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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Sharon Achilles, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01873170
First received: June 5, 2013
Last updated: August 28, 2013
Last verified: August 2013

June 5, 2013
August 28, 2013
August 2013
June 2016   (final data collection date for primary outcome measure)
Quantification and characterization of immune cell populations and HIV-tropic receptor expression [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01873170 on ClinicalTrials.gov Archive Site
Assessing changes in the vaginal microflora within the first 6 months of contraceptive use [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
To describe the microflora of the upper and lower genital tracts of healthy asymptomatic women before and after 3 and 6 months of typical contraceptive use and to assess changes in the vaginal ecology within the first 6 months of contraceptive use.
Same as current
  • Reproductive tract Microenvironment [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    To assess if changes in the upper and lower genital tract microflora are correlated with alterations in immune cell populations
  • Exploratory Objective: innate factors and innate anti-HIV activity [ Time Frame: baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    To compare alterations in innate factors and innate anti-HIV activity after 3 and 6 months of contraceptive use compared with baseline.
Same as current
 
Quantification of Immune Cells in Women Using Contraception (CHIC II)
Quantification of Immune Cells in Women Using Contraception

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, plasma archive, vaginal swabs, serum

Non-Probability Sample

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

  • HIV
  • Immune Cells (Mucosal and Systemic)
  • Contraception
  • Drug: levonorgestrel exposure
    Other Names:
    • LNG-IUD (Mirena)
    • LNG/EE oral contraceptive pills (Levora)
  • Drug: DMPA exposure
    Other Name: DMPA (Depo-Provera 150mg IM)
  • Drug: etonogestrel exposure
    Other Name: ENG-implant (Nexplanon or Implanon)
  • Device: IUD insertion
    Other Names:
    • LNG-IUD (Mirena)
    • Copper T-380A IUD (ParaGard)
  • Device: subdermal contraceptive implant insertion
    Other Name: ENG-implant (Nexplanon or Implanon)
  • Combined Oral Contraceptive pills
    Levonorgestrel/ethinyl estradiol 0.15mg/30mcg daily oral tabs x21 then 7 inert tabs
    Intervention: Drug: levonorgestrel exposure
  • depot medroxyprogesterone acetate
    150mg DMPA intramuscular injection once every 3 months
    Intervention: Drug: DMPA exposure
  • Levonorgestrel-intrauterine device
    52mg levonorgestrel intrauterine device
    Interventions:
    • Drug: levonorgestrel exposure
    • Device: IUD insertion
  • Copper intrauterine device
    Copper T380A intrauterine device
    Intervention: Device: IUD insertion
  • Etonogestrel contraceptive implant
    68mg etonogestrel subdermal implant
    Interventions:
    • Drug: etonogestrel exposure
    • Device: subdermal contraceptive implant insertion
  • Control
    Low risk of pregnancy due to sterilization, heterosexual abstinence, or consistent condom use
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
275
June 2017
June 2016   (final data collection date for primary outcome measure)

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
Female
18 Years to 34 Years
Yes
Contact: Melissa Gilmore, MPH 412-641-5187 gilmoremn@upmc.edu
Contact: Sabrina Malik, MPH 412-641-8247 maliks2@upmc.edu
United States
 
NCT01873170
PRO11120183
Yes
Sharon Achilles, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Sharon Achilles, MD, PhD University of Pittsburgh
University of Pittsburgh
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP