Special considerations during the COVID-19 pandemic
This trial has enrolled participants during the COVID-19 pandemic with enrollment suspended from March 13, 2020, through August 24, 2020, and from December 2, 2020, through January 29, 2021. Furthermore, during the COVID-19 pandemic, linkage-to-care and some healthcare visits transitioned to remote participant interactions. In an effort to incorporate the effect of delayed linkage-to-care and treatment initiation during the COVID-19 pandemic, we extended the time frame for which longitudinal outcomes will be collected from 12 months to up to 18 months, also modifying treatment initiation to within 18 months of enrollment.