# The impact of vaginal washing on cervical inflammation: a randomized controlled trial of women from sub-Saharan Africa at high risk for HIV acquisition.

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2024 · $721,486

## Abstract

Project 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. Although it has been hypothesized that disruption of vaginal
microbiota may mediate the relationship between vaginal washing and HIV acquisition, results of studies
evaluating this relationship are mixed. In preliminary studies, we found associations between vaginal washing
and higher concentrations of IL-1 in cervicovaginal fluid and CD4+ T cells from cervical biopsy specimens.
These associations were independent of the presence of bacterial vaginosis (BV), leading us to hypothesize that
vaginal washing may increase HIV susceptibility by causing persistent activation of the IL-1 pathway, recruitment
of HIV-susceptible target cells, and disruption of the mucosal barrier. The primary objective of this proposal is
to test the hypothesis that a vaginal washing cessation intervention will lower concentrations of soluble
inflammatory mediators in cervicovaginal fluid, lower total immune cells in mucosal tissue, reduce cervical
epithelial disruption, and increase concentrations of protective vaginal Lactobacillus spp compared to control.
These biologic changes have the potential to reduce HIV susceptibility based on substantial evidence that
cervicovaginal inflammation, tissue breakdown, the absence of a Lactobacillus-dominated vaginal microbiota,
and the presence of suboptimal vaginal bacteria increase HIV susceptibility. To achieve this objective, we will
conduct a randomized controlled trial of vaginal washing cessation in a cohort of women who engage in sex work
in Mombasa, Kenya, and compare the following outcomes between participants randomized to the intervention
versus control arms of the study: i) concentrations of cervicovaginal cytokines, measured using a multiplex bead-
based immunoassay (Luminex platform); ii) concentrations of activated CD4+ T cells and antigen presenting
cells, measured from cervical biopsy specimens using flow cytometry; iii) expression of mucin and tight junction
proteins detected by immunofluorescent staining of fixed cervical biopsy tissue sections and quantified using
HALO image analysis software; iv) presence of cultivable Lactobacillus spp; and, v) concentrations of key
Lactobacillus spp measured using quantitative polymerase chain reaction. Together, these data will provide
mechanistic evidence for a causal link between vaginal washing and HIV acquisition risk and could be used to
support expansion of public health programs to reduce vaginal washing and lower HIV susceptibility among
populations at increased risk for HIV acquisition, such as women who engage in sex work. Furthermore, the
detailed evaluation of the cervicovaginal immune system and mucosa may provide valuable insight into the
mechanisms underlying other adverse reproducti...

## Key facts

- **NIH application ID:** 10922193
- **Project number:** 1R01HD115465-01
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Michelle Catherine Sabo
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $721,486
- **Award type:** 1
- **Project period:** 2024-09-16 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10922193

## Citation

> US National Institutes of Health, RePORTER application 10922193, The impact of vaginal washing on cervical inflammation: a randomized controlled trial of women from sub-Saharan Africa at high risk for HIV acquisition. (1R01HD115465-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10922193. Licensed CC0.

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