Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk

• Status: Completed
• Trial end date: 2019-10-23
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lisa Haddad
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Contraceptive Agents; Copper; Etonogestrel; Levonorgestrel; Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

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 cervicovaginal lavage (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

• 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