Contraceptive Hormones, Immunity, and Microbiome Evaluation (CHIME)

Emory University

Status

Completed

Conditions

Hormonal Contraception

Treatments

Drug: Etonogestrel implant (Eng-Implant)

Drug: Depot medroxyprogesterone acetate (DMPA)

Drug: Levonorgestrel IUD (Lng-IUD)

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT03660046

R01HD095741-01A1 (U.S. NIH Grant/Contract)

IRB00104017

Details and patient eligibility

About

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.

Full description

This study is a translational research project to explore the mechanisms underlying the HIV risk associated with pharmacologic doses of exogenous sex hormones (via hormonal contraceptives). Emerging data suggests that certain hormonal contraceptives may induce mucosal and systemic immune changes that could increase the risk of infection with HIV. While several studies have aimed to characterize immunologic changes in women using hormonal contraceptives, the nature and the magnitude of these immune changes have not been adequately defined due to limitations in study design rigor, and small and statistically underpowered sample sizes.

The study will prospectively recruit cohorts of HIV-uninfected women initiating hormonal contraception to characterize systemic and lower genital tract innate and adaptive immunologic changes that occur over a course of up to 4 months. This study will test the overarching hypothesis that hormonal contraceptives induce systemic and mucosal immune changes capable of altering susceptibilities and/or responses to diseases including HIV infection, and that these effects vary markedly in nature and magnitude by contraceptive type and will be modified by the vaginal microenvironment. The main aim is to determine the immunologic alterations in female genital and systemic immune profile associated with depot medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant) and Levonorgestrel IUD (Lng-IUD).

Enrollment

155 patients

Sex

Female

Ages

Under 45 years old

Volunteers

Accepts Healthy Volunteers

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.
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.

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).