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

December 22, 2021 updated by: Sharon Achilles, University of Pittsburgh

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Center for Family Planning Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • ENG-implant (Nexplanon or Implanon)
Device: subdermal contraceptive implant insertion
Other Names:
  • ENG-implant (Nexplanon or Implanon)
Control
Low risk of pregnancy due to sterilization, heterosexual abstinence, or consistent condom use

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quantification and characterization of immune cell populations and HIV-tropic receptor expression
Time Frame: up to 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessing changes in the vaginal microflora within the first 6 months of contraceptive use
Time Frame: baseline, 3 months, 6 months
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.
baseline, 3 months, 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reproductive tract Microenvironment
Time Frame: baseline, 3 months, 6 months
To assess if changes in the upper and lower genital tract microflora are correlated with alterations in immune cell populations
baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Beatrice Chen, MD, MPH, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY19100126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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