Emergency Department-based Cervical Cancer Screening Through Self-sampling

NCT07345897 | Recruiting

• 1 other identifier: 00011046
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

HPV Screening; Cervical cancer screening; HPV; Cervical cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  In about 150 days of enrollment

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Participants will be provided the opportunity to self- sample for HPV during their ED visit. Participants will be (1) briefly instructed by 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 (3) invited to self- sample privately in their ED room or in one of the private ED restrooms. Once self sampling has been completed, the study staff will then transfer the swab to a vial of transport media and forward the specimens to the laboratory for analysis. Participants recruited to the intervention arm that subsequently decline to or are unable to self-sample in the ED will remain in the study and will receive referral for clinic-based screening.

Diagnostic Test: Cervical Cancer Screening

Interventions

Cervical Cancer Screening DIAGNOSTIC_TEST

Subjects will perform self sampling for cervical cancer.

Intervention Arm

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• 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,

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)
• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Strong Memorial Hospital

Rochester, New York, 14642, United States

RECRUITING

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

Central Study Contacts

Research Administrator

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 16, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-01

Locations

US (1)