Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk

October 23, 2020 updated by: Lisa Haddad
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 implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and the ParaGard® T 380A Intrauterine Copper Contraceptive impact the vaginal immune environment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic
      • Atlanta, Georgia, United States, 30308
        • The Ponce de Leon Center of the Grady Health System
      • Atlanta, Georgia, United States, 30322
        • Emory University Clinical Research Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 cervicovaginal lavage (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 Centers for Disease Control and Prevention (CDC) medical eligibility criteria or judgment of clinician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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 Names:
  • Depo Provera
EXPERIMENTAL: Etonogestrel implant (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 Names:
  • 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 Names:
  • 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 Names:
  • ParaGuard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood
Time Frame: Week 1, Week 17
Following exposure to HIV, initial infection occurs at the genital mucosa and may involve complex interactions between a number of HIV target immune cells. HIV often uses C-C Chemokine Receptor Type 5 (CCR5) for entrance into target immune cells, causing infection of the cell. The amount of CCR5 expressing macrophages is associated with HIV infection. Cluster of differentiation 4 (CD4) T Cells are targeted and infected by HIV and CD4 percentages are used to assess immune status. CD4 counts vary by individuals and generally decrease with HIV infection.
Week 1, Week 17
Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood
Time Frame: Week 1, Week 17
CD4/CD8 ratios above 1 indicate a strong immune system while lower ratios indicate a viral infection.
Week 1, Week 17
Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood
Time Frame: Week 1, Week 17
T cell activation correlates with HIV infection progression and this study seeks to gain better understanding of these underlying mechanisms by assessment of HIV target cells. Changes in cluster of differentiation 38 (CD38) expression are indicators of HIV disease progression with increases seen in CD38+ when a chronic HIV infection is progressing. Human leukocyte antigen-antigen D related (HLA-DR)+ expression appears to be involved in HIV proliferation.
Week 1, Week 17
Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood
Time Frame: Week 1, Week 17
The concentration levels of interleukin 1 (IL-1) family cytokines and interferon gamma-induced protein 10 (IP-10) chemokines were determined using multiplex Luminex® assays combined with a customized multi-analytical panel of 22 human cytokines and chemokines. IL-1 and IP-10 have been found to influence recruitment of HIV target cells to the female reproductive tract and this study is examining changes in IL-1 and PI-10 to gain further understanding of these mechanisms.
Week 1, Week 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lisa Haddad

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

October 23, 2019

Study Completion (ACTUAL)

October 23, 2019

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 5, 2015

First Posted (ESTIMATE)

February 6, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2020

Last Update Submitted That Met QC Criteria

October 23, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00072549
  • 5K23HD078153-05 (NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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