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
  Purpose

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 Intervention
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
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 300
Study Start Date: January 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
DMPA
Depot medroxyprogesterone acetate
Drug: DMPA
Depot medroxyprogesterone acetate
Other Name: Depot medroxyprogesterone acetate (DMPA)
NET-EN
Norethisterone enantate
Drug: NET-EN
Norethisterone enantate
Other Name: Norethisterone enantate (NET-EN)
MPA/E2
Medroxyprogesterone acetate and estradiol cypionate
Drug: MPA/E2
Medroxyprogesterone acetate and estradiol cypionate
Other Name: Medroxyprogesterone acetate and estradiol cypionate (MPA/E2)
LNG-I
Levonorgestrel subdermal implant
Device: LNG-I
Levonorgestrel subdermal implant
Other Name: Levonorgestrel subdermal implant (LNG-I)
ENG-I
Etonogestrel subdermal implant
Device: ENG-I
Etonogestrel subdermal implant
Other Name: Etonogestrel subdermal implant (ENG-I)
Cu-IUD
Copper IUD
Device: Cu-IUD
Copper IUD
Other Name: Copper IUD (Cu-IUD)

  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders 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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038335

Contacts
Contact: Sabrina Malik, MPH 412-641-8247 maliks2@upmc.edu

Locations
Zimbabwe
UZ UCSF Recruiting
Harare, Zimbabwe
Contact: Felix Mhlanga, MD    263 4 704890    fmhlanga@uz-ucsf.co.zw   
Principal Investigator: Felix Mhlanga, MD         
Sponsors and Collaborators
University of Pittsburgh
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
  More Information

No publications provided

Responsible Party: Sharon Achilles, Principal Investigator and Protocol Chair, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02038335     History of Changes
Other Study ID Numbers: PRO13080550
Study First Received: January 8, 2014
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
contraception
immune cells
intrauterine device
IUD
copper
microbiota
DMPA
etonogestrel
subdermal implant
NET-EN
Jadelle
Implanon
Cyclofem

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

ClinicalTrials.gov processed this record on July 20, 2014