Table 1.

Key features of the RISE trial

Primary objective	To determine if ivermectin-based MDA with one dose is non-inferior to two-doses in reducing prevalence of scabies at 12 months
Secondary objectives	Impact of one versus two dose ivermectin-based MDA on: Population prevalence of scabies at 24 months Population prevalence of impetigo at 12 and 24 months Number of presentations to health clinics with scabies and impetigo Number of adverse events measured by passive surveillance in the 12-month period following MDA
Design	Prospective, open-label comparison using a cluster-randomised design
Sample size	20 villages (approximately 5000 participants), randomised in a 1:1 ratio to each intervention group
Intervention	Group 1: one dose of ivermectin-based MDA Group 2: two doses of ivermectin-based MDA given 7 to 14 days apart
Study setting	Western Province, Solomon Islands (scabies prevalence approximately 20%)
Inclusion criteria	All residents in the study villages
Exclusion criteria	Participants who meet exclusion criteria will not receive treatment but will still be eligible to enrol in the study and undergo skin examination Exclusion criteria are: allergy to ivermectin or permethrin; treatment within the last 7 days with ivermectin or permethrin; participant declines treatment If ivermectin is contraindicated, topical permethrin will be offered. Contraindications for ivermectin include: pregnancy; breastfeeding an infant less than 7 days old; age less than 2 years; height less than 90 cm; concurrent medication that may interact with ivermectin (for example, warfarin); or severe, acute or chronic illness on the day of MDA
Outcome measures	Presence of scabies and impetigo measured by clinical examination Conducted by trained nurses and assessed using the 2020 International Alliance for the Control of Scabies criteria Assessments will be conducted at baseline, 12 and 24 months

MDA, mass drug administration; RISE, Regimens of Ivermectin for Scabies Elimination.