HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC
Overview
- Phase
- Not Applicable
- Intervention
- DMPA
- Conditions
- Contraception
- Sponsor
- University of Pittsburgh
- Enrollment
- 451
- Locations
- 1
- Primary Endpoint
- Genital tract CD4 cells (number and % expressing CCR5)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is being done to understand if using birth control causes changes in the immune cells within the reproductive tract 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: Depo-Provera (DMPA), NET-EN, MPA/E2 (Cyclofem®), the levonorgestrel subdermal implant (Jadelle® ), the etonogestrel subdermal implant (Implanon® or Nexplanon® ) and the copper IUD.
Investigators
Sharon Achilles
Principal Investigator and Protocol Chair
University of Pittsburgh
Eligibility Criteria
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)
- •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
- •HIV-uninfected based on testing performed by study staff at screening
- •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 or NET-EN 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, trichomoniasis, and symptomatic BV; or cervical infection, including N. gonorrhoeae, Chlamydia 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. Women who have had diagnosed genital infections should have completed treatment at least 30 days before the time of enrollment.
- •Any history of immunosuppression (includes diabetes, HIV infection, and chronic steroid use)
- •Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment
Arms & Interventions
DMPA
Depot medroxyprogesterone acetate
Intervention: DMPA
NET-EN
Norethisterone enantate
Intervention: NET-EN
MPA/E2
Medroxyprogesterone acetate and estradiol cypionate
Intervention: MPA/E2
LNG-I
Levonorgestrel subdermal implant
Intervention: LNG-I
ENG-I
Etonogestrel subdermal implant
Intervention: ENG-I
Cu-IUD
Copper IUD
Intervention: Cu-IUD
Outcomes
Primary Outcomes
Genital tract CD4 cells (number and % expressing CCR5)
Time Frame: Change from baseline at 3 months
To quantify and characterize immune cell populations and HIV-tropic receptor expression in the genital tract and blood at baseline and after 1, 3 and 6 months of typical contraceptive use. Immune cell populations will be quantified and characterized using flow cytometry.
Secondary Outcomes
- Vaginal microbiota (key microbes)(Change from baseline at 3 months)
- Serum hemoglobin(Change from baseline at 6 months)
- Serum concentration of estradiol and progesterone/progestin(Change from baseline at 3 months)