Advancing Cervical Cancer Screening Through the Emergency Department - IIS

NCT06796738 | Active Not Recruiting FDA Device

• 1 other identifier: Study 00010129
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical cancer screening in the Emergency Department

Conditions

Cervical Cancers; HPV

Keywords

HPV; Cervical Cancer; Cancer Screening

Outcome Measures

Primary Outcomes (1)

• 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).

  150 days post initial intervention

Study Arms (1)

Intervention Arm - testing

OTHER

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

Interventions

HPV testing DIAGNOSTIC_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.

Intervention Arm - testing

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: Cisgender women and transgender/non-binary individuals with a cervix.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cisgender women and transgender/non-binary individuals with a cervix,
• Age 25-65,
• Able to demonstrate decisional capacity to participate.

You may not qualify if:

• Past hysterectomy with cervical removal,
• Known infection with HIV (as screening recommendations for people with HIV differ from the general population),
• Non-English speaking.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: June 13, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)