The Impact of Vaginal Washing on Cervical Inflammation
Recruiting · NCT06615232 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Washington
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- Pwani Research Center - Mombasa, Kenya