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Vaginal Washing Cessation Impact on Cervicovaginal Inflammation

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What is being tested

Vaginal washing cessation

Behavioral
Who is being recruted

Blood-Borne Infections+17

+ Urogenital Diseases

+ Genital Diseases

From 18 to 50 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorUniversity of Washington
Study ContactMichelle Sabo, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2025

Actual date on which the first participant was enrolled.

This study investigates how vaginal washing might be connected to an increased risk of HIV, particularly among women involved in sex work in Mombasa, Kenya. The practice of vaginal washing, while often seen as hygienic, could disrupt the natural balance of bacteria in the vagina and cause inflammation, potentially making it easier for HIV to infect. The study aims to understand if stopping vaginal washing can reduce these risks by looking at changes in inflammation and bacteria in the vagina and cervix. Participants in the study will be part of a randomized trial where some will receive guidance on how to stop vaginal washing using a behavioral change model. Researchers will measure the levels of inflammation and the types of bacteria present in the vagina before and after the intervention. By examining these factors, the study hopes to identify the biological changes that occur when vaginal washing is reduced, potentially leading to better health outcomes and lower HIV risk.

Official TitleThe Impact of Vaginal Washing on Cervical Inflammation: A Randomized Controlled Trial
NCT06615232
Principal SponsorUniversity of Washington
Study ContactMichelle Sabo, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

122 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeBehaviorCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsSex WorkRetroviridae InfectionsRNA Virus InfectionsSexual BehaviorSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsReproductive Behavior

Criteria

8 inclusion criteria required to participate
Reports vaginal washing beyond the introitus in the past week

Female, aged 18-50

Presence of a cervix

Informed consent obtained and form signed

Show More Criteria

7 exclusion criteria prevent from participating
3 months postpartum or current breastfeeding

Current menstruation (can enroll after menses)

History of bleeding disorder

Visible cervical abnormality requiring evaluation

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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