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

• Sponsor: University of Washington (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03014167
• Collaborator: Bill and Melinda Gates Foundation (Other), Imperial College London (Other), London School of Hygiene and Tropical Medicine (Other), Institut de Recherche Clinique du Bénin (IRCB) (Other), Institut de Recherche pour le Developpement (Other), Christian Medical College, Vellore, India (Other), Blantyre Institute for Community Ophthalmology (BICO) (Other), Swiss Tropical & Public Health Institute (Other)
• Enrollment: 380,000
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 73.9
• Patients Per Site: 126666.7
• Patients Per Site Per Month: 1714.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Helminthiasis; Filariasis	Drug: Albendazole	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 380000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Mass drug administration intervention is not blinded to study participants but investigators and outcome assessors remain blind to link between allocation and outcome data
• Primary Purpose: Treatment
• Official Title: Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project
• Actual Study Start Date: Oct 4, 2017
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Community-wide deworming 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.	Drug: Albendazole; All eligible individuals will receive a single dose of 400 mg albendazole.; Other Names: Albenza
Active Comparator: Targeted deworming 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.	Drug: Albendazole; All eligible individuals will receive a single dose of 400 mg albendazole.; Other Names: Albenza

Outcome Measures

Primary Outcome Measures

1. STH transmission interruption [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Recherche pour le Développement	Comé		Benin
2	Christian Medical College	Vellore		India
3	London School of Hygiene and Tropical Medicine	Mangochi		Malawi

Sponsors and Collaborators

• University of Washington
• Bill and Melinda Gates Foundation
• Imperial College London
• London School of Hygiene and Tropical Medicine
• Institut de Recherche Clinique du Bénin (IRCB)
• Institut de Recherche pour le Developpement
• Christian Medical College, Vellore, India
• Blantyre Institute for Community Ophthalmology (BICO)
• Swiss Tropical & Public Health Institute

Investigators

• Principal Investigator: Judd L Walson, MD, MPH, University of Washington Department of Global Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Washington DeWorm3 Website

Publications

None provided.

• Responsible Party: Judd Walson, Professor: Global Health, Allergy and Infectious Diseases, Epidemiology, Public Health, Pediatrics, University of Washington
• ClinicalTrials.gov Identifier: NCT03014167
• Other Study ID Numbers: STUDY00000180
• First Posted: Jan 9, 2017
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Judd Walson, Professor: Global Health, Allergy and Infectious Diseases, Epidemiology, Public Health, Pediatrics, University of Washington: transmission interruption; intestinal nematodes; soil-transmitted helminths; mass drug administration; Benin; India; Malawi
• Additional relevant MeSH terms: Filariasis; Helminthiasis; Albendazole

Study Results

No Results Posted as of Apr 1, 2021