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NCT07345897NARecruitingAccepts Healthy Volunteers

Emergency Department-based Cervical Cancer Screening Through Self-sampling

University of Rochester

Start Date

2/13/2026

Completion Date

1/1/2028

Summary

This project will compare the uptake of cervical cancer screening through ED HPV sampling among patients presenting to the ED.

Detailed Description

This is a single-arm pilot trial with a prospectively enrolled sample. The participants who complete the screening survey and are determined to be adherent (n \~ 600) will be notified that they appear to be adherent with current screening guidelines, and their participation ends at this point. These participants will be considered screen failures for study purposes. Women and transgender/non-binary individuals with a cervix, aged 30-65, will be recruited from a high-volume urban ED. Follow-up will occur at 150 days to determine CC screening activity, perceived and concrete barriers to care, and participant experiences with the intervention. Electronic Health Record (EHR) review will be conducted to corroborate participants' reports of screening activities and assess completion of clinic-based testing and clinical endpoints.

Eligibility Criteria

Age Range: 30 years to 65 years

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

Interventions

DIAGNOSTIC_TEST

Cervical Cancer Screening

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Conditions

HPVHPV Associated CancersHPV CancersCervical Cancer ScreeningCervical Cancer (Early Detection)

Locations

University of Rochester Strong Memorial Hospital

Rochester, New York 14642

United States