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Recruiting

NCT Number: NCT07345897

Emergency Department-based Cervical Cancer Screening Through Self-sampling

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

Recruiting

Interested in participating?

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Key information

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cervical cancer screening

Diagnostic Test

Subjects will perform self sampling for cervical cancer.

Primary outcomes

  1. Uptake of cervical cancer screening from self-sampling in the ED

    Time frame: In about 150 days of enrollment

    Number of subjects referred for additional screening who follow through with next steps in the screening process.

Study contacts

Contact information is provided by the study sponsor or research team.

Research Administrator

CONTACT

[email protected]

585-274-1509

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 16, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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