Self-sampling HPV screening offered in the emergency department
Official title: Advancing Cervical Cancer Screening Through Emergency Department-based Self-Sampling
Run by University of Rochester · NCT07345897 · Data updated 2026-11-12
This project tests whether offering HPV self-sampling in the emergency department helps more people aged 30–65 with a cervix get screened for cervical cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 65 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Status | Recruiting |
| Started | February 13, 2026 |
| Main results expected | August 2027 |
| Study ends | January 2028 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT07345897 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 30–65 with a cervix (cisgender women and transgender/non-binary individuals) who present to the participating ED, can give informed consent, and are not already up-to-date with cervical cancer screening are the ideal candidates.
✕Probably not a fit
People without a cervix (including those with prior hysterectomy), those with HIV, current pregnancy, inability to consent, or recent vaginal product use or sexual activity that would invalidate self-sampling are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-arm pilot enrolls people aged 30–65 with a cervix presenting to a high-volume urban emergency department to offer HPV self-sampling for cervical cancer screening. Participants complete a screening survey; those already adherent with guidelines (about 600) are notified, considered screen failures, and do not proceed with sampling. Non-adherent participants are offered a self-administered HPV sample in the ED and followed for 150 days to document screening activity, barriers to care, and participant experiences. Electronic health record review will corroborate self-reported screening completion and capture any clinic-based testing or clinical endpoints.
Why it matters
Potential benefit: If successful, this approach could increase screening coverage by reaching people who do not access routine primary care and help detect precancerous HPV-related changes earlier.
How similar studies have gone: HPV self-sampling has increased screening uptake in community and outreach settings, but delivering self-sampling specifically in emergency departments is a relatively novel approach with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cisgender women and transgender/non-binary individuals with a cervix, * Age 30 - 65 years, and demonstrating decisional capacity to consent to participate with no known exclusion criteria present. Exclusion Criteria: * Past hysterectomy with cervical removal * Known infection with HIV (as screening recommendations for people with HIV differ from the general population) * Inability to consent (e.g., lacking decisional capacity, intoxicated, or in distress) * Current pregnancy or in the three months after giving birth * Use of vaginal ovules, creams or washes, vaginal contraceptives or condoms within past 3 days * Sexual intercourse or transvaginal ultrasound scans or gynecological examinations within past 2 days
Where it's running
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University of Rochester Strong Memorial Hospital
Rochester, New York, United States Recruiting
Study contacts
- Study coordinator: Research Administrator
- Email: peter_macdowell@urmc.rochester.edu
- Phone: 585-274-1509
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.