Search / Trial NCT06615232

The Impact of Vaginal Washing on Cervical Inflammation

Launched by UNIVERSITY OF WASHINGTON · Sep 23, 2024

Trial Information

Current as of October 04, 2024

Not yet recruiting

Keywords

Sex Work Hiv Vaginal Washing Cervicovaginal Inflammation Mucosal Barrier Disruption

Description

Vaginal washing is a common practice that many women perceive as normal and hygienic. However, vaginal washing has been linked to adverse reproductive health outcomes. Vaginal washing has been associated with increased HIV acquisition risk in a long-term open cohort study of women who engage in sex work in Mombasa, Kenya (Mombasa Cohort). Subsequent observational studies and a large individual participant data meta-analysis have supported this observation. It has been hypothesized that the mechanism linking vaginal washing and HIV acquisition involves disruption of the vaginal microbiota. ...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • * Reports vaginal washing beyond the introitus in the past week
  • * Female, aged 18-50
  • * Presence of a cervix
  • * Informed consent obtained and form signed
  • * HIV-seronegative
  • * Non-pregnant (urine β-hCG negative)
  • * Willing to abstain from sex for 14 days after biopsy
  • * Post-menarche and pre-menopause
  • Exclusion Criteria:
  • * \<3 months postpartum or current breastfeeding
  • * Current menstruation (can enroll after menses)
  • * History of bleeding disorder
  • * Visible cervical abnormality requiring evaluation
  • * Medical contraindication to study protocol
  • * Visible cervicovaginal ulcers or lesions
  • * Positive test for gonorrhea, chlamydia, trichomonas, or wet preparation and examination findings indicating vulvovaginal candidiasis

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0