Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615232
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
The Impact of Vaginal Washing on Cervical Inflammation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Vaginal Washing on Cervical Inflammation a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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of HIV target cells and disruption of the mucosal barrier This hypothesis is supported by preliminary findings unpublished data linking vaginal washing to increased concentrations of cervicovaginal IL-1 beta and a trend towards higher cervical concentrations of CD4 T cells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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None