Contraceptive Hormones, Immunity, and Microbiome Evaluation
NCT ID: NCT03660046
Last Updated: 2024-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
155 participants
OBSERVATIONAL
2018-12-07
2023-09-07
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Depot medroxyprogesterone acetate (DMPA)
This arm includes subjects that choose Depot medroxyprogesterone acetate (DMPA) as contraception.
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
Etonogestrel implant (Eng-Implant)
This arm includes subjects that choose Etonogestrel implant (Eng-Implant) as contraception.
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.
Levonorgestrel IUD (Lng-IUD)
This arm includes subjects that choose Levonorgestrel Intrauterine device (Lng-IUD) as contraception.
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.
Interventions
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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
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
45 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Emory University
OTHER
Responsible Party
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Alicia K Smith
Associate Professor
Principal Investigators
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Alicia Smith, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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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
Countries
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Other Identifiers
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IRB00104017
Identifier Type: -
Identifier Source: org_study_id
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