Actively Recruiting

Phase Not Applicable
Age: 30Years - 65Years
FEMALE
Healthy Volunteers
ID07345897

Advancing Cervical Cancer Screening Through Emergency Department-based Self-Sampling

Led by University of Rochester · Updated on 2026-05-04

200

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of self-sampling for cervical cancer screening in the emergency department (ED) among women and transgender/non-binary individuals with a cervix aged 30 to 65 years. This single-arm pilot trial aims to compare how many patients complete cervical cancer screening through HPV self-sampling during their ED visit, addressing barriers to care and participant experiences with this method. Follow-up will assess screening activity and related outcomes about 150 days after enrollment. Participants will be given instructions on how to self-sample for HPV using a swab during their ED visit. They can perform the sample collection privately, either in their ED room or a private restroom. After sampling, the swabs are sent to a laboratory for analysis. Those who choose not to or cannot complete self-sampling will still remain in the study and be referred for clinic-based screening. Participants who are already adherent to screening guidelines will have their participation ended after a screening survey. During the study, participants will complete a survey and follow-up at 150 days will gather information on cervical cancer screening activity, barriers to care, and experiences with the intervention. Researchers will review electronic health records to verify screening activities and clinical testing completion. The primary outcome is the uptake of cervical cancer screening through self-sampling in the ED, monitored approximately 150 days after enrollment.

CONDITIONS

Brief Title

Emergency Department-based Cervical Cancer Screening Through Self-sampling

Who Can Participate

Age: 30Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Cisgender women and transgender/non-binary individuals with a cervix
  • Age 30 to 65 years
  • Ability to consent to participate with decisional capacity
  • No known exclusion criteria present
Not Eligible

You will not qualify if you...

  • Past hysterectomy with removal of the cervix
  • Known HIV infection
  • Inability to consent (e.g., intoxicated, in distress, or lacking decisional capacity)
  • Current pregnancy or within three months postpartum
  • Use of vaginal ovules, creams, washes, contraceptives, or condoms within past 3 days
  • Sexual intercourse, transvaginal ultrasound, or gynecological exam within past 2 days

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during the emergency department visit

Surveillance

Duration - Approximately 150 days

Participants who complete self-sampling are observed to determine cervical cancer screening activity, barriers to care, and experiences with the intervention.

1 follow-up contact at about 150 days after enrollment

Trial Site Locations

Total: 1 location

1

University of Rochester Strong Memorial Hospital

Rochester, New York, United States, 14642

Actively Recruiting

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Research Team

R

Research Administrator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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