T among participants living in Peru (46.0 ), Brazil (37.8 ), and Ecuador (37.3 ), with lower prevalence among participants living in Thailand (6.4 ), South Africa (17.6 ), and the United States (27.1 ; P,0.001). Randomization group was not associated with HSV-2 prevalence at baseline (P = 0.44). In multivariable analysis, all factors remained significantly associated with HSV-2 prevalence with the
N of cRAI in the past three months being reported more frequently in the placebo arm (P = 0.01). Of the 1,383 participants who tested seronegative for HSV-2 at baseline, 36 (2.6 ) did not contribute person-time to incidence analyses because they were retrospectively found to be HIVinfected at baseline, tested seropositive for HSV-2 at the enrollment visit subsequent to screening, or were lost to f
N of cRAI in the past three months being reported more frequently in the placebo arm (P = 0.01). Of the 1,383 participants who tested seronegative for HSV-2 at baseline, 36 (2.6 ) did not contribute person-time to incidence analyses because they were retrospectively found to be HIVinfected at baseline, tested seropositive for HSV-2 at the enrollment visit subsequent to screening, or were lost to f
T among participants living in Peru (46.0 ), Brazil (37.8 ), and Ecuador (37.3 ), with lower prevalence among participants living in Thailand (6.4 ), South Africa (17.6 ), and the United States (27.1 ; P,0.001). Randomization group was not associated with HSV-2 prevalence at baseline (P = 0.44). In multivariable analysis, all factors remained significantly associated with HSV-2 prevalence with the
D ,25 years (7.1 per 100 person-years) and the lowest rate among participants aged 40 years (1.6 per 100 person-years; P trend = 0.001). Country of residence was also associated with HSV-2 incidence, with theDaily Oral FTC/TDF PrEP and HSV-2 among MSMthere were 72 ulcer AEs classified as Grade 2 or above, with 43 participants (4.3 ) having 1 ulcer AE. Among the 72 ulcer AEs, 23 (31.9 ) were conf
Nversion to determine whether there were differences in ulcer occurrence by randomization group in the absence of study drug. All analyses were conducted in SAS 9.3 or Stata 12.Results Study participantsCharacteristics of the 2,499 iPrEx participants have been described previously. [13] Briefly, all participants were born male and 313 (13.0 ) identified as transgender or as women. The mean age at
Lcer was identified, and 5.6 had 1 STI examination during which a groin ulcer was identified after HIV seroconversion, and thus after stopping study drug. The proportions with each type of ulcer did not differ between participants in the FTC/TDF arm and participants in the placebo arm. Finally, the iPrEx protocol did not use the HSV-2 test manufacturer's suggested cutoffs for indeterminate (IR
D ,25 years (7.1 per 100 person-years) and the lowest rate among participants aged 40 years (1.6 per 100 person-years; P trend = 0.001). Country of residence was also associated with HSV-2 incidence, with theDaily Oral FTC/TDF PrEP and HSV-2 among MSMthere were 72 ulcer AEs classified as Grade 2 or above, with 43 participants (4.3 ) having 1 ulcer AE. Among the 72 ulcer AEs, 23 (31.9 ) were conf