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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical Cancer Screening | Diagnostic Test | Subjects will perform self sampling for cervical cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of cervical cancer screening from self-sampling in the ED | Number of subjects referred for additional screening who follow through with next steps in the screening process. | In about 150 days of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Administrator | Contact | 585-274-1509 | peter_macdowell@urmc.rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Strong Memorial Hospital | Recruiting | Rochester | New York | 14642 | United States |
No decision has been made to share individual participant data however there is no current plan to share on an individual basis.
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |