Approximately 35 months total. Accrual will require approximately 21 months and follow-up will continue until 217 incident HIV infections are observed in the study, which is expected to occur approximately 14 months after the end of the accrual period.
Each participant is expected to have a minimum of 12 and a maximum of 33 months of study product use. Each participant will have an additional approximate 8 weeks of follow-up off study product to identify potential delayed seroconversions due to masked infections that are not detected during the product use period.