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

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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.

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.

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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Atlanta, Georgia 30303
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Atlanta, Georgia 30322
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