door, while standard-of-care MDA will be delivered according to national guidelines. The primary outcome is transmission interruption of the STH species present at each site, defined as weighted cluster-level prevalence ≤2% by quantitative polymerase chain reaction (qPCR), 24 months after the final round of MDA. Secondary outcomes include the endline prevalence of STH, overall and by species, and the endline prevalence of STH among children under five as an indicator of incident infections. Secondary analyses will identify cluster-level factors associated with transmission interruption. Prevalence will be assessed using qPCR of stool samples collected from a random sample of cluster residents at baseline, six months after the final round of MDA and 24 months post-MDA. A smaller number of individuals in each cluster will be followed with annual sampling to monitor trends in prevalence and reinfection throughout the trial.Trial registrationClinicalTrials.gov NCT03014167
Highlights
Author summarySoil-transmitted helminths (STH) affect 1.45 billion people worldwide, and high intensity infections are associated with anemia, undernutrition and impaired cognition, among children
The soil-transmitted helminths (STH) are group of intestinal parasites (Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus and Trichuris trichiura) targeted for control by the London Declaration
The DeWorm3 Project (ClinicalTrials.gov Identifier NCT03014167) will conduct a series of community cluster randomized trials in India, Malawi and Benin in order to determine whether continuing community-wide mass drug administration (MDA) with albendazole following cessation of lymphatic filariasis (LF) programs can interrupt the transmission of STH (Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus and Trichuris trichiura) in focal geographic areas
Summary
Soil-transmitted helminths (STH) affect 1.45 billion people worldwide, and high intensity infections are associated with anemia, undernutrition and impaired cognition, among children. Mathematical models suggest it may be possible to interrupt the transmission of STH in a community by expanding mass drug administration (MDA) from targeted high-risk groups (primarily school-aged children and women of child-bearing age) to all community members with high coverage. The DeWorm Project will test the feasibility of this approach to interrupting the transmission of STH using a series of cluster randomized trials in Benin, India and Malawi. Each study area (population !80,000) will be divided into 40 clusters and randomized to community-wide or standard-of-care targeted MDA for three years. Two years following the final round of MDA, prevalence of STH will be compared between arms and transmission interruption assessed in each cluster. The DeWorm trials will provide stakeholders with information regarding the potential to switch from STH control to a more ambitious and sustainable strategy
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