Emergency Department-based Cervical Cancer Screening Through Self-sampling

N/ANot Yet RecruitingNCT07345897

University of Rochester200 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

200

Conditions

HPV HPV Associated Cancers HPV Cancers Cervical Cancer Screening Cervical Cancer (Early Detection)

Interventions

Cervical Cancer ScreeningDIAGNOSTIC_TEST

Subjects will perform self sampling for cervical cancer.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Central Contacts

Research Administrator

CONTACT

585-274-1509 peter_macdowell@urmc.rochester.edu

Data from ClinicalTrials.gov

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