Risk of female-to-male HIV-1 transmission among men whose HIV-1–infected female partners had BV and intermediate vaginal flora in comparison to men whose HIV-1–infected female partners had normal vaginal flora.

a<p>Multivariable Cox proportional hazards analysis (adjusted hazard ratio [AHR]), adjusting for the following: Fixed covariates: age, geographic region (southern Africa versus Eastern Africa), HSV-2 status of male partner at study enrollment, male circumcision, randomization treatment assignment, and both female and male sexual transmitted disease at study enrollment (laboratory confirmed gonorrhea, chlamydia, and trichomonas); Time-dependent covariates (per quarterly visit): pregnancy (current visit), hormonal contraception (current visit), plasma HIV-1 viral load of female partner (from enrollment and month 3, 6, 12, and study exit), unprotected sex act with study partner (current visit) (based on reporting from male partner), CD4 count of female partner (6 monthly), outside partners (current visit, based on reporting from male partner), number of sex acts with their study partner (current visit), and genital ulcer disease (current visit) (based on physical exam from both partners).