Study design and baseline results of an open-label cluster randomized community-intervention trial to assess the effectiveness of a modified mass deworming program in reducing hookworm infection in a tribal population in southern India
Author(s)
Type
Journal Article
Abstract
Introduction: Hookworm infection is a leading cause of iron deficiency anemia and malnutrition in
resource-poor settings. Periodic mass deworming with anthelminthic drugs remains the cornerstone of
hookworm control efforts worldwide. Reinfection following treatment occurs, reflecting the human
host's inability to acquire immunity following exposure to an untreated reservoir of infection. This
cluster randomized trial will evaluate the effectiveness of a modified, population-based, mass
deworming strategy in reducing hookworm infection in an endemic southern Indian population.
Methods: Forty five tribal villages were randomized into three groups: one received annual treatment;
the second received two rounds of treatment at 1-month intervals; and the third received four rounds of
treatment e two rounds 1 month apart at the beginning, followed by another two after 6 months. Stool
samples collected through cross-sectional parasitological surveys pre- and post-intervention, and at 3-
monthly intervals for a period of 1 year were tested for presence of hookworm ova. Long-term effectiveness
of treatment will be assessed through another survey conducted 2 years after the last treatment
cycle.
Results: From a population of 11,857 individuals, 8681 (73.2%) were found to be eligible and consented to
participate, out-migration being the primary reason for non-participation. Baseline stool samples were
obtained from 2082 participants, with 18.5% having hookworm infection, although majority were low
intensity infections (<2000 eggs per gram of feces).
Discussion: This study will help identify the optimal mass deworming strategy that can achieve the
greatest impact in the shortest period of time, particularly in settings where long-term program sustainability
is a challenge
resource-poor settings. Periodic mass deworming with anthelminthic drugs remains the cornerstone of
hookworm control efforts worldwide. Reinfection following treatment occurs, reflecting the human
host's inability to acquire immunity following exposure to an untreated reservoir of infection. This
cluster randomized trial will evaluate the effectiveness of a modified, population-based, mass
deworming strategy in reducing hookworm infection in an endemic southern Indian population.
Methods: Forty five tribal villages were randomized into three groups: one received annual treatment;
the second received two rounds of treatment at 1-month intervals; and the third received four rounds of
treatment e two rounds 1 month apart at the beginning, followed by another two after 6 months. Stool
samples collected through cross-sectional parasitological surveys pre- and post-intervention, and at 3-
monthly intervals for a period of 1 year were tested for presence of hookworm ova. Long-term effectiveness
of treatment will be assessed through another survey conducted 2 years after the last treatment
cycle.
Results: From a population of 11,857 individuals, 8681 (73.2%) were found to be eligible and consented to
participate, out-migration being the primary reason for non-participation. Baseline stool samples were
obtained from 2082 participants, with 18.5% having hookworm infection, although majority were low
intensity infections (<2000 eggs per gram of feces).
Discussion: This study will help identify the optimal mass deworming strategy that can achieve the
greatest impact in the shortest period of time, particularly in settings where long-term program sustainability
is a challenge
Date Issued
2016-12-10
Date Acceptance
2016-12-03
Citation
Contemporary Clinical Trials Communications, 2016, 5, pp.49-55
ISSN
2451-8654
Publisher
Elsevier
Start Page
49
End Page
55
Journal / Book Title
Contemporary Clinical Trials Communications
Volume
5
Copyright Statement
© 2016 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license
(http://creativecommons.org/licenses/by/4.0/).
(http://creativecommons.org/licenses/by/4.0/).
License URL
Sponsor
Medical Research Council (MRC)
Grant Number
MR/K010174/1B
Subjects
Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Hookworm
Mass deworming
Cluster randomized trial
Mathematical modeling
India
SOIL-TRANSMITTED HELMINTH
NEGLECTED TROPICAL DISEASES
MATHEMATICAL-MODELS
SCHOOL-CHILDREN
CHEMOTHERAPY
REINFECTION
PREVALENCE
ELIMINATION
EFFICACY
PREDISPOSITION
Publication Status
Published