Clinical trial NCT03014167: Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH)
Official title: Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Helminthiasis
Filariasis
Keywords: transmission interruption
intestinal nematodes
soil-transmitted helminths
mass drug administration
Benin
India
Malawi
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Imperial College London
name: London School of Hygiene and Tropical Medicine
name: Institut de Recherche Clinique du Bénin (IRCB)
name: Institut de Recherche pour le Developpement
name: Christian Medical College, Vellore, India
name: Blantyre Institute for Community Ophthalmology (BICO)
name: Swiss Tropical & Public Health Institute
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2017-01-09
Enrollment: 502363
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: STH transmission interruption
timeFrame: 5 years (Three years of drug administration and two years of surveillance)
Secondary outcomes:
Other outcomes:
Locations:
city: Comé
country: Benin
facility: Institut de Recherche pour le Développement
city: Vellore
country: India
facility: Christian Medical College
city: Mangochi
country: Malawi
facility: London School of Hygiene and Tropical Medicine
Study officials:
affiliation: University of Washington, Departments of Global Health, Medicine (Infectious Disease), Pediatrics and Epidemiology
name: Judd L Walson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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