Quantification of Immune Cells in Women Using Contraception (CHIC II)

Inclusion Criteria:

1. Age 18 through 34 years (inclusive) at screening

2. Non-pregnant women in general good health as determined by the site clinician

3. Premenopausal with history of regular menstrual cycles (regular cycles defined as
occurring every 21-35 days when not using hormones and with a variation of typical
cycle length of no more than 5 days)

4. Women enrolling into the control group only: Regular and consistent condom use, prior
surgical sterilization by participant or sexual partner, or heterosexually abstinent
for entire study participation

5. Able and willing to provide written informed consent to be screened for and to take
part in the study. Including willingness to undergo all study-related assessments and
follow all study-related procedures

6. Able and willing to provide adequate locator information

7. HIV-uninfected based on testing performed by study staff at screening (per HIV testing
algorithm in Appendices I)

8. At screening and enrollment, agrees not to participate in other research studies
involving drugs, medical devices, or vaginal products while enrolled in this trial

Exclusion Criteria:

1. Use of any hormonal or intrauterine contraceptive method within 30 days of enrollment

2. Use of DMPA within 10 months of enrollment

3. Pregnancy or breastfeeding within 60 days of enrollment

4. Surgical procedure involving the pelvis in the 30 days prior to enrollment (includes
dilation and curettage, cryosurgery and biopsy of the vagina, vulva, cervix, and
endometrium)

5. Internal vaginal use of any device (includes sex toys, cervical caps, diaphragms,
menstrual collection devices, and pessaries; excludes tampons and condoms) or product
(includes N9, microbicide, douche, antifungal, steroid, or hormone) in the 30 days
prior to enrollment

6. New sexual partner within 90 days of enrollment

7. Urogenital infection or suspected infection within 30 days of enrollment including:
symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis;
or cervical infection, including N. gonorrhea, C. trachomatis, or mucopurulent
cervicitis; syphilis; HSV lesions, or other sores (Note: seropositive HSV without
active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract
infection; recent exposure to a partner with GC, CT, Trichomonas, syphilis, or NGU

8. Any history of immunosuppression (includes diabetes, HIV infection, and chronic
steroid use)

9. Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment

10. Menses or other vaginal bleeding at the time of Enrollment* (*Women who have vaginal
bleeding at the scheduled Enrollment Visit may return at a different date to be
re-examined and possibly enrolled provided they are still within the 90-day screening
window and meet all criteria).

11. Vaginal or anal intercourse within 36 hours prior to enrollment

12. Heterosexual intercourse since last menses that places the participant at risk of
pregnancy (without condom use or sterilization of at least one partner)

13. History of hysterectomy

14. History of malignancy within the pelvis (includes uterus, cervix, vagina, and vulva)

15. Contraindication, allergy or intolerance to use of the contraceptive desired by the
participant

16. Any condition that, in the opinion of the Investigator, would preclude provision of
consent, make participation in the study unsafe, complicate interpretation of study
outcome data, or otherwise interfere with achieving the study objectives