Emergency Department-based Cervical Cancer Screening Through Self-sampling

NCT ID: NCT07345897

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2028-01-31

Brief Summary

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

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

Cervical Cancer Screening

Intervention Type: DIAGNOSTIC_TEST

Subjects will perform self sampling for cervical cancer.

Interventions

Cervical Cancer Screening

Subjects will perform self sampling for cervical cancer.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Cisgender women and transgender/non-binary individuals with a cervix,

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Beau Abar

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Research Administrator

Role: CONTACT

peter_macdowell@urmc.rochester.edu

585-274-1509

Other Identifiers

00011046

Identifier Type: -

Identifier Source: org_study_id