Conclusions
EVENTS
In this analysis of a SWD trial that evaluates SRH among Assiniboine and Sioux youth, we aimed to understand whether the COVID-19 pandemic may have produced a secular trend affecting the trial’s primary outcome. We reported quantitative associations between self-assessed impacts of COVID on sexual behaviors and self-reported sexual behaviors, and qualitative evidence of sex continuing despite limitations posed by COVID mitigation strategies. Together, results suggest evidence of a secular trend. Results will inform both sensitivity analyses and efforts to correctly specify the secular trend at trial end. Reporting these mid-trial findings encourages transparent reporting for unexpected events that occur during the implementation of a SWD trial during a global pandemic and will be informative for other cluster randomized controlled trials implemented in community settings.