Quantification of Immune Cells in Women Using Contraception (CHIC II) (NCT01873170) | Clinical Trial Compass
CompletedNot Applicable
Quantification of Immune Cells in Women Using Contraception (CHIC II)
United States326 participantsStarted 2013-08
Plain-language summary
This study is being done to understand if using birth control causes changes in the immune cells within the reproductive tract (including the cervix and the lining of the uterus) of healthy women. Immune cells are important because they help prevent infections from starting and help fight infections that have started. Immune cells are also the type of cells that HIV (human immunodeficiency virus) infects so understanding more about them will help to better understand how to prevent the spread of HIV.
Immune cells will be studied from the reproductive tract of women who want to start using one of the following contraceptives: an oral contraceptive pill (COC), Depo-Provera (DMPA), the levonorgestrel IUD (Mirena®), the copper IUD (ParaGard®), or the etonogestrel subdermal implant (Nexplanon®).Immune cells will also be studied from the reproductive tract of women who are not using birth control and who are not at risk of pregnancy for comparison.
Who can participate
Age range
18 Years – 34 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 through 34 years (inclusive) at screening
. Non-pregnant women in general good health as determined by the site clinician
. 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)
. 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
. 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
. Able and willing to provide adequate locator information
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification and characterization of immune cell populations and HIV-tropic receptor expression
. HIV-uninfected based on testing performed by study staff at screening (per HIV testing algorithm in Appendices I)
. 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
. Use of any hormonal or intrauterine contraceptive method within 30 days of enrollment
. Use of DMPA within 10 months of enrollment
. Pregnancy or breastfeeding within 60 days of enrollment
. 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)
. 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
. New sexual partner within 90 days of enrollment
. 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
. Any history of immunosuppression (includes diabetes, HIV infection, and chronic steroid use)