Study of Immune Cell Changes in the Genital Tract 2 Months After Initiation of an IUD for Contraception (CHIC)

Sharon Achilles

Status: Completed

Conditions: Genital Tract Mucosal Immunity; Genital Tract Microflora

Treatments: Drug: Levonorgestrel IUD; Drug: IUD placement; Drug: Copper T380A IUD

Study type: Interventional

Funder types: Other

Identifiers

NCT01240811

PRO09100199

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Non-pregnant, healthy females who are seeking an IUD for contraception
2. Age 18-40 years, inclusive at the time of enrollment
3. 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
4. Willing and able to sign the informed consent and to comply with the study protocol

Inclusion criteria for healthy control subjects:

1. Non-pregnant, healthy females
2. Age 18-40 years, inclusive at the time of enrollment
3. 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
4. Willing and able to sign the informed consent and to comply with the study protocol
5. Prior surgical sterilization or heterosexually abstinent

Exclusion criteria

1. Use of any hormonal or intrauterine contraceptive method within the past two months

2. Use of DMPA within the past 10 months

3. 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

4. Evidence of vaginal/pelvic infection on screening

   • Abnormal wet mount (see description above)
   • Pelvic exam findings clinically consistent with infection
   • Positive screen for Gc, Ct, or HIV (will be excluded post randomization)

5. Active HSV/ulcerative disease in the genital tract or perineum

6. History of immunosuppression (diabetes, HIV, chronic steroid use)

7. Use of vaginal product (N9, microbicide, douche, antifungal, steroid, or hormone) within the past 30 days

8. Use of any systemic or vaginal steroid or antibiotic within the past 30 days

9. Vaginal or anal intercourse within 1 week of sample collection

10. Heterosexual vaginal intercourse since last menses without condom use

11. History of hysterectomy

12. History of malignancy in the uterus or cervix

13. Uterine anomaly (bicornuate uterus, uterine septum, or uterine didelphys)

14. Allergy to copper and/or intolerance to levonorgestrel

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Control-No IUD

No Intervention group

Description:

Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.

Levonorgestrel IUS

Experimental group

Description:

Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.

Treatment:

Drug: Levonorgestrel IUD

Drug: IUD placement

Copper T380A IUD

Experimental group

Description:

Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.

Treatment:

Drug: Copper T380A IUD

Drug: IUD placement