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

University of Washington

Status and phase: Completed; Phase 3

Conditions: Filariasis; Helminthiasis

Treatments: Drug: Albendazole

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03014167

1R01AI155739-01A1 (U.S. NIH Grant/Contract)

STUDY00000180

Details and patient eligibility

About

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.

Enrollment: 357,716 patients

Sex: All

Ages: 12+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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357,716 participants in 2 patient groups

Community-wide deworming

Experimental group

Description:

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.

Treatment:

Drug: Albendazole

Targeted deworming

Active Comparator group

Description:

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.

Treatment:

Drug: Albendazole