Recruiting

Cervical Cancer Screening

Sponsor:

University of Rochester

Code:

NCT07345897

Conditions

HPV

HPV Associated Cancers

HPV Cancers

Cervical Cancer Screening

Cervical Cancer (Early Detection)

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Accepted

Interventions

Cervical Cancer Screening

Study Details

Brief summary:

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

Conditions

HPV

HPV Associated Cancers

HPV Cancers

Cervical Cancer Screening

Cervical Cancer (Early Detection)

Study ID

NCT07345897

Start date

Feb 13, 2026

Status verified date

Jan, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

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.

Interventions

Cervical Cancer Screening

Subjects will perform self sampling for cervical cancer.

Primary outcome measure

  • Uptake of cervical cancer screening from self-sampling in the ED [ Time Frame: In about 150 days of enrollment ]

Central Contacts and Locations

Central contacts

Research Administrator

585-274-1509peter_macdowell@urmc.rochester.edu

Locations

University of Rochester Strong Memorial Hospital

Recruiting

Rochester, New York, United States, 14642

Contacts

Beau Abar, PHD MS

5852758143beau_abar@urmc.rochester.edu

Peter MacDowell

5852741509peter_macdowell@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

May 4, 2026

Last verified

Jan, 2026

Keywords

  • HPV Screening
  • Cervical cancer screening
  • HPV
  • Cervical cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-05-04.