Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women

Through this protocol, the investigators will recruit and follow a novel cohort of young women in the Thika, Kenya area. Enrolled women (approximately 120 aged 18-40 years who may benefit from STI prevention) will be randomized to use either Cu-IUD or LNG IUS and followed for 1 year. Through periodic genital sampling and metagenomic sequencing of vaginal wall swabs, the study will definitively determine whether Cu-IUD use (relative to levonorgestrel-containing hormonal IUD use) results in greater vaginal microbial diversity after 1 year. In addition, the study will conduct periodic testing for human papilloma virus (HPV), Chlamydia trachomatis (Ct), Neisseria gonorrhea (Ng), and Trichomonas vaginalis (Tv) to determine whether Cu-IUD users experience greater incidence of high-risk HPV or curable STIs. Finally, the study will conduct proteomic analyses to determine whether Cu-IUD users experience reduced integrity in genital mucosal barriers.

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

Exclusion criteria

• Living with HIV or HIV screening results that are not definitively negative
• Currently pregnant or planning to become pregnant within the next 12 months
• Documented or known history of infertility or sterilization
• Prior history of ectopic pregnancy
• Use of contraceptive implant, IUD or injectable progestin in the past 3 months
• Use of oral contraceptives in the past 30 days
• Planning to use alternative contraception except condoms for the trial duration
• 0-6 weeks postpartum
• Has had a hysterectomy or sterilization
• History of challenges using and IUD/IUS, including frequent expulsion
• Medical contraindications (Category 3 or 4 criteria as detailed in the WHO MEC1 to copper IUDs or LNG-IUS, including:

• Endometrial, ovarian, or cervical cancer
• Unexplained vaginal bleeding between menstrual periods or bleeding after intercourse
• History of pelvic tuberculosis
• Anatomical abnormality of the uterus incompatible with IUD insertion
• A recent septic abortion
• Untreated mucopurulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhoea or chlamydia
• Has any condition (social or medical), which in the opinion of the investigator, would make study participation unsafe or complicate data interpretation