Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk

Completed · Phase 4

Conditions studied: HIV, Contraception

In brief

This is a prospective cohort study focusing on HIV negative women. The investigators want to learn how the contraceptive methods of depot medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and the ParaGard® T 380A Intrauterine Copper Contraceptive impact the vaginal immune environment.

Key facts

Study ID

NCT02357368

Run by

Lisa Haddad

People needed

59

Starts

2015-02-01

Expected to finish

2019-10-23

Last updated by the study team

2020-11-18

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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 cervicovaginal lavage (CVL) sampling
• Negative HIV screening

You may not qualify if…

• 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
• 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 Centers for Disease Control and Prevention (CDC) medical eligibility criteria or judgment of clinician

Where it is running

• Grady Health System — Atlanta, Georgia, United States
• The Ponce de Leon Center of the Grady Health System — Atlanta, Georgia, United States
• Emory Clinic — Atlanta, Georgia, United States
• Emory University Clinical Research Network — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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