NCT02038335: Zim CHIC

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

Completed Last updated 1 December 2020

What this trial tests

trial testing DMPA in Contraception in 451 participants. Completed in 1 December 2020.

Timeline

1 February 2014

Primary endpoint
1 June 2016

1 December 2020

Quick facts

Lead sponsor	University of Pittsburgh
Status	Completed
Study type	OBSERVATIONAL
Enrollment	451
Start date	1 February 2014
Primary completion	1 June 2016
Estimated completion	1 December 2020
Sites	1 location across Zimbabwe

Drugs / interventions tested

• DMPA — full drug profile →
• NET-EN — full drug profile →
• MPA/E2 — full drug profile →
• LNG-I
• ENG-I
• Cu-IUD

Conditions studied

• Contraception — all drugs for Contraception →
• HIV — all drugs for HIV →
• Immune Cells (Mucosal and Systemic) — all drugs for Immune Cells (Mucosal and Systemic) →
• Microbiota — all drugs for Microbiota →

Sponsor

University of Pittsburgh

Who can join

Adults 18 to 34, female only, with Contraception or HIV. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of contraceptive initiation on vaginal microbiota.
   Achilles SL, Austin MN, Meyn LA, Mhlanga F, et al · · 2018 · cited 95× · PMID 29505773 · DOI 10.1016/j.ajog.2018.02.017
2. Misreporting of contraceptive hormone use in clinical research participants.
   Achilles SL, Mhlanga FG, Musara P, Poloyac SM, et al · · 2018 · cited 32× · PMID 28966052 · DOI 10.1016/j.contraception.2017.09.013
3. A sensitive and robust UPLC-MS/MS method for quantitation of estrogens and progestogens in human serum.
   Zhang J, Tang C, Oberly PJ, Minnigh MB, et al · · 2019 · cited 16× · PMID 30685285 · DOI 10.1016/j.contraception.2018.12.010
4. Zim CHIC: A cohort study of immune changes in the female genital tract associated with initiation and use of contraceptives.
   Achilles SL, Meyn LA, Mhlanga FG, Matubu AT, et al · · 2020 · cited 15× · PMID 32533883 · DOI 10.1111/aji.13287
5. Levonorgestrel in contraceptives and multipurpose prevention technologies: does this progestin increase HIV risk or interact with antiretrovirals?
   Polis CB, Phillips SJ, Hillier SL, Achilles SL. · · 2016 · cited 14× · PMID 27525548 · DOI 10.1097/qad.0000000000001229
6. Depot medroxyprogesterone acetate and norethisterone enanthate differentially impact T-cell responses and expression of immunosuppressive markers.
   Matubu A, Hillier SL, Meyn LA, Stoner KA, et al · · 2020 · cited 4× · PMID 31729087 · DOI 10.1111/aji.13210