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Author(s): Myra Hardy 1,2, Josaia Samuela 3, Mike Kama 3, Meciusela Tuicakau 3, Lucia Romani 4, Margot J. Whitfeld 5, Christopher L. King 6, Gary J. Weil 7, Tibor Schuster [...], Background Scabies is a neglected tropical disease hyperendemic to many low- and middle-income countries. Scabies can be successfully controlled using mass drug administration (MDA) using 2 doses of ivermectin-based treatment. If effective, a strategy of 1-dose ivermectin-based MDA would have substantial advantages for implementing MDA for scabies at large scale. Methods and findings We did a cluster randomised, noninferiority, open-label, 3-group unblinded study comparing the effectiveness of control strategies on community prevalence of scabies at 12 months. All residents from 35 villages on 2 Fijian islands were eligible to participate. Villages were randomised 1:1:1 to 2-dose ivermectin-based MDA (IVM-2), 1-dose ivermectin-based MDA (IVM-1), or screen and treat with topical permethrin 5% for individuals with scabies and their household contacts (SAT). All groups also received diethylcarbamazine and albendazole for lymphatic filariasis control. For IVM-2 and IVM-1, oral ivermectin was dosed at 200 [mu]g/kg and when contraindicated substituted with permethrin. We designated a noninferiority margin of 5%. We enrolled 3,812 participants at baseline (July to November 2017) from the 35 villages with median village size of 108 (range 18 to 298). Age and sex of participants were representative of the population with 51.6% male and median age of 25 years (interquartile range 10 to 47). We enrolled 3,898 at 12 months (July to November 2018). At baseline, scabies prevalence was similar in all groups: IVM-2: 11.7% (95% confidence interval (CI) 8.5 to 16.0); IVM-1: 15.2% (95% CI 9.4 to 23.8); SAT: 13.6% (95% CI 7.9 to 22.4). At 12 months, scabies decreased substantially in all groups: IVM-2: 1.3% (95% CI 0.6 to 2.5); IVM-1: 2.7% (95% CI 1.1 to 6.5); SAT: 1.1% (95% CI 0.6 to 2.0). The risk difference in scabies prevalence at 12 months between the IVM-1 and IVM-2 groups was 1.2% (95% CI -0.2 to 2.7, p = 0.10). Limitations of the study included the method of scabies diagnosis by nonexperts, a lower baseline prevalence than anticipated, and the addition of diethylcarbamazine and albendazole to scabies treatment. Conclusions All 3 strategies substantially reduced prevalence. One-dose was noninferior to 2-dose ivermectin-based MDA, as was a screen and treat approach, for community control of scabies. Further trials comparing these approaches in varied settings are warranted to inform global scabies control strategies. Trial registration Clinitrials.gov NCT03177993 and ANZCTR N12617000738325.

Scabies and related bacterial skin and soft tissue infections (SSTIs) are highly prevalent in many tropical, low- and middle-income settings. These skin conditions contribute to higher healthcare costs and burdens on healthcare systems. The Big Skin Health Intervention Fiji Trial ("Big SHIFT") carried out surveillance for scabies and SSTIs from July 2018 to June 2019 in the Northern Division of Fiji, an area with high prevalence of scabies, prior to a division-wide ivermectin-based mass drug administration (MDA) campaign. Using data from Big SHIFT, we sought to estimate the annual direct healthcare costs of scabies and related SSTIs for the Northern Division and extrapolate these costs to the national level. We categorized SSTIs as being potentially scabies-related or unlikely scabies-related, based on a previous study. The analysis used a health system perspective, with the main resource use categories of outpatient visits, bed days during admissions, medicines, and diagnostic tests. We extrapolated the total annual number of cases and direct healthcare costs for all divisions in Fiji based upon previous scabies and impetigo prevalence data across all divisions. The average cost per PHC presentation for scabies was US$17.7, and for potentially scabies-related SSTI was $18.3. The average cost per hospital admission for a potentially scabies-related SSTI case was $439. The estimated annual healthcare costs of scabies and related SSTIs in Fiji was US$3.0 million, with cost per capita of $3.3. Scabies and related SSTIs lead to a heavy economic burden in Fiji and prevention would reduce these healthcare costs., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Akpan 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.)