Reproductive BehaviorNCT06615232
The Impact of Vaginal Washing on Cervical Inflammation
A study testing Vaginal washing cessation in people with Reproductive Behavior, run by University of Washington at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Reproductive Behavior
- What is being tested?
- Vaginal washing cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteKenya
- Study dates
- 16 May 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Reports vaginal washing beyond the introitus in the past week
- Female, aged 18-50
- Presence of a cervix
- Informed consent obtained and form signed
- HIV-seronegative
- Non-pregnant (urine β-hCG negative)
- Willing to abstain from sex for 14 days after biopsy
- Post-menarche and pre-menopause
Who cannot join
- <3 months postpartum or current breastfeeding
- Current menstruation (can enroll after menses)
- History of bleeding disorder
- Visible cervical abnormality requiring evaluation
- Medical contraindication to study protocol
- Visible cervicovaginal ulcers or lesions
- Positive test for gonorrhea, chlamydia, trichomonas, or wet preparation and examination findings indicating vulvovaginal candidiasis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Pwani Research Center
Mombasa
Michelle C Sabo, MDPHD, 4408217962, sabo@uw.edu
Fatma Mwidadi, fmwidadi@uw.edu
About this study
Official title: The Impact of Vaginal Washing on Cervical Inflammation: A Randomized Controlled 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.
Read the 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.
- Conditions
- Reproductive Behavior
- Being tested
- Vaginal washing cessation
- Keywords
- sex work, hiv, vaginal washing, cervicovaginal inflammation, mucosal barrier disruption
- Medical subject headings
- Reproductive Behavior, Sex Work, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal washing cessationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal washing cessation (intervention) | Experimental | The intervention will consist of 3 small-group educational sessions focused on vaginal washing cessation. Receives: Behavioral: Vaginal washing cessation |
| Control | No intervention | Women in the control arm will return for weekly visits (to answer study questionnaires), but will not attend group educational sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)
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
Measured: Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)
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
Measured: Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)
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
Measured: 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
Concentrations of Lactobacillus spp. of interest will be measured by qPCR performed on DNA extracted from vaginal swabs collected at study visits
Measured: Collected at baseline (study enrollment, time zero), at the end of the intervention (study week 4) and 3 months after enrollment (study week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start16 May 2025
- Primary completionOct 2026 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive BehaviorStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women will be randomized in groups of 20 to either the vaginal washing cessation intervention or control (no intervention) arm. Women randomized to the intervention arm will attend 3 small group sessions over the course of a month focused on sexual health education and vaginal washing cessation. Women in both groups will be asked to provide samples (vaginal swabs, cervical swabs, cervicovaginal fluid, cervical biopsy specimens) at baseline and then at pre-specified timepoints after the intervention.
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Michelle Sabo, University of Washington
- Investigators
- Michelle Sabo, Md, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615232
- Sponsor's protocol ID
- STUDY00021251
- Other IDs
- R01HD115465
- Status last verified
- Apr 2026
- First submitted
- 23 Sep 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vaginal Washing on Cervical Inflammation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06615232
- Acronym / sponsor ID
- STUDY00021251
- Conditions
- Reproductive Behavior
- Keywords
- sex work, hiv, vaginal washing, cervicovaginal inflammation, mucosal barrier disruption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 16 May 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women will be randomized in groups of 20 to either the vaginal washing cessation intervention or control (no intervention) arm. Women randomized to the intervention arm will attend 3 small group sessions over the course of a month focused on sexual health education and vaginal washing cessation. Women in both groups will be asked to provide samples (vaginal swabs, cervical swabs, cervicovaginal fluid, cervical biopsy specimens) at baseline and then at pre-specified timepoints after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Vaginal washing cessation (intervention) | Experimental | Behavioral: Vaginal washing cessationThe intervention will consist of 3 small-group educational sessions focused on vaginal washing cessation. |
| Control | No intervention | –Women in the control arm will return for weekly visits (to answer study questionnaires), but will not attend group educational sessions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Reports vaginal washing beyond the introitus in the past week
- Female, aged 18-50
- Presence of a cervix
- Informed consent obtained and form signed
- HIV-seronegative
Key exclusion criteria (7 listed)
- <3 months postpartum or current breastfeeding
- Current menstruation (can enroll after menses)
- History of bleeding disorder
- Visible cervical abnormality requiring evaluation
- Medical contraindication to study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal washing cessationParticipants 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. | Behavioural | Vaginal washing cessation (intervention) |
Primary outcome
Concentrations of cervicovaginal cytokines
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.
Activated CD4+ T cells and antigen presenting cells per mg cervical biopsy tissue
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
Percent cells expressing mucin or tight junction proteins
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
Presence of cultivable Lactobacillus spp
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
Concentrations of Lactobacillus spp of interest
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Sabo, Md, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal washing cessation in people with Reproductive Behavior, run by University of Washington at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Sabo, MD, PhD (206-685-4456, sabo@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of cervicovaginal cytokines (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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.