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Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02357368
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Lisa Haddad, Emory University

Brief Summary:
This is a prospective cohort study focusing on HIV negative women. The investigators want to learn how the contraceptive methods of depot medroxyprogesterone acetate (DMPA), etonogestrel impant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and the ParaGard® T 380A Intrauterine Copper Contraceptive impact the vaginal immune environment.

Condition or disease Intervention/treatment Phase
HIV Contraception Drug: Depot medroxyprogesterone acetate (DMPA) Device: Etonogestrel implant (Eng-Implant) Device: Levonorgestrel intrauterine device (Lng-IUD) Device: ParaGard® T 380A Intrauterine Copper Contraceptive Phase 4

Detailed Description:
The three proposed aims will evaluate the effect of four contraceptive methods (depot medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and ParaGard® T 380A Intrauterine Copper Contraceptive) on: (1) HIV target immune cells within the female genital mucosa; (2) markers of T-cell activation and trafficking within the female genital mucosa; and (3) secreted cytokines and chemokines within the female genital mucosa.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
Study Start Date : February 2015
Actual Primary Completion Date : October 23, 2019
Actual Study Completion Date : October 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Depot medroxyprogesterone acetate (DMPA)
DMPA will be administered every 12 weeks at 150 mg IM at week 3 of study enrollment and repeated at week 15.
Drug: 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.
Other Name: Depo Provera

Experimental: Etonogestrel impant (Eng-Implant)
A standard Nexplanon rod Implant will be placed at study week 3.
Device: Etonogestrel implant (Eng-Implant)
A standard nexplanon rod implant will be placed at study week 3 by a trained clinician.
Other Name: Nexplanon

Experimental: Levonorgestrel intrauterine device (Lng-IUD)
A standard Mirena IUD will be placed at study week 3.
Device: Levonorgestrel intrauterine device (Lng-IUD)
A standard Mirena IUD will be placed at study week 3 by a trained clinician.
Other Name: Mirena

Experimental: ParaGard® T 380A Intrauterine Copper Contraceptive
A standard ParaGuard IUD will be placed at study week 3.
Device: ParaGard® T 380A Intrauterine Copper Contraceptive
A standard ParaGuard IUD will be placed at study week 3 by a trained clinician.
Other Name: ParaGuard




Primary Outcome Measures :
  1. Change in HIV target immune cells--CCR5 expressing macrophages and dendritic cells (DCs) including myeloid DCs and Langerhans cells (LCs) [ Time Frame: Week 1, Week 17 ]
    For assessment of HIV target cells, samples will be stained with a Live/Dead viability dye and fluorochrome labeled antibodies against CD3, CD4, CD27, CD45RA, CCR5 and CXCR4. Effector memory (CD45RA-/CD27-) CD3+CD4+ cells will be analyzed for surface expression of HIV co-receptors.

  2. Change in total CD4+ T cells [ Time Frame: Week 1, Week 17 ]
    For assessment of HIV target cells, samples will be stained with a Live/Dead viability dye and fluorochrome labeled antibodies against CD3, CD4, CD27, CD45RA, CCR5 and CXCR4. CCR5 and CXCR4 will be analyzed for surface expression of total CD4+ T cells

  3. Change in concentration levels of cytokines and chemokines--Interleukin 1 family (IL-1) and Interleukin 10 (IP10) [ Time Frame: Week 1, Week 17 ]
    Using multiplex Luminex® assays combined with a customized multi-analytical panel of 22 human cytokines and chemokines, investigators will quantify concentrations of cytokines and chemokines in plasma and CVL supernatant



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • 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 CVL sampling
  • Negative HIV screening

Exclusion Criteria:

  • Pregnant within the last 3 months
  • 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 CDC medical eligibility criteria or judgment of clinician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357368


Locations
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United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
The Ponce de Leon Center of the Grady Health System
Atlanta, Georgia, United States, 30308
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Clinical Research Network
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Lisa Haddad
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Lisa Haddad, MD Emory University
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Responsible Party: Lisa Haddad, Asscoiate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02357368    
Other Study ID Numbers: IRB00072549
1R01HD095741-01A1 ( U.S. NIH Grant/Contract )
5K23HD078153-05 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Lisa Haddad, Emory University:
HIV-negative
Additional relevant MeSH terms:
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Copper
Medroxyprogesterone Acetate
Contraceptive Agents
Levonorgestrel
Medroxyprogesterone
Etonogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Micronutrients
Nutrients
Growth Substances
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents