Phase 4
Completed N=59
Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
Source: ClinicalTrials.gov NCT02357368 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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
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. Informational only — not medical advice.