The association of HPV infection and vaginal microbiota of reproductive women in China: A multicenter cohort study protocol

Cervical cancer is a global health concern. Persistent oncogenic human papillomavirus (HPV) infection is a prerequisite for the development of cervical cancer. Emerging research indicates that the vaginal microbiota may play both protective and harmful roles in the acquisition and persistence of HPV and the development of cervical cancer. This multicenter cohort study mainly aims to reveal the association of vaginal microbiota with the outcome of HPV infection in six months in women of reproductive age. We will recruit 50 research centers and enroll a total of about 10,000 female volunteers with a series of strict inclusion and exclusion criteria across China, including HPV positive and HPV negative women. A unified questionnaire will be used to obtain the sociodemographic information, clinical data and lifestyle of all volunteers. Specimens including vaginal secretions swabs and cervical exfoliated cells will be collected at the first visit and follow-up after six months. We will use 16S rRNA sequencing to characterize the vaginal microbiota of volunteers’ vaginal swabs. Twenty-one HPV genotypes and other sexually transmitted pathogens, including Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum, Mycoplasma hominis, Mycoplasma genitalium and Herpes simplex virus type Ⅱ will be examined using flow-through hybridization and gene chip. The association of HPV infection and vaginal microbiota will be investigated, and the core microbiota attributes to the persistent HPV infection will be analyzed in this study.