Impact of Intrauterine Contraception on the Immune Environment of the Female Genital Tract
Overview
- Phase
- Not Applicable
- Intervention
- IUD placement
- Conditions
- Genital Tract Mucosal Immunity
- Sponsor
- Sharon Achilles
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- %CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This pilot study is being performed to investigate the influence that starting contraception with an IUD has on the local immune cell populations and features, with a particular focus on the cells and cell-surface features that are important in HIV transmission (CD4 cells and CCR5 cell receptors).
Based on results from large epidemiologic studies there seems to be a consistent finding of slightly increased HIV acquisition in women who use hormonal contraception. It is not clear if this is due to a biological phenomenon or if it relates to a difference in sexual behaviors/risks of women on hormonal contraceptives.
The study hypothesis is that CD4 cells and CCR5 HIV-tropic receptor density increases within the upper and lower genital tract of women 2 months after placement of progestin-containing intrauterine devices for contraception as compared with women not using hormonal contraception.
Investigators
Sharon Achilles
Assistant Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Non-pregnant, healthy females who are seeking an IUD for contraception
- •Age 18-40 years, inclusive at the time of enrollment
- •History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
- •Willing and able to sign the informed consent and to comply with the study protocol
- •Inclusion criteria for healthy control subjects:
- •Non-pregnant, healthy females
- •Age 18-40 years, inclusive at the time of enrollment
- •History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days
- •Willing and able to sign the informed consent and to comply with the study protocol
- •Prior surgical sterilization or heterosexually abstinent
Exclusion Criteria
- •Use of any hormonal or intrauterine contraceptive method within the past two months
- •Use of DMPA within the past 10 months
- •Any of the following within the past two months:
- •Pregnancy or breastfeeding
- •Surgery/biopsy of the vulva, vagina, or cervix
- •History of STI
- •New sexual partner
- •Evidence of vaginal/pelvic infection on screening
- •Abnormal wet mount (see description above)
- •Pelvic exam findings clinically consistent with infection
Arms & Interventions
Levonorgestrel IUS
Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
Intervention: IUD placement
Levonorgestrel IUS
Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
Intervention: Levonorgestrel IUD
Copper T380A IUD
Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
Intervention: IUD placement
Copper T380A IUD
Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
Intervention: Copper T380A IUD
Outcomes
Primary Outcomes
%CD4 Expressing CCR5 HIV Co-receptor in the Cervix and Endometrium
Time Frame: 2 months
Change in CCR5 expression on T-lymphocytes 2 months after insertion of IUD (either hormonal LNG-IUD or non-hormonal Cu-IUD) in cervix and endometrium as measured by flow cytomety
Secondary Outcomes
- Change in Quantities of Vaginal H2O2-producing Lactobacillus Species and Gardnerella Vaginalis(2 Months)
- Change in Vaginal Flora(2 Months)