Prevalence reproductive tract infections (RTI) in women targeted for microbicide trials: the Microbicide Safety Biomarkers Study in Kenya, Rwanda, and South Africa

Background: The ideal microbicide should reduce the risk of HIV-infection while preserving the integrity of the cervicovaginal epithelium. RTI could hamper the protective effect of microbicides. Methods: The Microbicide Safety Biomarkers Study is a prospective cohort study in Kenya (adult, adolescent and pregnant women), South-Africa (adult, adolescent, pregnant and women engaging in vaginal practices) and Rwanda (high-risk and HIV-positive women). Biomarkers of the cervico-vaginal microbiome and inflammation, HIV target cells and reproductive tract infections (RTI) were studied. RTI data at screening are presented. Results: There was a significant difference (p=<0.001) in the prevalence of Candida albicans, Chlamydia trachomatis (CT), Neisseria gonorrhoea (NG), syphilis and herpes simplex-2 (HSV-2) between different study groups. Pregnant women have the highest prevalence of Candida (56.7% South-Africa, 23.3% Kenya), followed by the South-African adolescents (36.7%) and vaginal practices group (32.3%). HIV-positive women in Rwanda have the highest prevalence of NG (13.3%), syphilis (20%) and HSV-2 (82.2%), and women engaging in vaginal practices have the highest prevalence of CT (25.8%). When stratifying according to sexual risk taking, no significant difference was seen for Candida or Trichomonas vaginalis (TV). But NG, syphilis and HSV-2 were associated with sexual risk taking (p=<0.001); for example HSV-2 was detected almost twice as frequent in the high risk-takers (51.5%) compared to the low risk-takers (28.6%). Further, CT was associated (p=