The Impact of Vaginal Washing on Cervical Inflammation

NCT06615232 | Recruiting

• 2 other identifiers: STUDY00021251R01HD115465
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Reproductive Behavior

Keywords

sex work; hiv; vaginal washing; cervicovaginal inflammation; mucosal barrier disruption

Outcome Measures

Primary Outcomes (5)

• Concentrations of cervicovaginal cytokines

  Cervicovaginal cytokines will be measured from cervicovaginal fluid (collected via Softcup insertion for 15 minutes) using the Luminex platform, which is a multiplex bead-based immunoassay.

  Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)

• Activated CD4+ T cells and antigen presenting cells per mg cervical biopsy tissue

  Digested cervical biopsy specimens will be stained and analyzed to detect immune cells of interest using flow cytometry

  Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)

• Percent cells expressing mucin or tight junction proteins

  Expression of mucin and tight junction proteins will be detected by immunofluorescent staining of fixed cervical biopsy tissue sections and quantified

  Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)

• Presence of cultivable Lactobacillus spp

  Rogosa and Columbia blood agars will be inoculated with vaginal swabs collected at study visits and the number of women with cultivable species quantified

  Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)

• Concentrations of Lactobacillus spp of interest

  Concentrations of Lactobacillus spp. of interest will be measured by qPCR performed on DNA extracted from vaginal swabs collected at study visits

  Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)

Study Arms (2)

Vaginal washing cessation (intervention)

EXPERIMENTAL

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

Behavioral: Vaginal washing cessation

Control

NO INTERVENTION

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

Interventions

Vaginal washing cessation 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.

Vaginal washing cessation (intervention)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Pwani Research Center

Mombasa, Kenya

RECRUITING

MeSH Terms

Conditions

Reproductive Behavior; Sex Work; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Behavior; Sexual Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Michelle Sabo, Md, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Sabo, MD, PhD

CONTACT

206-685-4456; sabo@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor: School of Medicine, Allergy and Infectious Diseases

Model Details: Women will be randomized in groups of 20 to either the vaginal washing cessation intervention or control (no intervention) arm. Women randomized to the intervention arm will attend 3 small group sessions over the course of a month focused on sexual health education and vaginal washing cessation. Women in both groups will be asked to provide samples (vaginal swabs, cervical swabs, cervicovaginal fluid, cervical biopsy specimens) at baseline and then at pre-specified timepoints after the intervention.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: May 16, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

KE (1)