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OpenTrials
Active, Not Recruiting

NCT Number: NCT06796738

Advancing Cervical Cancer Screening Through the Emergency Department - IIS

Cervical cancer screening in the Emergency Department

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cervical Cancers Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

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 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.

Treatment and study plan

HPV testing

Diagnostic Test

This study will use the Roche Cobas® 8800 system for HPV testing. The Roche Cobas HPV test is a PCR test that detects 14 hrHPV types and specifically identifies types 16 and 18.

Primary outcomes

  1. Uptake of Cervical Cancer Screening

    Time frame: 150 days post initial intervention

    All intervention participants will receive a follow-up call at 150 days to assess uptake of any cervical cancer screening and for completion of the cervical cancer screening process. "Any cervical cancer screening" is defined as uptake of any aspect of the cervical cancer screening process, including self-sampling and/or clinic-based screening. "Completion of the cervical cancer screening process" is defined as completion of recommended clinic-based screening (including colposcopy if HPV 16/18+ or indicated).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Advancing Cervical Cancer Screening Through the Emergency Department

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2025
Registry last updated
Jan 16, 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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