HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 1
- 主要终点
- Genital tract CD4 cells (number and % expressing CCR5)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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).
- •Vaginal or anal intercourse within 2 days (48 hours) prior to enrollment
- •Heterosexual intercourse since last menses that places the participant at risk of pregnancy (without condom use or sterilization of at least one partner)
- •History of hysterectomy
- •History of malignancy within the pelvis (includes uterus, cervix, vagina, and vulva)
- •Contraindication, allergy or intolerance to use of the contraceptive desired by the participant
- •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
研究组 & 干预措施
DMPA
Depot medroxyprogesterone acetate
干预措施: DMPA (Drug)
NET-EN
Norethisterone enantate
干预措施: NET-EN (Drug)
MPA/E2
Medroxyprogesterone acetate and estradiol cypionate
干预措施: MPA/E2 (Drug)
LNG-I
Levonorgestrel subdermal implant
干预措施: LNG-I (Device)
ENG-I
Etonogestrel subdermal implant
干预措施: ENG-I (Device)
Cu-IUD
Copper IUD
干预措施: Cu-IUD (Device)
结局指标
主要结局
Genital tract CD4 cells (number and % expressing CCR5)
时间窗: 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.
次要结局
- 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)
研究者
Sharon Achilles
Principal Investigator and Protocol Chair
University of Pittsburgh