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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

Tracking Information
First Submitted Date  ICMJE February 3, 2015
First Posted Date  ICMJE February 6, 2015
Last Update Posted Date April 27, 2020
Study Start Date  ICMJE February 2015
Actual Primary Completion Date October 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2015)
  • 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.
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
Official Title  ICMJE Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • HIV
  • Contraception
Intervention  ICMJE
  • 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
  • Device: Etonogestrel implant (Eng-Implant)
    A standard nexplanon rod implant will be placed at study week 3 by a trained clinician.
    Other Name: Nexplanon
  • Device: Levonorgestrel intrauterine device (Lng-IUD)
    A standard Mirena IUD will be placed at study week 3 by a trained clinician.
    Other Name: Mirena
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Depot medroxyprogesterone acetate (DMPA)
  • Experimental: Etonogestrel impant (Eng-Implant)
    A standard Nexplanon rod Implant will be placed at study week 3.
    Intervention: Device: Etonogestrel implant (Eng-Implant)
  • Experimental: Levonorgestrel intrauterine device (Lng-IUD)
    A standard Mirena IUD will be placed at study week 3.
    Intervention: Device: Levonorgestrel intrauterine device (Lng-IUD)
  • Experimental: ParaGard® T 380A Intrauterine Copper Contraceptive
    A standard ParaGuard IUD will be placed at study week 3.
    Intervention: Device: ParaGard® T 380A Intrauterine Copper Contraceptive
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2020)
93
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2015)
90
Actual Study Completion Date  ICMJE October 23, 2019
Actual Primary Completion Date October 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02357368
Other Study ID Numbers  ICMJE IRB00072549
1R01HD095741-01A1 ( U.S. NIH Grant/Contract )
5K23HD078153-05 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisa Haddad, Emory University
Study Sponsor  ICMJE Lisa Haddad
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Lisa Haddad, MD Emory University
PRS Account Emory University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP