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

Study Overview
=================
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.

Official Title
-----------------
Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project

Conditions
-----------------
Filariasis, Helminthiasis

Intervention / Treatment
-----------------
* Drug: Albendazole


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community-wide deworming<br>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<br>* All eligible individuals will receive a single dose of 400 mg albendazole.<br>* Other names: Albenza;|
| Active Comparator: Targeted deworming<br>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<br>* All eligible individuals will receive a single dose of 400 mg albendazole.<br>* Other names: Albenza;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STH transmission interruption | Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole | 5 years (Three years of drug administration and two years of surveillance) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transmission interruption, intestinal nematodes, soil-transmitted helminths, mass drug administration, Benin, India, Malawi