HIVCHIC-IINCT01873170
Quantification of Immune Cells in Women Using Contraception (CHIC II)
An observational study of HIV and Immune Cells (Mucosal and Systemic), run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Immune Cells (Mucosal and Systemic), Contraception
- What is being tested?
- levonorgestrel exposure, DMPA exposure and etonogestrel exposure
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women, age 18-34 years, who are HIV negative and non-pregnant.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Family Planning Research
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
- Conditions
- HIV, Immune Cells (Mucosal and Systemic), Contraception
- Being tested
- levonorgestrel exposure, DMPA exposure, etonogestrel exposure, IUD insertion, subdermal contraceptive implant insertion
- Keywords
- immune cells, contraception, intrauterine device, IUD, copper, microflora, DMPA, etonogestrel, subdermal implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levonorgestrel exposureDrug
Also called LNG-IUD (Mirena), LNG/EE oral contraceptive pills (Levora)
DMPA exposureDrug
Also called DMPA (Depo-Provera 150mg IM)
etonogestrel exposureDrug
Also called ENG-implant (Nexplanon or Implanon)
IUD insertionDevice
Also called LNG-IUD (Mirena), Copper T-380A IUD (ParaGard)
subdermal contraceptive implant insertionDevice
Also called ENG-implant (Nexplanon or Implanon)
| Study group | Role | What they receive |
|---|---|---|
| Combined Oral Contraceptive pills | Levonorgestrel/ethinyl estradiol 0.15mg/30mcg daily oral tabs x21 then 7 inert tabs Receives: Drug: levonorgestrel exposure | |
| depot medroxyprogesterone acetate | 150mg DMPA intramuscular injection once every 3 months Receives: Drug: DMPA exposure | |
| Levonorgestrel-intrauterine device | 52mg levonorgestrel intrauterine device Receives: Drug: levonorgestrel exposure; Device: IUD insertion | |
| Copper intrauterine device | Copper T380A intrauterine device Receives: Device: IUD insertion | |
| Etonogestrel contraceptive implant | 68mg etonogestrel subdermal implant Receives: Drug: etonogestrel exposure; Device: subdermal contraceptive implant insertion | |
| Control | Low risk of pregnancy due to sterilization, heterosexual abstinence, or consistent condom use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 6 months
Secondary outcomes (1)
Assessing changes in the vaginal microflora within the first 6 months of contraceptive use
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.
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startAug 2013
- Primary completion20 Feb 2017
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Achilles, University of Pittsburgh
- Investigators
- Beatrice Chen, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873170
- Sponsor's protocol ID
- STUDY19100126
- Acronym
- CHIC-II
- Status last verified
- Dec 2021
- First submitted
- 5 Jun 2013
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Immune Cells in Women Using Contraception
- ClinicalTrials.gov ID
- NCT01873170
- Acronym / sponsor ID
- CHIC-II / STUDY19100126
- Conditions
- HIV, Immune Cells (Mucosal and Systemic), Contraception
- Keywords
- immune cells, contraception, intrauterine device, IUD, copper, microflora, DMPA, etonogestrel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Combined Oral Contraceptive pills | – | Drug: levonorgestrel exposureLevonorgestrel/ethinyl estradiol 0.15mg/30mcg daily oral tabs x21 then 7 inert tabs |
| depot medroxyprogesterone acetate | – | Drug: DMPA exposure150mg DMPA intramuscular injection once every 3 months |
| Levonorgestrel-intrauterine device | – | Drug: levonorgestrel exposure, Device: IUD insertion52mg levonorgestrel intrauterine device |
| Copper intrauterine device | – | Device: IUD insertionCopper T380A intrauterine device |
| Etonogestrel contraceptive implant | – | Drug: etonogestrel exposure, Device: subdermal contraceptive implant insertion68mg etonogestrel subdermal implant |
| Control | – | –Low risk of pregnancy due to sterilization, heterosexual abstinence, or consistent condom use |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women, age 18-34 years, who are HIV negative and non-pregnant.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levonorgestrel exposureAlso: LNG-IUD (Mirena), LNG/EE oral contraceptive pills (Levora) | Drug | Combined Oral Contraceptive pills, Levonorgestrel-intrauterine device |
| DMPA exposureAlso: DMPA (Depo-Provera 150mg IM) | Drug | depot medroxyprogesterone acetate |
| etonogestrel exposureAlso: ENG-implant (Nexplanon or Implanon) | Drug | Etonogestrel contraceptive implant |
| IUD insertionAlso: LNG-IUD (Mirena), Copper T-380A IUD (ParaGard) | Device | Copper intrauterine device, Levonorgestrel-intrauterine device |
| subdermal contraceptive implant insertionAlso: ENG-implant (Nexplanon or Implanon) | Device | Etonogestrel contraceptive implant |
Primary outcome
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
1 secondary outcome
Assessing changes in the vaginal microflora within the first 6 months of contraceptive use
Time frame: baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice Chen, MD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Immune Cells (Mucosal and Systemic), run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification and characterization of immune cell populations and HIV-tropic receptor expression (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.