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

Primary Purpose

Helminthiasis, Filariasis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Albendazole
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helminthiasis focused on measuring transmission interruption, intestinal nematodes, soil-transmitted helminths, mass drug administration, Benin, India, Malawi

Eligibility Criteria

12 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institut de Recherche pour le DéveloppementRecruiting
  • Christian Medical CollegeRecruiting
  • London School of Hygiene and Tropical MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Community-wide deworming

Targeted deworming

Arm 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.

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.

Outcomes

Primary Outcome Measures

STH transmission interruption
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole

Secondary Outcome Measures

Full Information

First Posted
December 30, 2016
Last Updated
November 4, 2022
Sponsor
University of Washington
Collaborators
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, National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT03014167
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
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, National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helminthiasis, Filariasis
Keywords
transmission interruption, intestinal nematodes, soil-transmitted helminths, mass drug administration, Benin, India, Malawi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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
Allocation
Randomized
Enrollment
380000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Community-wide deworming
Arm Type
Experimental
Arm 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.
Arm Title
Targeted deworming
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Albendazole
Other Intervention Name(s)
Albenza
Intervention Description
All eligible individuals will receive a single dose of 400 mg albendazole.
Primary Outcome Measure Information:
Title
STH transmission interruption
Description
Prevalence of STH infection ≤2% 24 months following the final round of mass drug administration with albendazole
Time Frame
5 years (Three years of drug administration and two years of surveillance)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judd L Walson, MD, MPH
Phone
206-744-3695
Ext
43695
Email
walson@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Arianna Means, PhD, MPH
Email
aerubin@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judd L Walson, MD, MPH
Organizational Affiliation
University of Washington Department of Global Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Recherche pour le Développement
City
Comé
Country
Benin
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Luty, PhD, DR
Email
adrian.luty@ird.fr
Facility Name
Christian Medical College
City
Vellore
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gagandeep Kang, MBBS, MD, PhD
Email
gkang@cmcvellore.ac.in
Facility Name
London School of Hygiene and Tropical Medicine
City
Mangochi
Country
Malawi
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Bailey, MA, BM, MRCP, DTM&H, PhD, FRCP
Email
robin.bailey@lshtm.ac.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
35803632
Citation
Morozoff C, Avokpaho E, Puthupalayam Kaliappan S, Simwanza J, Gideon SP, Lungu W, Houngbegnon P, Galactionova K, Sahu M, Kalua K, Luty AJF, Ibikounle M, Bailey R, Pullan R, Ajjampur SSR, Walson J, Means AR. Costs of community-wide mass drug administration and school-based deworming for soil-transmitted helminths: evidence from a randomised controlled trial in Benin, India and Malawi. BMJ Open. 2022 Jul 8;12(7):e059565. doi: 10.1136/bmjopen-2021-059565.
Results Reference
derived
PubMed Identifier
35701056
Citation
Avokpaho E, Lawrence S, Roll A, Titus A, Jacob Y, Puthupalayam Kaliappan S, Gwayi-Chore MC, Chabi F, Togbevi CI, Elijan AB, Nindi P, Walson JL, Ajjampur SSR, Ibikounle M, Kalua K, Aruldas K, Means AR. It depends on how you tell: a qualitative diagnostic analysis of the implementation climate for community-wide mass drug administration for soil-transmitted helminth. BMJ Open. 2022 Jun 14;12(6):e061682. doi: 10.1136/bmjopen-2022-061682.
Results Reference
derived
PubMed Identifier
34403424
Citation
Avokpaho EFGA, Houngbegnon P, Accrombessi M, Atindegla E, Yard E, Rubin Means A, Kennedy DS, Littlewood DTJ, Garcia A, Massougbodji A, Galagan SR, Walson JL, Cottrell G, Ibikounle M, Asbjornsdottir KH, Luty AJF. Factors associated with soil-transmitted helminths infection in Benin: Findings from the DeWorm3 study. PLoS Negl Trop Dis. 2021 Aug 17;15(8):e0009646. doi: 10.1371/journal.pntd.0009646. eCollection 2021 Aug.
Results Reference
derived
PubMed Identifier
34281614
Citation
Means AR, Orlan E, Gwayi-Chore MC, Titus A, Kaliappan SP, Togbevi CI, Chabi F, Halliday KE, Nindi P, Avokpaho E, Kalua K, Ibikounle M, Ajjampur SSR, Weiner BJ, Walson JL, Aruldas K. Structural readiness to implement community-wide mass drug administration programs for soil-transmitted helminth elimination: results from a three-country hybrid study. Implement Sci Commun. 2021 Jul 19;2(1):80. doi: 10.1186/s43058-021-00164-3.
Results Reference
derived
PubMed Identifier
34226233
Citation
Galactionova K, Sahu M, Gideon SP, Puthupalayam Kaliappan S, Morozoff C, Ajjampur SSR, Walson J, Rubin Means A, Tediosi F. Costing interventions in the field: preliminary cost estimates and lessons learned from an evaluation of community-wide mass drug administration for elimination of soil-transmitted helminths in the DeWorm3 trial. BMJ Open. 2021 Jul 5;11(7):e049734. doi: 10.1136/bmjopen-2021-049734.
Results Reference
derived
PubMed Identifier
33979325
Citation
Witek-McManus S, Simwanza J, Chisambi AB, Kepha S, Kamwendo Z, Mbwinja A, Samikwa L, Oswald WE, Kennedy DS, Timothy JWS, Legge H, Galagan SR, Emmanuel-Fabula M, Schaer F, Asbjornsdottir K, Halliday KE, Walson JL, Juziwelo L, Bailey RL, Kalua K, Pullan RL. Epidemiology of soil-transmitted helminths following sustained implementation of routine preventive chemotherapy: Demographics and baseline results of a cluster randomised trial in southern Malawi. PLoS Negl Trop Dis. 2021 May 12;15(5):e0009292. doi: 10.1371/journal.pntd.0009292. eCollection 2021 May.
Results Reference
derived
PubMed Identifier
33930024
Citation
Ajjampur SSR, Kaliappan SP, Halliday KE, Palanisamy G, Farzana J, Manuel M, Abraham D, Laxmanan S, Aruldas K, Rose A, Kennedy DS, Oswald WE, Pullan RL, Galagan SR, Asbjornsdottir K, Anderson RM, Muliyil J, Sarkar R, Kang G, Walson JL. Epidemiology of soil transmitted helminths and risk analysis of hookworm infections in the community: Results from the DeWorm3 Trial in southern India. PLoS Negl Trop Dis. 2021 Apr 30;15(4):e0009338. doi: 10.1371/journal.pntd.0009338. eCollection 2021 Apr.
Results Reference
derived
PubMed Identifier
33137100
Citation
DeWorm3 Trials Team. Baseline patterns of infection in regions of Benin, Malawi and India seeking to interrupt transmission of soil transmitted helminths (STH) in the DeWorm3 trial. PLoS Negl Trop Dis. 2020 Nov 2;14(11):e0008771. doi: 10.1371/journal.pntd.0008771. eCollection 2020 Nov.
Results Reference
derived
PubMed Identifier
29346377
Citation
Asbjornsdottir KH, Ajjampur SSR, Anderson RM, Bailey R, Gardiner I, Halliday KE, Ibikounle M, Kalua K, Kang G, Littlewood DTJ, Luty AJF, Means AR, Oswald W, Pullan RL, Sarkar R, Schar F, Szpiro A, Truscott JE, Werkman M, Yard E, Walson JL; DeWorm3 Trials Team. Assessing the feasibility of interrupting the transmission of soil-transmitted helminths through mass drug administration: The DeWorm3 cluster randomized trial protocol. PLoS Negl Trop Dis. 2018 Jan 18;12(1):e0006166. doi: 10.1371/journal.pntd.0006166. eCollection 2018 Jan. Erratum In: PLoS Negl Trop Dis. 2018 Jan 31;12 (1):e0006253.
Results Reference
derived
Links:
URL
http://deworm3.org
Description
University of Washington DeWorm3 Website

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

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