HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC (Zim CHIC)

December 1, 2020 updated by: Sharon Achilles, University of Pittsburgh

This study is being done to understand if using birth control causes changes in the immune cells within the reproductive tract of healthy women. Immune cells are important because they help prevent infections from starting and help fight infections that have started. Immune cells are also the type of cells that HIV (human immunodeficiency virus) infects so understanding more about them will help to better understand how to prevent the spread of HIV.

Immune cells will be studied from the reproductive tract of women who want to start using one of the following contraceptives: Depo-Provera (DMPA), NET-EN, MPA/E2 (Cyclofem®), the levonorgestrel subdermal implant (Jadelle® ), the etonogestrel subdermal implant (Implanon® or Nexplanon® ) and the copper IUD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

451

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

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 34 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy women, age 18-34 years, who are HIV negative and non-pregnant.

Description

Inclusion Criteria:

  • Age 18 through 34 years (inclusive) at screening
  • Non-pregnant women in general good health as determined by the site clinician
  • Premenopausal with history of regular menstrual cycles (regular cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days)
  • Able and willing to provide written informed consent to be screened for and to take part in the study. Including willingness to undergo all study-related assessments and follow all study-related procedures
  • Able and willing to provide adequate locator information
  • HIV-uninfected based on testing performed by study staff at screening
  • At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products while enrolled in this trial

Exclusion Criteria:

  • Use of any hormonal or intrauterine contraceptive method within 30 days of enrollment
  • Use of DMPA or NET-EN within 10 months of enrollment
  • Pregnancy or breastfeeding within 60 days of enrollment
  • Surgical procedure involving the pelvis in the 30 days prior to enrollment (includes dilation and curettage, cryosurgery and biopsy of the vagina, vulva, cervix, and endometrium)
  • Internal vaginal use of any device (includes sex toys, cervical caps, diaphragms, menstrual collection devices, and pessaries; excludes tampons and condoms) or product (includes N9, microbicide, douche, antifungal, steroid, or hormone) in the 30 days prior to enrollment
  • New sexual partner within 90 days of enrollment
  • Urogenital infection or suspected infection within 30 days of enrollment including:

symptomatic candidiasis, trichomoniasis, and symptomatic BV; or cervical infection, including N. gonorrhoeae, Chlamydia trachomatis, or mucopurulent cervicitis; syphilis; HSV lesions, or other sores (Note: seropositive HSV without active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract infection; recent exposure to a partner with GC, CT, Trichomonas, syphilis, or NGU. Women who have had diagnosed genital infections should have completed treatment at least 30 days before the time of enrollment.

  • Any history of immunosuppression (includes diabetes, HIV infection, and chronic steroid use)
  • Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment
  • Menses or other vaginal bleeding at the time of Enrollment* (*Women who have vaginal bleeding at the scheduled Enrollment Visit may return at a different date to be re-examined and possibly enrolled provided they are still within the 90-day screening window and meet all criteria).
  • Vaginal or anal intercourse within 2 days (48 hours) prior to enrollment
  • Heterosexual intercourse since last menses that places the participant at risk of pregnancy (without condom use or sterilization of at least one partner)
  • History of hysterectomy
  • History of malignancy within the pelvis (includes uterus, cervix, vagina, and vulva)
  • Contraindication, allergy or intolerance to use of the contraceptive desired by the participant
  • Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DMPA
Depot medroxyprogesterone acetate
Drug: DMPA
Depot medroxyprogesterone acetate
Other Names:
  • Depot medroxyprogesterone acetate (DMPA)
NET-EN
Norethisterone enantate
Drug: NET-EN
Norethisterone enantate
Other Names:
  • Norethisterone enantate (NET-EN)
MPA/E2
Medroxyprogesterone acetate and estradiol cypionate
Drug: MPA/E2
Medroxyprogesterone acetate and estradiol cypionate
Other Names:
  • Medroxyprogesterone acetate and estradiol cypionate (MPA/E2)
LNG-I
Levonorgestrel subdermal implant
Device: LNG-I
Levonorgestrel subdermal implant
Other Names:
  • Levonorgestrel subdermal implant (LNG-I)
ENG-I
Etonogestrel subdermal implant
Device: ENG-I
Etonogestrel subdermal implant
Other Names:
  • Etonogestrel subdermal implant (ENG-I)
Cu-IUD
Copper IUD
Device: Cu-IUD
Copper IUD
Other Names:
  • Copper IUD (Cu-IUD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genital tract CD4 cells (number and % expressing CCR5)
Time Frame: Change from baseline at 3 months
To quantify and characterize immune cell populations and HIV-tropic receptor expression in the genital tract and blood at baseline and after 1, 3 and 6 months of typical contraceptive use. Immune cell populations will be quantified and characterized using flow cytometry.
Change from baseline at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal microbiota (key microbes)
Time Frame: Change from baseline at 3 months
To describe the microflora of the genital tracts of healthy asymptomatic women before and after 1, 3 and 6 months of typical contraceptive use and to assess changes in the vaginal ecology within the first 6-months of contraceptive use. qPCR for key microflora and Nugent scores will be used.
Change from baseline at 3 months
Serum hemoglobin
Time Frame: Change from baseline at 6 months
To objectively assess blood count before and at 1,3,and 6 months following initiation of each contraceptive method. Standard clinical complete blood count (CBC) will be obtained at each visit.
Change from baseline at 6 months
Serum concentration of estradiol and progesterone/progestin
Time Frame: Change from baseline at 3 months
To assess relative serum concentrations of endogenous and exogenous sex hormones before and after contraceptive use. Hormonal concentrations will be assessed by measuring blood levels of estrogen and progesterone as well as blood levels of the contraceptive progestin corresponding to the cohort group for that participant.
Change from baseline at 3 months

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Collaborators

University of Zimbabwe

Investigators

  • Study Chair: Sharon Achilles, MD, PhD, University of Pittsburgh
  • Principal Investigator: Felix Mhlanga, MD, University of Zimbabwe, University of California San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

February 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (ESTIMATE)

January 16, 2014

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO13080550

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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