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
  Purpose

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.


Condition Intervention
HIV
Immune Cells (Mucosal and Systemic)
Contraception
Drug: levonorgestrel exposure
Drug: DMPA exposure
Drug: etonogestrel exposure
Device: IUD insertion
Device: subdermal contraceptive implant insertion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantification of Immune Cells in Women Using Contraception

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

whole blood, plasma archive, vaginal swabs, serum


Estimated Enrollment: 275
Study Start Date: August 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Combined Oral Contraceptive pills
Levonorgestrel/ethinyl estradiol 0.15mg/30mcg daily oral tabs x21 then 7 inert tabs
Drug: levonorgestrel exposure
Other Names:
  • LNG-IUD (Mirena)
  • LNG/EE oral contraceptive pills (Levora)
depot medroxyprogesterone acetate
150mg DMPA intramuscular injection once every 3 months
Drug: DMPA exposure
Other Name: DMPA (Depo-Provera 150mg IM)
Levonorgestrel-intrauterine device
52mg levonorgestrel intrauterine device
Drug: levonorgestrel exposure
Other Names:
  • LNG-IUD (Mirena)
  • LNG/EE oral contraceptive pills (Levora)
Device: IUD insertion
Other Names:
  • LNG-IUD (Mirena)
  • Copper T-380A IUD (ParaGard)
Copper intrauterine device
Copper T380A intrauterine device
Device: IUD insertion
Other Names:
  • LNG-IUD (Mirena)
  • Copper T-380A IUD (ParaGard)
Etonogestrel contraceptive implant
68mg etonogestrel subdermal implant
Drug: etonogestrel exposure
Other Name: ENG-implant (Nexplanon or Implanon)
Device: subdermal contraceptive implant insertion
Other Name: ENG-implant (Nexplanon or Implanon)
Control
Low risk of pregnancy due to sterilization, heterosexual abstinence, or consistent condom use

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873170

Contacts
Contact: Melissa Gilmore, MPH 412-641-5187 gilmoremn@upmc.edu
Contact: Sabrina Malik, MPH 412-641-8247 maliks2@upmc.edu

Locations
United States, Pennsylvania
Center for Family Planning Research Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sabrina Malik, MPH    412-641-8257    maliks2@upmc.edu   
Contact: Melissa Gilmore, MPH    412-641-5187    gilmoremn@upmc.edu   
Principal Investigator: Sharon Achilles, MD, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sharon Achilles, MD, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Sharon Achilles, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01873170     History of Changes
Other Study ID Numbers: PRO11120183
Study First Received: June 5, 2013
Last Updated: August 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
immune cells
contraception
intrauterine device
IUD
copper
microflora
DMPA
etonogestrel
subdermal implant

Additional relevant MeSH terms:
Contraceptive Agents
Levonorgestrel
Medroxyprogesterone Acetate
3-keto-desogestrel
Desogestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Copper
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Trace Elements
Micronutrients
Growth Substances
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 15, 2014