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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
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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
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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
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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
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Nt HSV-2 infection in iPrEx was receptive anal intercourse without a condom, a finding that has been reported in several studies of behavioral risk factors for HSV-2 acquisition in MSM. [18,19,20] The rectal mucosa and cervicovaginal mucosa may differ in their susceptibility to HSV-2 infection. Additionally, although oral dosing of tenofovir achieves drug concentrations that are 20?00 times higher
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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
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Nt HSV-2 infection in iPrEx was receptive anal intercourse without a condom, a finding that has been reported in several studies of behavioral risk factors for HSV-2 acquisition in MSM. [18,19,20] The rectal mucosa and cervicovaginal mucosa may differ in their susceptibility to HSV-2 infection. Additionally, although oral dosing of tenofovir achieves drug concentrations that are 20?00 times higher
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Tive to HIV. [12] Drug concentration is also affected by adherence; while iPrExhighest rate among participants living in Ecuador (9.7 per 100 person-years) and the lowest rate among participants living in Thailand (1.7 per 100 person-years). The only behavioral factor associated with time to HSV-2 incidence was ncRAI in the past three months (HR 2.0, 95 CI: 1.4-3.0; P,0.001). In multivariable ana