Pwani Research Center
Mombasa, Kenya
Location status: Recruiting
NCT Number: NCT06615232
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.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
Mombasa, Kenya
Location status: Recruiting
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 This hypothesis is supported by preliminary findings (unpublished data) linking vaginal washing to increased concentrations of cervicovaginal IL-1 beta and a trend towards higher cervical concentrations of CD4+ T cells.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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)
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)
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)
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)
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)
Concentrations of Lactobacillus spp. of interest will be measured by qPCR performed on DNA extracted from vaginal swabs collected at study visits
Contact information is provided by the study sponsor or research team.
University of Washington
Other
The Impact of Vaginal Washing on Cervical Inflammation: A Randomized Controlled Trial
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