Stopping vaginal washing to reduce cervical inflammation
Official title: The Impact of Vaginal Washing on Cervical Inflammation: A Randomized Controlled Trial
Run by University of Washington · NCT06615232 · Data updated 2026-11-12
This study will try stopping intravaginal washing to see if it lowers cervicovaginal inflammation, reduces immune cells that HIV can target, and restores protective Lactobacillus bacteria in HIV-negative women who report washing inside the vagina.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 122 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Mombasa) |
| Status | Recruiting |
| Started | May 16, 2025 |
| Main results expected | October 2026 |
| Study ends | June 2029 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT06615232 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are HIV-negative, non-pregnant women aged 18–50 with a cervix who report vaginal washing beyond the introitus within the past week and who can provide informed consent and comply with biopsy and follow-up requirements.
✕Probably not a fit
Women who are HIV-positive, currently pregnant or breastfeeding, under 18 or over 50, do not practice intravaginal washing, have active STIs or visible cervical lesions, or cannot abstain from sex for the required biopsy recovery period are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial enrolls HIV-negative, non-pregnant women aged 18–50 who report intravaginal washing and offers a behavioral intervention to stop that practice, with participants compared to a control group. Researchers will measure soluble inflammatory mediators in cervicovaginal fluid, quantify total immune cells in mucosal tissue, assess cervical epithelial disruption, and profile vaginal bacteria including Lactobacillus spp. Specimens include fluid sampling and mucosal biopsies with a required 14-day post-biopsy sexual abstinence period. The intervention is grounded in the transtheoretical model of behavior change and builds on a prior pilot of washing-cessation counseling.
Why it matters
Potential benefit: If successful, stopping intravaginal washing could reduce cervical inflammation and mucosal disruption and increase protective Lactobacillus, which may lower biological susceptibility to HIV and other reproductive harms.
How similar studies have gone: Observational studies have linked vaginal washing to adverse reproductive outcomes and some small pilots have tried behavior-change cessation, but direct interventional evidence showing that stopping washing reduces mucosal inflammation remains limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Pwani Research Center
Mombasa, Kenya Recruiting
Study contacts
- Principal investigator: Michelle Sabo, Md, PhD — University of Washington
- Study coordinator: Michelle Sabo, MD, PhD
- Email: sabo@uw.edu
- Phone: 206-685-4456
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.