Phase 4 N=59 Basic Science

Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk

HIV · Contraception

Bottom Line

View on ClinicalTrials.gov: NCT02357368 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood — 26.6; 22.8; 16.9; 22.4 percentage of HIV target immune cells

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Depot medroxyprogesterone acetate (DMPA) (Drug); Etonogestrel implant (Eng-Implant) (Device); Levonorgestrel intrauterine device (Lng-IUD) (Device); ParaGard® T 380A Intrauterine Copper Contraceptive (Device)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Lisa Haddad
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood	26.6; 22.8; 16.9; 22.4; 39.2; 32.2	—
PRIMARY Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood	2.4; 2.6; 2.9; 3.9; 2.6; 2.3	—
PRIMARY Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood	36.7; 36.9; 32.6; 23.2; 35.9; 41.7	—
PRIMARY Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood	689.8; 2551.1; 1100.2; 445.8; 2417.6; 1241.5	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02357368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.