Status:
TERMINATED
Contraceptive/HIV Affecting Risk in Adolescents
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Contraception
Hiv
Eligibility:
FEMALE
18-45 years
Brief Summary
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 evalu...
Eligibility Criteria
Inclusion
- Meets one of the following age groups (at the time of sample collection):
- Adolescent aged 18-19
- Adult aged 25-45
- Meets one of the following contraception groups:
- Regular menstrual cycles by participant history (if not using hormonal contraception)
- Use of ENG-I (i.e. Implanon/Nexplanon) for at least 30 days by participant history
- Use of LNG-IUS (Mirena or Skyla) for at least 30 days by participant history
- 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.
- Willing to undergo pelvic exam and collection of cervical biopsies
- Willing to provided written informed consent
- Agree to be sexually abstinent for 48 hours prior to the cervical biopsies and for one week after the biopsies.
Exclusion
- Use of any other hormonal contraception other than ENG-I or LNG-IUS
- Use of a diaphragm or spermicide for contraception
- Pregnant or pregnancy within 90 days
- Currently breastfeeding
- Currently menstruating/bleeding (at time of specimen collection) Note: participant can return after cessation of bleeding for specimen collection
- Past participation in more than one study involving cervical biopsies per participant report
- Cervical biopsies within one month of specimen collection visit
- Abnormal vaginal discharge or other genital tract symptoms at the time of specimen collection
- Pelvic findings on the day of specimen collection consistent with cervicitis (i.e. MPC, erythema, edema) or anatomy making cervical biopsies difficult
- Menopausal
- Hysterectomy
- History of malignancy of the genital tract (including cervix, uterus, vagina, and vulva)
- History of immunosuppression (including HIV infection, diabetes, and chronic steroid use)
- Known history of a platelet/bleeding/clotting disorder
- Use of a systemic or vaginal antimicrobial agent within 7 days of specimen collection
- Use of any vaginal product (i.e. douching, spermicide, lubricant) or device within 7 days of specimen collection Note: tampon use is acceptable
- 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.
Key Trial Info
Start Date :
July 31 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 17 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03301480
Start Date
July 31 2017
End Date
September 17 2018
Last Update
February 7 2019
Active Locations (1)
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1
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213