RecruitingInterventional

Advancing Cervical Cancer Screening Through Emergency Department-based Self-Sampling

NCT ID: NCT07345897Sponsor: University of RochesterLast updated: 2026-05-04

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.

Arms & interventions

Diagnostic TestCervical Cancer Screening
Subjects will perform self sampling for cervical cancer.

Outcome measures

Primary

Uptake of cervical cancer screening from self-sampling in the ED
Number of subjects referred for additional screening who follow through with next steps in the screening process.
Time frame: In about 150 days of enrollment

Eligibility criteria

Sex: FemaleAge: 30 Years to 65 YearsHealthy volunteers: Yes

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

Study locations (1)

University of Rochester Strong Memorial Hospital

Rochester, New York, 14642

Recruiting

Beau Abar, PHD MS · Contact

5852758143 beau_abar@urmc.rochester.edu

Peter MacDowell · Contact

5852741509 peter_macdowell@urmc.rochester.edu