Emergency Department-based Cervical Cancer Screening Through Self-sampling
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cervical Cancer Screening.
- Who it may be relevant to
- Registry conditions: HPV, HPV Associated Cancers, HPV Cancers, Cervical Cancer Screening. Basic parameters: 30 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Advancing Cervical Cancer Screening Through Emergency Department-based Self-Sampling
Overview
This project will compare the uptake of cervical cancer screening through ED HPV sampling among patients presenting to the ED.
Detailed description
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.
Interventions
- Diagnostic test Cervical Cancer Screening
Subjects will perform self sampling for cervical cancer.
Primary outcome measures
- Uptake of cervical cancer screening from self-sampling in the ED [Time frame: In about 150 days of enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- University of Rochester Strong Memorial Hospital — Rochester
Identifiers
NCT: NCT07345897 · 00011046