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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Oral Contraceptive pills | Levonorgestrel/ethinyl estradiol 0.15mg/30mcg daily oral tabs x21 then 7 inert tabs |
| |
| depot medroxyprogesterone acetate | 150mg DMPA intramuscular injection once every 3 months |
| |
| Levonorgestrel-intrauterine device | 52mg levonorgestrel intrauterine device |
| |
| Copper intrauterine device | Copper T380A intrauterine device |
| |
| Etonogestrel contraceptive implant | 68mg etonogestrel subdermal implant |
| |
| Control | Low risk of pregnancy due to sterilization, heterosexual abstinence, or consistent condom use |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levonorgestrel exposure | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reproductive tract Microenvironment | 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 |
Inclusion Criteria:
Exclusion Criteria:
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Healthy women, age 18-34 years, who are HIV negative and non-pregnant.
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| Name | Affiliation | Role |
|---|---|---|
| Beatrice Chen, MD, MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Family Planning Research | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| C050795 | N,N-dimethyl-4-anisidine |
| D017258 | Medroxyprogesterone Acetate |
| C044815 | etonogestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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whole blood, plasma archive, vaginal swabs, serum
| DMPA exposure | Drug |
|
|
| etonogestrel exposure | Drug |
|
|
| IUD insertion | Device |
|
|
| subdermal contraceptive implant insertion | Device |
|
|
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |