Cervical Cancers, HPV
Conditions
Keywords
HPV, Cervical Cancer, Cancer Screening
Brief summary
Cervical cancer screening in the Emergency Department
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.
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.
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
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
* Past hysterectomy with cervical removal, * Known infection with HIV (as screening recommendations for people with HIV differ from the general population), * Non-English speaking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of Cervical Cancer Screening | 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). |
Countries
United States
Outcome results
None listed