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.
Study Type
OBSERVATIONAL
Enrollment
451
Depot medroxyprogesterone acetate
Norethisterone enantate
Medroxyprogesterone acetate and estradiol cypionate
Levonorgestrel subdermal implant
Etonogestrel subdermal implant
Copper IUD
UZ UCSF
Harare, Zimbabwe
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.
Time frame: Change from baseline at 3 months
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.
Time frame: Change from baseline at 3 months
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.
Time frame: 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.
Time frame: Change from baseline at 3 months
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