CompletedNot Applicable

Contraceptive Hormones, Immunity, and Microbiome Evaluation

United States155 participantsStarted 2018-12-07

Plain-language 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.

Who can participate

Age range

45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in mean total leukocytes and CD4+ T-cells expressing CCR5 in the lower female genital tract (FGT) among the three intervention groups pre and post contraception

Timeframe: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception

Change in Nugent's score among the three intervention groups pre and post contraception

Timeframe: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception

Percent of expression of 16S rRNA gene sequencing among the three intervention groups pre and post contraception

Timeframe: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception

Trial details

NCT IDNCT03660046

SponsorEmory University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-07

View on ClinicalTrials.gov More Hormonal Contraception trials

Plain-language summary

Who can participate

Age range

45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in mean total leukocytes and CD4+ T-cells expressing CCR5 in the lower female genital tract (FGT) among the three intervention groups pre and post contraception

Timeframe: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception

Change in Nugent's score among the three intervention groups pre and post contraception

Timeframe: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception

Percent of expression of 16S rRNA gene sequencing among the three intervention groups pre and post contraception

Timeframe: Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception