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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

Title: 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
Authors: Sarkar, R
Rose, A
Mohan, VR
Ajjampur, SSR
Veluswamy, V
Srinivasan, R
Muliyil, J
Rajshekhar, V
George, K
Balraj, V
Grassly, NC
Anderson, RM
Brooker, SJ
Kang, G
Item 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
Issue Date: 10-Dec-2016
Date of Acceptance: 3-Dec-2016
URI: http://hdl.handle.net/10044/1/54561
DOI: https://dx.doi.org/10.1016/j.conctc.2016.12.002
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/).
Sponsor/Funder: Medical Research Council (MRC)
Funder's Grant Number: MR/K010174/1B
Keywords: 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
Appears in Collections:Faculty of Medicine
Epidemiology, Public Health and Primary Care



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