Introduction Evidence suggests that women with bacterial vaginosis (BV) are at increased risk for infection with high risk sub-types of human papilloma virus (hrHPV). Among women participating in a randomised trial of periodic presumptive treatment (PPT) to reduce vaginal infections including BV, we previously reported reductions in bacterial STIs among women receiving PPT compared to placebo. In the current analysis, we assessed the effect of PPT on acquisition of HR-HPV among Kenyan women enrolled in the trial.
Methods Nonpregnant, HIV-uninfected women aged 18–45 from Kenya and the United States were randomised to receive intravaginal metronidazole 750 mg plus miconazole 200 mg or matching placebo for 5 consecutive nights each month for 12 months. Genital specimens were collected every other month. Following completion of the trial, enrollment and follow-up specimens from participants at the three sites in Kenya were tested for hrHPV (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) using the Hologic APTIMA HPV assay. Poisson regression models were used to assess the intervention effect on hrHPV incidence and time to first detection of hrHPV.
Results Among 176 Kenyan women participating in the trial, 168/176 (95%) had specimens available for analysis (intervention n=84; placebo n=84). Baseline hrHPV prevalence was 17% (n=29) and similar by arm. Among participants without detectable hrHPV at enrollment, 26 participants had hrHPV detected during 114.6 person-years (incidence=22.7/100 person-years), with similar incidence in the intervention versus placebo arm (21.7/100 person-years versus 23.6/100 person-years; incidence rate ratio [IRR]=0.92, 95% CI 0.42, 1.99).
Conclusions This intervention, which significantly reduced BV over 12 months, did not impact acquisition of hrHPV. However, the high incidence of hrHPV provides evidence in support HPV vaccination efforts in this region.