Contraceptive Hormones, Immunity, and Microbiome Evaluation

Completed

Conditions studied: Hormonal Contraception

In brief

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.

Key facts

Study ID

NCT03660046

Run by

Emory University

People needed

155

Starts

2018-12-07

Expected to finish

2023-09-07

Last updated by the study team

2024-10-29

Who can join

Age: any, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.
• Able and willing to provide informed consent, and undergo study procedures.
• 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.

You may not qualify if…

• 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).

Where it is running

• Grady Health System — Atlanta, Georgia, United States
• The Emory Clinic, Bldg A., 2nd Floor, 1365 Clifton Road, NE — Atlanta, Georgia, United States
• Atlanta Women's Center — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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