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

NCT01873170 | Completed DMC

• 1 other identifier: STUDY19100126
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Immune Cells (Mucosal and Systemic); Contraception

Keywords

immune cells; contraception; intrauterine device; IUD; copper; microflora; DMPA; etonogestrel; subdermal implant

Outcome Measures

Primary Outcomes (1)

• Quantification and characterization of immune cell populations and HIV-tropic receptor expression

  To quantify and characterize immune cell populations and HIV-tropic receptor expression in the upper and lower genital tract and blood at baseline and after 3 and 6 months of typical contraceptive use

  up to 6 months

Secondary Outcomes (1)

• Assessing changes in the vaginal microflora within the first 6 months of contraceptive use

  baseline, 3 months, 6 months

Other Outcomes (1)

• Reproductive tract Microenvironment

  baseline, 3 months, 6 months

Study Arms (6)

Combined Oral Contraceptive pills

Levonorgestrel/ethinyl estradiol 0.15mg/30mcg daily oral tabs x21 then 7 inert tabs

Drug: levonorgestrel exposure

depot medroxyprogesterone acetate

150mg DMPA intramuscular injection once every 3 months

Drug: DMPA exposure

Levonorgestrel-intrauterine device

52mg levonorgestrel intrauterine device

Drug: levonorgestrel exposure; Device: IUD insertion

Copper intrauterine device

Copper T380A intrauterine device

Device: IUD insertion

Etonogestrel contraceptive implant

68mg etonogestrel subdermal implant

Drug: etonogestrel exposure; Device: subdermal contraceptive implant insertion

Control

Low risk of pregnancy due to sterilization, heterosexual abstinence, or consistent condom use

Interventions

levonorgestrel exposure DRUG

Also known as: LNG-IUD (Mirena), LNG/EE oral contraceptive pills (Levora)

Combined Oral Contraceptive pills; Levonorgestrel-intrauterine device

DMPA exposure DRUG

Also known as: DMPA (Depo-Provera 150mg IM)

depot medroxyprogesterone acetate

etonogestrel exposure DRUG

Also known as: ENG-implant (Nexplanon or Implanon)

Etonogestrel contraceptive implant

IUD insertion DEVICE

Also known as: LNG-IUD (Mirena), Copper T-380A IUD (ParaGard)

Copper intrauterine device; Levonorgestrel-intrauterine device

subdermal contraceptive implant insertion DEVICE

Also known as: ENG-implant (Nexplanon or Implanon)

Etonogestrel contraceptive implant

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy women, age 18-34 years, who are HIV negative and non-pregnant.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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 36 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Center for Family Planning Research

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma archive, vaginal swabs, serum

MeSH Terms

Interventions

Levonorgestrel; Ethinyl Estradiol-Norgestrel Combination; N,N-dimethyl-4-anisidine; Medroxyprogesterone Acetate; etonogestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethinyl Estradiol; Norpregnatrienes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes

Study Officials

• Beatrice Chen, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 7, 2013
• Study Start: August 1, 2013
• Primary Completion: February 20, 2017
• Study Completion: October 1, 2020
• Last Updated: December 27, 2021

Record last verified: 2021-12

Locations

US (1)