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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Pittsburgh
Sponsor:
Collaborator:
University of Zimbabwe
Information provided by (Responsible Party):
Sharon Achilles, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02038335
First received: January 8, 2014
Last updated: January 31, 2014
Last verified: January 2014

January 8, 2014
January 31, 2014
January 2014
April 2015   (final data collection date for primary outcome measure)
Genital tract CD4 cells (number and % expressing CCR5) [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT02038335 on ClinicalTrials.gov Archive Site
  • Vaginal microbiota (key microbes) [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
    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.
  • Serum hemoglobin [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
    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.
  • Serum concentration of estradiol and progesterone/progestin [ Time Frame: Change from baseline at 3 months ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC
HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, plasma archive, vaginal swabs, serum, cervicovaginal lavage fluid

Non-Probability Sample

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

  • Contraception
  • HIV
  • Immune Cells (Mucosal and Systemic)
  • Microbiota
  • Drug: DMPA
    Depot medroxyprogesterone acetate
    Other Name: Depot medroxyprogesterone acetate (DMPA)
  • Drug: NET-EN
    Norethisterone enantate
    Other Name: Norethisterone enantate (NET-EN)
  • Drug: MPA/E2
    Medroxyprogesterone acetate and estradiol cypionate
    Other Name: Medroxyprogesterone acetate and estradiol cypionate (MPA/E2)
  • Device: LNG-I
    Levonorgestrel subdermal implant
    Other Name: Levonorgestrel subdermal implant (LNG-I)
  • Device: ENG-I
    Etonogestrel subdermal implant
    Other Name: Etonogestrel subdermal implant (ENG-I)
  • Device: Cu-IUD
    Copper IUD
    Other Name: Copper IUD (Cu-IUD)
  • DMPA
    Depot medroxyprogesterone acetate
    Intervention: Drug: DMPA
  • NET-EN
    Norethisterone enantate
    Intervention: Drug: NET-EN
  • MPA/E2
    Medroxyprogesterone acetate and estradiol cypionate
    Intervention: Drug: MPA/E2
  • LNG-I
    Levonorgestrel subdermal implant
    Intervention: Device: LNG-I
  • ENG-I
    Etonogestrel subdermal implant
    Intervention: Device: ENG-I
  • Cu-IUD
    Copper IUD
    Intervention: Device: Cu-IUD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
April 2016
April 2015   (final data collection date for primary outcome measure)

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
Female
18 Years to 34 Years
No
Contact: Sabrina Malik, MPH 412-641-8247 maliks2@upmc.edu
Zimbabwe
 
NCT02038335
PRO13080550
Yes
Sharon Achilles, University of Pittsburgh
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
University of Pittsburgh
January 2014

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