Used acyclovir or valacyclovir during study follow-up.HSV-2 prevalenceOf the 2,499 participants, 1383 (55.3 ) tested negative for HSV-2 at baseline, 892 (35.7 ) tested positive, 223 (8.9 ) had indeterminate tests, and one test was not done. Of the 223 with indeterminate tests at baseline, 114 (51.1 ) tested positive for HSV-2 infection at some point during follow-up. Factors associated with testin
Used acyclovir or valacyclovir during study follow-up.HSV-2 prevalenceOf the 2,499 participants, 1383 (55.3 ) tested negative for HSV-2 at baseline, 892 (35.7 ) tested positive, 223 (8.9 ) had indeterminate tests, and one test was not done. Of the 223 with indeterminate tests at baseline, 114 (51.1 ) tested positive for HSV-2 infection at some point during follow-up. Factors associated with testin
O predict the probability of having detectable drug and the probability that the level of tenofovir diphosphate (TFV-DP) in PBMCs was .16 fmol per million viable cells, the concentration associated with an estimated 90 reduction in HIV acquisition. [15] Drug levels were multiply imputed [16] for visits at which drug level testing was not conducted but the participant was still taking study drug,
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
No differences by randomization group in the proportion of participants with 1 STI examination during which a perianal ulcer (FTC/TDF 3.5 vs. placebo 4.7 , P = 0.37) or groin ulcer (FTC/TDF 2.5 vs. placebo 1.9 , P = 0.51) was identified; results were similar after excluding participants with a positive syphilis rapid plasma reagin test at the same visit. However, symptoms that prompted STI exam
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
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
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