The Impact of Vaginal Washing on Cervical Inflammation
ConditionReproductive Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Reports vaginal washing beyond the introitus in the past week
Female, aged 18-50
Presence of a cervix
Informed consent obtained and form signed
Disqualifiers
<3 months postpartum or current breastfeeding
Current menstruation (can enroll after menses)
History of bleeding disorder
Visible cervical abnormality requiring evaluation
Trial design
Design model
Parallel
Treatments tested in this trial
Vaginal washing cessation
BehavioralParticipants 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.
Treatment groups
122 Participants
are divided into 2 treatment groupsGroup A: Vaginal washing cessation (intervention)Experimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)2
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
Time frame
Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)3
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
Time frame
Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)4
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
Time frame
Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Washington
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov