Effects of Copper versus levonorgestrel intrauterine devices on mucosal microbiota and barrier function: a randomized trial among young African women

INTERVENTION: copper T intrauterine device Levonorgestrel intrauterine system CONDITION: ; Urological and Genital Diseases Urological and Genital Diseases PRIMARY OUTCOME: 12‐month median Shannon diversity of vaginal microbiota compared between arms in women randomized to Cu‐IUD vs. LNG‐IUS SECONDARY OUTCOME: Incidence of human papilloma virus (HPV), defined as a composite measure of high risk HPV, as well as individual high risk HPV types An individual with a negative test followed by two subsequent visits with a positive result for the same HPV type would be indicated as having ; incidence infection for that type. Requiring two visits with positive results will distinguish incident infections from those that are transient ; • Incidence of Neisseria gonorrhoeae (Ng) ; • Incidence of Chlamydia trachomatis (Ct) ; • Incidence of Trichomonas vaginalis (Tv) ; • 12‐month relative abundance of host epithelial integrity factors (including tight junction proteins ZO1 and 2, INVO, SPR1A, SPR1B, SPRR3, SPINK5, CRNN, DSG1, DSG3, CSTA, CATL, keratins), and immune factors and inflammatory mediators and factors involved in tissue remodeling that compromises epithelial barrier integrity (e.g. MMP8, MMP9, ELANE, LYSC, AZU1, LCP1, TLN1, CORO1A, ITGB2, FLNA, MYH9) INCLUSION CRITERIA: Willing and able to provide written informed consent for screening and trial participation • Desire and willingness to use either IUD or IUS for contraception for at least one year • Clear understanding of study randomization and commitment to use the assigned IUD • Between 18 and 40 years of age (inclusive) • Willing and able to actively participate in the study for 12 months • Willing to be tested for HIV • Sexually active • HIV‐negative • Would benefit from STI prevention