MTN-035 study schema.
VAGINA
After an approximately 7-day washout period following study product use periods, participants returned to the clinic to complete Visits 4 and 6. At these visits, participants completed study procedures, including pharyngeal, urine, blood, pelvic (individuals with a vagina or neovagina), and anorectal tests, if indicated. Additionally, participants self-administered one dose of the product they were dispensed and collected the remaining product in their sequence to use for the next four weeks during periods 2 and 3; they were also given product use instructions.Visit 8 served as the follow-up safety contact and termination visit where participants completed study procedures as well as received clinical results or treatment for UTIs/RTIs/STIs or other findings. Participant reimbursement was based on local guidelines and approved by the local IRBs/ECs prior to study implementation.We undertook several efforts to minimize the impact of the COVID-19 pandemic during our data collection period, including revising when and how products were dispensed during periods of COVID-19 restrictions. Of the 78 enrolled participants when the COVID-19 pandemic began, only four did not receive all three products (see Jacobson et al. [