Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk

Lisa Haddad

Status and phase: Completed; Phase 4

Conditions: Contraception; HIV

Treatments: Drug: Depot medroxyprogesterone acetate (DMPA); Device: Levonorgestrel intrauterine device (Lng-IUD); Device: Etonogestrel implant (Eng-Implant); Device: ParaGard® T 380A Intrauterine Copper Contraceptive

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02357368

5K23HD078153-05 (U.S. NIH Grant/Contract)

IRB00072549

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 59 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 4 patient groups

Depot medroxyprogesterone acetate (DMPA)

Experimental group

Description:

DMPA will be administered every 12 weeks at 150 mg by intramuscular (IM) injection at week 3 of study enrollment and repeated at week 15.

Treatment:

Drug: Depot medroxyprogesterone acetate (DMPA)

Etonogestrel implant (Eng-Implant)

Experimental group

Description:

A standard Nexplanon rod Implant will be placed at study week 3.

Treatment:

Device: Etonogestrel implant (Eng-Implant)

Levonorgestrel intrauterine device (Lng-IUD)

Experimental group

Description:

A standard Mirena IUD will be placed at study week 3.

Treatment:

Device: Levonorgestrel intrauterine device (Lng-IUD)

ParaGard® T 380A Intrauterine Copper Contraceptive

Experimental group

Description:

A standard ParaGuard IUD will be placed at study week 3.

Treatment:

Device: ParaGard® T 380A Intrauterine Copper Contraceptive