The Impact of Vaginal Washing on Cervical Inflammation

NCT ID: NCT06615232

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2029-06-30

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.

Detailed Description

Vaginal washing is a common practice that many women perceive as normal and hygienic. However, vaginal washing has been linked to adverse reproductive health outcomes. Vaginal washing has been associated with increased HIV acquisition risk in a long-term open cohort study of women who engage in sex work in Mombasa, Kenya (Mombasa Cohort). Subsequent observational studies and a large individual participant data meta-analysis have supported this observation.

It has been hypothesized that the mechanism linking vaginal washing and HIV acquisition involves disruption of the vaginal microbiota. However, while some studies have demonstrated an association between vaginal washing and vaginal microbial disruption, others have not, suggesting that there may be other mechanisms linking vaginal washing and HIV acquisition risk. For example, vaginal washing could directly impact cervicovaginal inflammation, resulting in recruitment of HIV target cells and disruption of the mucosal barrier. This hypothesis is supported by preliminary findings (unpublished data) linking vaginal washing to increased concentrations of cervicovaginal IL-1 beta and a trend towards higher cervical concentrations of CD4+ T cells.

Despite the potential harms of the practice, cultural and behavioral norms may make cessation of vaginal washing difficult. To address this challenge, a pilot intervention grounded in the transtheoretical model of behavioral change for reducing vaginal washing was conducted among women in the Mombasa Cohort. After one month, all participants reported a reduction or cessation in vaginal washing practices, and at 6-12 months, 52% of women reported continued abstinence from vaginal washing. While the study was not powered to examine differences in biological outcomes related to vaginal washing, women who reduced vaginal washing during the study were observed to have fewer mucosal lesions by colposcopy, higher prevalences of cultivable Lactobacillus species (spp.), and lower concentrations of several cervicovaginal pro-inflammatory cytokines.

The primary objective of the present study is to identify the likely mechanisms linking vaginal washing and HIV acquisition risk. To achieve this objective, the investigators will conduct a randomized controlled trial of a vaginal washing cessation intervention (based in the transtheoretical model of behavioral change) to determine if a reduction in vaginal washing leads to improved mucosal homeostasis and decreased cervicovaginal inflammation by measuring i) cervicovaginal cytokine concentrations; ii) cervical immune cells from biopsy specimens; iii) expression of mucins and epithelial tight junction proteins from cervical biopsy specimens; iv) the presence of cultivable vaginal Lactobacillus spp; and, v) concentrations of select vaginal Lactobacillus spp.

Conditions

Reproductive Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Vaginal washing cessation (intervention)

The intervention will consist of 3 small-group educational sessions focused on vaginal washing cessation.

Group Type: EXPERIMENTAL

Vaginal washing cessation

Intervention Type: BEHAVIORAL

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.

Control

Women in the control arm will return for weekly visits (to answer study questionnaires), but will not attend group educational sessions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Michelle Sabo

Acting Assistant Professor: School of Medicine, Allergy and Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Sabo, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Central Contacts

Michelle Sabo, MD, PhD

Role: CONTACT

sabo@uw.edu

206-685-4456

Other Identifiers

R01HD115465

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00021251

Identifier Type: -

Identifier Source: org_study_id