Screening, enrollment and retention
genital/reproductive tract infections
SEXUALLY TRANSMITTED INFECTIONS, URINARY TRACT INFECTIONS
Prior to enrolling in the study, participants were screened for their eligibility. All participants who were enrolled provided written informed consent. Within the 45-day screening window, participants returned to the clinic for a series of administrative, behavioral, clinical, and laboratory procedures. If clinically necessary, clinical results or treatments for urinary tract infections, genital/reproductive tract infections, sexually transmitted infections, or other findings were provided at each visit. Condoms and lubricant were dispensed to participants during all clinic visits, and they also received HIV/STI risk reduction counseling at screening, enrollment, and during study visits. Consented and enrolled participants were then randomized into one of six sequences, each varying the order in which participants used the study placebo products, with a 1-week wash-out period between each 4-week product use period [Randomization sequence  order of MTN-035 studyEach participant was monitored for approximately 3.5 months and was required to attend a total of eight visits, which included the Screening and Enrollment visits. A visit was considered to be missed if the participant did not complete any portion of it within the designated visit window. However, if an interim visit was conducted to compensate for the missed regular visit, then the missed regular visit was counted as completed [