Study procedures
For pericoital rectal administration, each participant was provided with placebo inserts, placebo suppositories, and placebo (water) douche bottles (see Fig. MTN-035 Placebo Study ProductsThe schedule of participants' study activities can be seen in Fig. MTN-035 Study SchemaAfter an approximately 7-day wash-out period following study product use periods, participants returned to the clinic to complete Visits 4 and 6 [Visit 8 served as the follow-up safety contact and termination visit, during which participants underwent study procedures and received clinical results or treatment for UTIs/RTIs/STIs or other relevant findings [To minimize the impact of the COVID-19 pandemic during the data collection period, several measures were implemented, including adjustments to the dispensing of products based on COVID-19 restrictions (i.e., dispensing more than one product at a time) [