CClinicalTrials.gg
Active, not recruitingNCT06796738Updated Jan 16, 2026

Advancing Cervical Cancer Screening Through the Emergency Department - IIS

An interventional study of HPV testing in Cervical Cancers and HPV, sponsored by University of Rochester. Active, not recruiting at 1 site in United States. Open to female participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by University of Rochester · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
25 Years to 65 Years
Sex
Female
01

Study summary

Cervical cancer screening in the Emergency Department

Read the detailed 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.

02

Conditions studied

  • Cervical Cancers
  • HPV

Keywords

  • HPV
  • Cervical Cancer
  • Cancer Screening
03

In context

Uterine Cervical Neoplasms

1,883 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 200 is above the median of 100 across 1,378 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Cisgender women and transgender/non-binary individuals with a cervix,
  • Age 25-65,
  • Able to demonstrate decisional capacity to participate.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Other
    Intervention Arm - testing

    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.

    Diagnostic Test: HPV testing

Interventions

  • Diagnostic testHPV testing

    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.

06

What researchers measure

Primary outcomes

  1. Uptake of Cervical Cancer Screening

    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).

    Time frame: 150 days post initial intervention

07

Study locations

1 site
  • University of Rochester
    Rochester, New York 14642, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06796738
Lead sponsor
University of Rochester
Responsible party
David Adler (Professor, University of Rochester) — Principal investigator
First posted
Jan 28, 2025
Start date
Jun 13, 2025
Primary completion
Jan 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Jan 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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