Actively Recruiting
The Impact of Vaginal Washing on Cervical Inflammation
Led by University of Washington · Updated on 2026-05-05
122
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Vaginal washing is a common practice that many women perceive as hygienic. However, vaginal washing has been linked to adverse reproductive health outcomes including increased HIV acquisition risk. The mechanism linking vaginal washing to HIV risk remains unknown, but may be related to increased inflammation caused by intravaginal washing practices. The primary objective of this study is to test the hypothesis that a vaginal washing cessation intervention will reduce concentrations of soluble inflammatory mediators in cervicovaginal fluid and total immune cells in mucosal tissue, reduce cervical epithelial disruption, and increase concentrations of protective vaginal Lactobacillus spp. compared to control.
CONDITIONS
Official Title
The Impact of Vaginal Washing on Cervical Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 b2-hCG negative)
- Willing to abstain from sex for 14 days after biopsy
- Post-menarche and pre-menopause
You will not qualify if you...
- Less than 3 months postpartum or currently 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 vulvovaginal candidiasis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Pwani Research Center
Mombasa, Kenya
Actively Recruiting
Research Team
M
Michelle Sabo, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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