Overview

Hormonal Contraceptive Methods on Immunologic Changes in the Female Genital Tract (FGT) and Systemically

Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
0
Participant gender:
Female
Summary
The study is a prospective cohort study to explore the mechanisms underlying the HIV risk associated with pharmacologic doses of exogenous sex hormones via hormonal contraceptives specially progestin-containing hormonal contraception (HC). The study seeks to test that HC induce immunologic changes capable of altering HIV susceptibilities, that these effects will vary by contraceptive type, and that they will be modified by the vaginal microenvironment.
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Emory University
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
Treatments:
Contraceptive Agents
Copper
Desogestrel
Etonogestrel
Levonorgestrel
Medroxyprogesterone
Medroxyprogesterone Acetate
Criteria
Inclusion Criteria:

- Female sex, defined by sex at birth

- Age ≤ 45 years. If < 18 years of age, participant must be capable of providing assent,
understanding and complying with all study procedures, and have written informed
consent from a parent or legal guardian.

- Normal menses (occurring within 22-35 day intervals) for > 2 cycles. Women who are
postpartum or post-abortion who have resumed menses are eligible.

- Intact uterus and cervix, (e) Interested in initiating HC and willing to accept DMPA,
Eng-Implant or Lng-IUD

- Willing to delay initiation of HC for up to 1 month

- Interested in initiating HC and willing to accept DMPA, Eng-Implant or Lng-IUD

- Able and willing to provide informed consent, and undergo study procedures. See
criterion (b) for participants <18 years of age.

- Negative HIV test by Ora-Quick© method at Screening Visit.

- Agree to abstain from vaginal intercourse or using intra-vaginal products for 1 day
prior to each study visit

Exclusion Criteria:

- Pregnant or planning to become pregnant within the next year

- Breastfeeding, if not having active menstrual cycles. Breastfeeding is not
exclusionary if the participant is actively cycling.

- History of loop electrosurgical excision procedure (LEEP), conization, or cryosurgery
within the past year

- Current use of systemic HC or IUD, based on self-report and/or hormonal testing

- Taking concurrent medications that interact with selected HC

- Contraindications to selected contraceptive per the Center for Disease Control medical
eligibility criteria or judgment of clinician.

- Allergy to lidocaine for cervical biopsies (if consenting to optional biopsies).