Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
Status: | Recruiting |
---|---|
Conditions: | Contraception, Contraception, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 3/22/2019 |
Start Date: | February 2015 |
End Date: | March 2020 |
Contact: | Rachael A Farah-Abraham, PhD |
Email: | rfarahabraham@emory.edu |
Phone: | 404-251 8940 |
This is a prospective cohort study focusing on HIV negative women. The investigators want to
learn how the following types of contraceptive methods: Depot medroxyprogesterone acetate
(DMPA), Etonogestrel impant (Eng-Implant), Levonorgestrel intrauterine device (Lng-IUD) and
the ParaGard® T 380A Intrauterine Copper Contraceptive impacts the vaginal immune
environment.
learn how the following types of contraceptive methods: Depot medroxyprogesterone acetate
(DMPA), Etonogestrel impant (Eng-Implant), Levonorgestrel intrauterine device (Lng-IUD) and
the ParaGard® T 380A Intrauterine Copper Contraceptive impacts the vaginal immune
environment.
The three proposed aims will evaluate the effect of four contraceptive methods: Depot
medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant), Levonorgestrel
intrauterine device (Lng-IUD) and ParaGard® T 380A Intrauterine Copper Contraceptive on: (1)
HIV target immune cells within the female genital mucosa; (2) markers of T-cell activation
and trafficking within the female genital mucosa; and (3) secreted cytokines and chemokines
within the female genital mucosa.
medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant), Levonorgestrel
intrauterine device (Lng-IUD) and ParaGard® T 380A Intrauterine Copper Contraceptive on: (1)
HIV target immune cells within the female genital mucosa; (2) markers of T-cell activation
and trafficking within the female genital mucosa; and (3) secreted cytokines and chemokines
within the female genital mucosa.
Inclusion Criteria:
- Female
- Age 18-45 years
- Normal menses (22-35 day intervals) for at least 3 cycles
- Intact uterus and cervix
- Interested in to DMPA, Eng-Implant or Lng-IUD or ParaGuard
- Willing to delay initiation of hormonal contraception for up to 1 month
- Willing to use condoms or abstain from sexual intercourse for at least 48 hours before
each genital tract sampling (condoms will be made available)
- Able and willing to provide informed consent, and undergo serial blood and CVL
sampling
- Negative HIV screening.
Exclusion Criteria:
- Pregnant within the last 3 months
- Breastfeeding
- History of loop electrosurgical excision procedure, conization, or cryosurgery within
the past year
- Use of hormonal contraception or IUD in the past 6 months or,
- Known history of medical condition that would interfere with the conduct of the study
- Symptomatic vaginal infection or genital ulcer disease at screening
- Taking medications that interact with selected contraceptive
- Contraindications to selected contraceptive per the CDC medical eligibility
criteria(67) or judgment of clinician.
We found this trial at
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