PMID- 36917597 OWN - NLM STAT- MEDLINE DCOM- 20230316 LR - 20230328 IS - 1935-2735 (Electronic) IS - 1935-2727 (Print) IS - 1935-2727 (Linking) VI - 17 IP - 3 DP - 2023 Mar TI - Impact of adverse events during community-wide mass drug administration for soil-transmitted helminths on subsequent participation-a Theory of Planned Behaviour analysis. PG - e0011148 LID - 10.1371/journal.pntd.0011148 [doi] LID - e0011148 AB - BACKGROUND: Experiencing adverse events (AEs) during mass drug administration (MDA) could affect participation in future MDAs. This study aims to understand the potential influence of AEs during a community-wide MDA (cMDA) trial for soil-transmitted helminths (STH) in India on intention to participate in future cMDAs. METHODS: This study was conducted using a multi-method quantitative and qualitative approach among 74 participants who experienced an AE during STH cMDA and the 12 participants who subsequently refused cMDA treatment of the ongoing DeWorm3 trial. Path analysis and thematic analysis guided by the Theory of Planned Behaviour, was used. PRINCIPAL FINDINGS: Among 74 individuals who reported an AE, 12% refused treatment in the cMDA immediately subsequent to their AE and 4% refused in all subsequent cMDAs. Of these 74 individuals, 59 (80%) completed a survey and eight participated in in-depth interviews. A positive attitude towards deworming and perceived ability to participate in cMDA (perceived behavioural control) were significant predictors of intention to participate in cMDA (p<0.05). A positive attitude towards cMDA was associated with caste (chi2 = 3.83, P = 0.05), particularly among the scheduled caste/scheduled tribe (SC/ST) (62%). Perceived behavioural control in cMDA participation was associated with occupation (chi2 = 5.02, P<0.05), with higher perceived control among those engaged in skilled occupations (78%). Intention to participate in subsequent cMDAs was associated with caste and family type (chi2 = 3.83, P = 0.05 and chi2 = 7.50, P<0.05 respectively) and was higher among SC/ST (62%) and those with extended families (67%). In-depth interviews demonstrated that perceived severe AEs may lead to treatment refusal in future, particularly if children were affected. CONCLUSIONS: Intention to participate in future STH cMDAs was associated with caste (SC/ST) and family type (extended families). Therefore, community mobilization messages about potential AEs and their management may need to intentionally target non-SC/ST households, nuclear families, and those engaged in unskilled occupations to increase cMDA participation given the possibility of AEs occurring. TRIAL REGISTRATION: NCT03014167, ClinicalTrials.gov. CI - Copyright: (c) 2023 Aruldas et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. FAU - Aruldas, Kumudha AU - Aruldas K AD - The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India. FAU - Israel, Gideon John AU - Israel GJ AD - The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India. FAU - Johnson, Jabaselvi AU - Johnson J AD - The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India. FAU - Titus, Angelin AU - Titus A AD - The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India. FAU - Saxena, Malvika AU - Saxena M AD - The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India. FAU - Kaliappan, Saravanakumar Puthupalayam AU - Kaliappan SP AD - The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India. FAU - Ramesh, Rohan Michael AU - Ramesh RM AD - The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India. FAU - Walson, Judd L AU - Walson JL AD - Departments of Global Health, Medicine, Pediatrics and Epidemiology, University of Washington, Seattle, Washington, United States of America. AD - The DeWorm3 Project, University of Washington, Seattle, Washington, United States of America. FAU - Means, Arianna Rubin AU - Means AR AD - The DeWorm3 Project, University of Washington, Seattle, Washington, United States of America. AD - Department of Global Health, University of Washington, Seattle, Washington, United States of America. FAU - Ajjampur, Sitara S R AU - Ajjampur SSR AUID- ORCID: 0000-0003-3419-6577 AD - The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India. LA - eng SI - ClinicalTrials.gov/NCT03014167 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230314 PL - United States TA - PLoS Negl Trop Dis JT - PLoS neglected tropical diseases JID - 101291488 RN - 122665-73-0 (4-((2-chloroethyl)(2-mesyloxyethyl)amino)benzoylglutamic acid) RN - 0 (Soil) SB - IM MH - Child MH - Animals MH - Humans MH - Mass Drug Administration/methods MH - *Helminthiasis/drug therapy MH - Soil/parasitology MH - Theory of Planned Behavior MH - *Helminths PMC - PMC10013912 COIS- The authors have declared that no competing interests exist. EDAT- 2023/03/15 06:00 MHDA- 2023/03/17 06:00 PMCR- 2023/03/14 CRDT- 2023/03/14 13:34 PHST- 2022/09/07 00:00 [received] PHST- 2023/02/07 00:00 [accepted] PHST- 2023/03/14 13:34 [entrez] PHST- 2023/03/15 06:00 [pubmed] PHST- 2023/03/17 06:00 [medline] PHST- 2023/03/14 00:00 [pmc-release] AID - PNTD-D-22-01128 [pii] AID - 10.1371/journal.pntd.0011148 [doi] PST - epublish SO - PLoS Negl Trop Dis. 2023 Mar 14;17(3):e0011148. doi: 10.1371/journal.pntd.0011148. eCollection 2023 Mar.