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| Name | Class |
|---|---|
| University of Zimbabwe | OTHER |
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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 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: Depo-Provera (DMPA), NET-EN, MPA/E2 (Cyclofem®), the levonorgestrel subdermal implant (Jadelle® ), the etonogestrel subdermal implant (Implanon® or Nexplanon® ) and the copper IUD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMPA | Depot medroxyprogesterone acetate |
| |
| NET-EN | Norethisterone enantate |
| |
| MPA/E2 | Medroxyprogesterone acetate and estradiol cypionate |
| |
| LNG-I | Levonorgestrel subdermal implant |
| |
| ENG-I | Etonogestrel subdermal implant |
| |
| Cu-IUD | Copper IUD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMPA | Drug | Depot medroxyprogesterone acetate |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Genital tract CD4 cells (number and % expressing CCR5) | To quantify and characterize immune cell populations and HIV-tropic receptor expression in the genital tract and blood at baseline and after 1, 3 and 6 months of typical contraceptive use. Immune cell populations will be quantified and characterized using flow cytometry. | Change from baseline at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal microbiota (key microbes) | To describe the microflora of the genital tracts of healthy asymptomatic women before and after 1, 3 and 6 months of typical contraceptive use and to assess changes in the vaginal ecology within the first 6-months of contraceptive use. qPCR for key microflora and Nugent scores will be used. | Change from baseline at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
symptomatic candidiasis, trichomoniasis, and symptomatic BV; or cervical infection, including N. gonorrhoeae, Chlamydia 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. Women who have had diagnosed genital infections should have completed treatment at least 30 days before the time of enrollment.
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Healthy women, age 18-34 years, who are HIV negative and non-pregnant.
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Achilles, MD, PhD | University of Pittsburgh | Study Chair |
| Felix Mhlanga, MD | University of Zimbabwe, University of California San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ UCSF | Harare | Zimbabwe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32533883 | Derived | Achilles SL, Meyn LA, Mhlanga FG, Matubu AT, Stoner KA, Beamer MA, Chirenje ZM, Hillier SL. Zim CHIC: A cohort study of immune changes in the female genital tract associated with initiation and use of contraceptives. Am J Reprod Immunol. 2020 Sep;84(3):e13287. doi: 10.1111/aji.13287. Epub 2020 Jun 25. |
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| ID | Term |
|---|---|
| C050795 | N,N-dimethyl-4-anisidine |
| C024319 | norethindrone enanthate |
| D017258 | Medroxyprogesterone Acetate |
| C007630 | estradiol 17 beta-cypionate |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
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whole blood, plasma archive, vaginal swabs, serum, cervicovaginal lavage fluid
| NET-EN | Drug | Norethisterone enantate |
|
|
| MPA/E2 | Drug | Medroxyprogesterone acetate and estradiol cypionate |
|
|
| LNG-I | Device | Levonorgestrel subdermal implant |
|
|
| ENG-I | Device | Etonogestrel subdermal implant |
|
|
| Cu-IUD | Device | Copper IUD |
|
|
| Serum hemoglobin | To objectively assess blood count before and at 1,3,and 6 months following initiation of each contraceptive method. Standard clinical complete blood count (CBC) will be obtained at each visit. | Change from baseline at 6 months |
| Serum concentration of estradiol and progesterone/progestin | To assess relative serum concentrations of endogenous and exogenous sex hormones before and after contraceptive use. Hormonal concentrations will be assessed by measuring blood levels of estrogen and progesterone as well as blood levels of the contraceptive progestin corresponding to the cohort group for that participant. | Change from baseline at 3 months |
| D011283 |
| Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |