Vaginal Washing Cessation Impact on Cervicovaginal Inflammation
Vaginal washing cessation
Blood-Borne Infections+17
+ Urogenital Diseases
+ Genital Diseases
Basic Science Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.122 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives