Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

摘要

Participant flow through the study from recruitment to study endpoint. 1been together ≥8 weeks, indicated/confirmed on phone that RSP likely to participate; 2refer to eligibility criteria; 3protocol violation means not in modified intention-to-treat (mITT) primary analysis or per protocol analysis; 4eligible for mITT and per protocol analyses if week 4 and/or 12 provided but with missing data, not eligible for safety analysis; 5if female participant does not attend clinic visits but does return a swab, eligible for secondary endpoints; 6if female attends at week 4 but not week 12, still be eligible for mITT; if no visits but returns a swab, eligible for secondary endpoints; if no visits or swabs, protocol violation. Abbreviations: LTFU, Loss to follow up; W, withdrawn