Vaginal Microbiota in HIV Infected Pregnant Women

Post Date: 
2017-07-14
Clinical Site(s): 
Country: 
Summary: 

Led by Dr. Rupak Shivakoti, this is a nested cross-sectional study of 30 HIV-infected and 60 non-HIV infected pregnant women. Pregnant women that are part of the parent study (“Impact of Immune Changes of HIV and Stages of Pregnancy on Tuberculosis” referred to as PRACHITI study from here on) will be enrolled from the antenatal clinic at Sassoon Hospital in Pune, India. They will be enrolled and have vaginal swab and urine samples collected at third trimester of their pregnancy.

The makeup of vaginal microbiota is dynamic and may play a role in the birth outcomes of pregnant women. While HIV and pregnancy both uniquely impact vaginal microbiota, the impact of HIV on vaginal microbiota of pregnant women has yet to be assessed. The purpose of this study is to characterize the vaginal microbiota of pregnant women in India and compare differences in vaginal microbiota of pregnant women based on HIV status.

Primary Objectives

  • Establish CSTs for pregnant women in Pune, India and compare them to those in the US (using published datasets)
  • Compare vaginal microbiota makeup of HIV-infected and uninfected pregnant women

     
Secondary Objectives

  • Determine the relationship between CD4+ count and the structure of the vaginal microbiota in HIV-infected pregnant women
  • Assess the prevalence of Sexually Transmitted Infections (STIs) (Gonorrhea, Chlamydia, Syphilis, Trichomonas, M. genitalium, Herpes simplex virus (HSV), Cytomegalovirus (CMV), Bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and helminths in pregnant women in Pune, India, stratified by HIV status. Please Note: CMV, syphilis and helminth will actually be tested in all 450 women from the parent PRACHITI study using stool and plasma/serum samples already collected and stored by the parent study.
  • Compare vaginal inflammatory cytokine levels in HIV-infected and uninfected pregnant women
  • Compare vaginal metabolome between HIV-infected and uninfected pregnant women
Collaborators: 
  • University of Maryland School of Medicine. Batimore, MD
  • Weill Cornell Medical College