Advancing Cervical Cancer Screening Through the Emergency Department - IIS

January 15, 2026 updated by: David Adler, University of Rochester

Advancing Cervical Cancer Screening Through the Emergency Department

Cervical cancer screening in the Emergency Department

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention Arm - testing
Participants in this arm will be provided the opportunity to self- sample for HPV during their ED visit. Participants will be (1) briefly instructed by the study staff on how to self-sample using a defined instructional script written at an elementary reading level, (2) provided with a packaged swab and vial of transport media, and (3) invited to self- sample privately in their ED room or in one of the private ED restrooms.
Diagnostic test: HPV testing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of Cervical Cancer Screening
Time Frame: 150 days post initial intervention
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).
150 days post initial intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

January 28, 2025

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Study 00010129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HPV

Clinical Trials on HPV testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe