Advancing Cervical Cancer Screening Through the Emergency Department - IIS

N/AActive Not RecruitingNCT06796738

University of Rochester200 enrolled

Overview

Cervical cancer screening in the Emergency Department

This will be an effort to deploy HPV self-sampling among Emergency Department patients. Emergency Department patients, in the US and worldwide, are disproportionally under-screened for cervical cancer relative to the general population.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Cervical Cancers HPV

Interventions

HPV testingDIAGNOSTIC_TEST

This study will use the Roche Cobas® 8800 system for HPV testing. The Roche Cobas HPV test is a PCR test that detects 14 hrHPV types and specifically identifies types 16 and 18.

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Cisgender women and transgender/non-binary individuals with a cervix, * Age 25-65, * Able to demonstrate decisional capacity to participate. Exclusion Criteria: * Past hysterectomy with cervical removal, * Known infection with HIV (as screening recommendations for people with HIV differ from the general population), * Non-English speaking.

Locations (1)

University of Rochester

Rochester, New York, United States

Outcomes

Primary Outcomes

Uptake of Cervical Cancer Screening

All intervention participants will receive a follow-up call at 150 days to assess uptake of any cervical cancer screening and for completion of the cervical cancer screening process. "Any cervical cancer screening" is defined as uptake of any aspect of the cervical cancer screening process, including self-sampling and/or clinic-based screening. "Completion of the cervical cancer screening process" is defined as completion of recommended clinic-based screening (including colposcopy if HPV 16/18+ or indicated).

Time frame: 150 days post initial intervention

Data from ClinicalTrials.gov

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