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

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. Identifier: NCT02038335
Recruitment Status : Active, not recruiting
First Posted : January 16, 2014
Last Update Posted : May 10, 2018
University of Zimbabwe
Information provided by (Responsible Party):
Sharon Achilles, University of Pittsburgh

Brief Summary:

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.

Condition or disease Intervention/treatment
Contraception HIV Immune Cells (Mucosal and Systemic) Microbiota Drug: DMPA Drug: NET-EN Drug: MPA/E2 Device: LNG-I Device: ENG-I Device: Cu-IUD

Study Type : Observational
Actual Enrollment : 451 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC
Actual Study Start Date : February 2014
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Depot medroxyprogesterone acetate
Drug: DMPA
Depot medroxyprogesterone acetate
Other Name: Depot medroxyprogesterone acetate (DMPA)

Norethisterone enantate
Drug: NET-EN
Norethisterone enantate
Other Name: Norethisterone enantate (NET-EN)

Medroxyprogesterone acetate and estradiol cypionate
Drug: MPA/E2
Medroxyprogesterone acetate and estradiol cypionate
Other Name: Medroxyprogesterone acetate and estradiol cypionate (MPA/E2)

Levonorgestrel subdermal implant
Device: LNG-I
Levonorgestrel subdermal implant
Other Name: Levonorgestrel subdermal implant (LNG-I)

Etonogestrel subdermal implant
Device: ENG-I
Etonogestrel subdermal implant
Other Name: Etonogestrel subdermal implant (ENG-I)

Copper IUD
Device: Cu-IUD
Copper IUD
Other Name: Copper IUD (Cu-IUD)

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Biospecimen Retention:   Samples With DNA
whole blood, plasma archive, vaginal swabs, serum, cervicovaginal lavage fluid

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy women, age 18-34 years, who are HIV negative and non-pregnant.

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

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 identifier (NCT number): NCT02038335

Harare, Zimbabwe
Sponsors and Collaborators
University of Pittsburgh
University of Zimbabwe
Study Chair: Sharon Achilles, MD, PhD University of Pittsburgh
Principal Investigator: Felix Mhlanga, MD University of Zimbabwe, University of California San Francisco

Responsible Party: Sharon Achilles, Principal Investigator and Protocol Chair, University of Pittsburgh Identifier: NCT02038335     History of Changes
Other Study ID Numbers: PRO13080550
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by Sharon Achilles, University of Pittsburgh:
immune cells
intrauterine device
subdermal implant

Additional relevant MeSH terms:
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Medroxyprogesterone Acetate
Norethindrone acetate
Norethindrone enanthate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Growth Substances
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents