Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
NCT ID: NCT02357368
Last Updated: 2020-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
59 participants
INTERVENTIONAL
2015-02-28
2019-10-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Depot medroxyprogesterone acetate (DMPA)
DMPA will be administered every 12 weeks at 150 mg by intramuscular (IM) injection at week 3 of study enrollment and repeated at week 15.
Depot medroxyprogesterone acetate (DMPA)
DMPA will be administered every 12 weeks at the standard dose of 150 mg IM, beginning from week 3 of study enrollment and repeated at week 15.
Etonogestrel implant (Eng-Implant)
A standard Nexplanon rod Implant will be placed at study week 3.
Etonogestrel implant (Eng-Implant)
A standard nexplanon rod implant will be placed at study week 3 by a trained clinician.
Levonorgestrel intrauterine device (Lng-IUD)
A standard Mirena IUD will be placed at study week 3.
Levonorgestrel intrauterine device (Lng-IUD)
A standard Mirena IUD will be placed at study week 3 by a trained clinician.
ParaGard® T 380A Intrauterine Copper Contraceptive
A standard ParaGuard IUD will be placed at study week 3.
ParaGard® T 380A Intrauterine Copper Contraceptive
A standard ParaGuard IUD will be placed at study week 3 by a trained clinician.
Interventions
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Depot medroxyprogesterone acetate (DMPA)
DMPA will be administered every 12 weeks at the standard dose of 150 mg IM, beginning from week 3 of study enrollment and repeated at week 15.
Etonogestrel implant (Eng-Implant)
A standard nexplanon rod implant will be placed at study week 3 by a trained clinician.
Levonorgestrel intrauterine device (Lng-IUD)
A standard Mirena IUD will be placed at study week 3 by a trained clinician.
ParaGard® T 380A Intrauterine Copper Contraceptive
A standard ParaGuard IUD will be placed at study week 3 by a trained clinician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-45 years
* Normal menses (22-35 day intervals) for at least 3 cycles
* Intact uterus and cervix
* Interested in to DMPA, Eng-Implant or Lng-IUD or ParaGuard
* Willing to delay initiation of hormonal contraception for up to 1 month
* Willing to use condoms or abstain from sexual intercourse for at least 48 hours before each genital tract sampling (condoms will be made available)
* Able and willing to provide informed consent, and undergo serial blood and cervicovaginal lavage (CVL) sampling
* Negative HIV screening
Exclusion Criteria
* Breastfeeding
* History of loop electrosurgical excision procedure, conization, or cryosurgery within the past year
* Use of hormonal contraception or IUD in the past 6 months
* Known history of medical condition that would interfere with the conduct of the study
* Symptomatic vaginal infection or genital ulcer disease at screening
* Taking medications that interact with selected contraceptive
* Contraindications to selected contraceptive per the Centers for Disease Control and Prevention (CDC) medical eligibility criteria or judgment of clinician
18 Years
45 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Lisa Haddad
OTHER
Responsible Party
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Lisa Haddad
Asscoiate Professor
Principal Investigators
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Lisa Haddad, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Grady Health System
Atlanta, Georgia, United States
The Ponce de Leon Center of the Grady Health System
Atlanta, Georgia, United States
Emory Clinic
Atlanta, Georgia, United States
Emory University Clinical Research Network
Atlanta, Georgia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00072549
Identifier Type: -
Identifier Source: org_study_id