Conditions: Genital Tract Mucosal Immunity Genital Tract Microflora
Keywords: intrauterine device IUD levonorgestrel copper CD4 CCR5 microflora
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 42
Healthy volunteers: yes

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.

Detailed description:

Arms:
arm 1: Healthy volunteers not at risk of pregnancy and not using any hormonal contraception. arm 2: Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS. arm 3: Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.

Interventions: intervention 1: IUD placement intervention 2: Levonorgestrel IUD intervention 3: Copper T380A IUD
Intervention descriptions: intervention 1: Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard). intervention 2: None intervention 3: None

Protocol document: