Emergency Department-based Cervical Cancer Screening Through Self-sampling

University of Rochester

Status: Begins enrollment this month

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

Treatments: Diagnostic Test: Cervical Cancer Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT07345897

00011046

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Cisgender women and transgender/non-binary individuals with a cervix,
• Age 30 - 65 years, and demonstrating decisional capacity to consent to participate with no known exclusion criteria present.

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Intervention Arm

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Cervical Cancer Screening