Advancing Cervical Cancer Screening Through Emergency Department-based Self-Sampling
| Registry | NCT07345897 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, screening |
| Enrollment | 200 (Estimated) |
| Sponsor | University of Rochester (Other) |
| Conditions | HPV, HPV Associated Cancers, HPV Cancers, Cervical Cancer Screening, Cervical Cancer (Early Detection) |
| Interventions | Cervical Cancer Screening (Diagnostic test) |
| Dates | start 2026-02-13, primary completion 2027-08-01 (estimated), completion 2028-01-01 (estimated), first posted 2026-01-16, last updated 2026-05-04 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for HPV All trials for HPV Associated Cancers All trials of Cervical Cancer Screening
This project will compare the uptake of cervical cancer screening through ED HPV sampling among patients presenting to the ED.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention Arm | Experimental | Diagnostic Test: Cervical Cancer Screening | 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. |
Sex: Female, ages: 30 Years to 65 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Rochester Strong Memorial Hospital | Rochester, New York | United States | Recruiting |