Urological and Genital Diseases
Conditions
Sponsors
Seattle Childrens Research Institute
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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: o Endometrial, ovarian, or cervical cancer o Unexplained vaginal bleeding between menstrual periods or bleeding after intercourse o History of pelvic tuberculosis o Anatomical abnormality of the uterus incompatible with IUD insertion o A recent septic abortion o 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month median Shannon diversity of vaginal microbiota compared between arms in women randomized to Cu-IUD vs. LNG-IUS | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Kenya
Contacts
Public ContactEddah Mbugua
Study Physician
Outcome results
None listed