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The Impact of Vaginal Washing on Cervical Inflammation: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Kenya
Pwani Research Center
RECRUITING
Mombasa
Contact Information
Primary
Michelle Sabo, MD, PhD
sabo@uw.edu
206-685-4456
Time Frame
Start Date: 2025-05-16
Estimated Completion Date: 2029-06
Participants
Target number of participants: 122
Treatments
Experimental: Vaginal washing cessation (intervention)
The intervention will consist of 3 small-group educational sessions focused on vaginal washing cessation.
No_intervention: Control
Women in the control arm will return for weekly visits (to answer study questionnaires), but will not attend group educational sessions.
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: University of Washington

This content was sourced from clinicaltrials.gov