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Clinical trial

A Prospective Cohort Study Evaluating the Impact of Three Progestin-based Hormonal Contraceptive (HC) Methods on Immunologic Changes in the Female Genital Tract (FGT) and Systemically

ID
Name
IRB00104017
Description
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.
Trial arms
Trial start
2018-12-07
Estimated PCD
2024-09-01
Trial end
2024-09-01
Status
Recruiting
Treatment
Depot medroxyprogesterone acetate (DMPA)
Depot medroxyprogesterone acetate (DMPA) will be dispensed from the Grady Pharmacy Service and will be administered every 12 weeks at the standard dose of 150 mg Intramuscular injection, beginning from week 3 of study enrollment and repeated every 13 weeks
Arms:
Depot medroxyprogesterone acetate (DMPA)
Other names:
Medroxyprogesterone acetate (MPA), Depo-Provera
Etonogestrel implant (Eng-Implant)
A standard Nexplanon rod Implant that is a subdermal implant in the arm. This will be placed at study week 3 by Dr. Haddad or a trained clinician. It contains Etonogestrel 68mg.
Arms:
Etonogestrel implant (Eng-Implant)
Other names:
Nexplanon
Levonorgestrel IUD (Lng-IUD)
The Levonorgestrel Intrauterine Device (Lng-IUD) (Mirena or copper) will be placed at study week 3 by Dr. Haddad or a trained clinician.
Arms:
Levonorgestrel IUD (Lng-IUD)
Other names:
Mirena, Copper
Size
225
Primary endpoint
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
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
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
Week 1 and Week 3 (pre contraception), and 13 and 15 weeks after initiating contraception
Eligibility 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. * 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).
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 225, 'type': 'ESTIMATED'}}
Updated at
2023-09-13

1 organization

3 products

1 indication

Organization
Emory University
Product
Depot medroxyprogesterone acetate
Indication
Hormonal Contraception
Product
Etonogestrel implant
Product
Levonorgestrel IUD