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The Impact of Vaginal Washing on Cervical Inflammation

NCT06615232 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Reproductive Behavior

Interventions

BEHAVIORAL

Vaginal washing cessation

Participants will attend weekly small group (\~10 women per group) sessions that are structured using the transtheoretical model of behavioral change to promote vaginal washing cessation.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Michelle Sabo, Md, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-16
Primary Completion
2026-10-31
Completion
2029-06-30

Countries

  • Kenya

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06615232 on ClinicalTrials.gov