NCT06615232 The Impact of Vaginal Washing on Cervical Inflammation
| NCT ID | NCT06615232 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Reproductive Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 122 participants |
| Start Date | 2025-05-16 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 122 participants in total. It began in 2025-05-16 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Michelle Sabo, Md, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06615232 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Reproductive Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06615232 currently recruiting?
Yes, NCT06615232 is actively recruiting participants. Contact the research team at sabo@uw.edu for enrollment information.
Where is the NCT06615232 trial being conducted?
This trial is being conducted at Mombasa, Kenya.
Who is sponsoring the NCT06615232 clinical trial?
NCT06615232 is sponsored by University of Washington. The principal investigator is Michelle Sabo, Md, PhD at University of Washington. The trial plans to enroll 122 participants.