Advancing Cervical Cancer Screening Through the Emergency Department - IIS

University of Rochester

Status: Active, not recruiting

Conditions: HPV; Cervical Cancers

Treatments: Diagnostic Test: HPV testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06796738

Study 00010129

Details and patient eligibility

About

Cervical cancer screening in the Emergency Department

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Intervention Arm - testing

Other group

Description:

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.

Treatment:

Diagnostic Test: HPV testing