Contraceptive/HIV Affecting Risk in Adolescents



Status:Terminated
Conditions:Contraception, Contraception, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Reproductive
Healthy:No
Age Range:18 - 45
Updated:2/9/2019
Start Date:July 31, 2017
End Date:September 17, 2018

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This study will evaluate the impact of hormonal contraceptives on HIV risk associated with
changes to the innate immunity in the female genital tract in a cross-sectional study. HIV
risk will be evaluated by the capacity of cervical tissue to replicate HIV when challenged ex
vivo and correlated to the number of CD4 T cells, DCs, and macrophages; the capacity of
cervicovaginal fluid to inhibit HIV will be correlated to soluble mucosal mediators, and the
vaginal microbiota. The lower genital tract samples will be collected from 120 adolescents
aged 18-19 (40 using no hormonal contraception, 40 using ENG-I, 40 using LNG-IUS). For
comparison, 90 adult women aged 25-45 will be equally distributed between the same groupings.


Inclusion Criteria:

1. Meets one of the following age groups (at the time of sample collection):

1. Adolescent aged 18-19

2. Adult aged 25-45

2. Meets one of the following contraception groups:

1. Regular menstrual cycles by participant history (if not using hormonal
contraception)

2. Use of ENG-I (i.e. Implanon/Nexplanon) for at least 30 days by participant
history

3. Use of LNG-IUS (Mirena or Skyla) for at least 30 days by participant history

3. HIV uninfected Note: HIV testing will be done as part of screening. However, if a
woman participated in a recent research study and has an HIV test result available
from that study, this will suffice provided the date of the test is within 6 months of
the study visit.

4. Willing to undergo pelvic exam and collection of cervical biopsies

5. Willing to provided written informed consent

6. Agree to be sexually abstinent for 48 hours prior to the cervical biopsies and for one
week after the biopsies.

Exclusion Criteria:

1. Use of any other hormonal contraception other than ENG-I or LNG-IUS

2. Use of a diaphragm or spermicide for contraception

3. Pregnant or pregnancy within 90 days

4. Currently breastfeeding

5. Currently menstruating/bleeding (at time of specimen collection) Note: participant can
return after cessation of bleeding for specimen collection

6. Past participation in more than one study involving cervical biopsies per participant
report

7. Cervical biopsies within one month of specimen collection visit

8. Abnormal vaginal discharge or other genital tract symptoms at the time of specimen
collection

9. Pelvic findings on the day of specimen collection consistent with cervicitis (i.e.
MPC, erythema, edema) or anatomy making cervical biopsies difficult

10. Menopausal

11. Hysterectomy

12. History of malignancy of the genital tract (including cervix, uterus, vagina, and
vulva)

13. History of immunosuppression (including HIV infection, diabetes, and chronic steroid
use)

14. Known history of a platelet/bleeding/clotting disorder

15. Use of a systemic or vaginal antimicrobial agent within 7 days of specimen collection

16. Use of any vaginal product (i.e. douching, spermicide, lubricant) or device within 7
days of specimen collection Note: tampon use is acceptable

17. Any other condition that in the opinion of the Study Investigator would preclude
provision of informed consent or make study participation unsafe, complicate the
interpretation of study outcome data, or otherwise interfere with achieving the study
objectives.
We found this trial at
1
site
300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Phone: 412-641-5455
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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from
Pittsburgh, PA
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