Self-Collection for Cervical Cancer Screening and HPV Vaccination for Cancer Prevention Among Women in Emergency Care in Northeast Florida

NCT06607874 — Not yet recruiting, 100 participants, Mayo Clinic

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Eligibility and Participation Characteristics of a Pilot Study of Self-Collection for Cervical Cancer Screening and HPV Vaccination for Cancer Prevention

Registry	NCT06607874
Status	Not yet recruiting
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Mayo Clinic (Other)
Conditions	Human Papillomavirus-Related Cervical Carcinoma
Interventions	Non-Interventional Study (Other)
Dates	start 2027-09-16 (estimated), primary completion 2028-10-16 (estimated), completion 2028-10-16 (estimated), first posted 2024-09-23, last updated 2026-08-05
Locations	1 site in United States

-Summary

Human Papilloma Virus (HPV) is a cause of cervical cancer in women. This study is being done to identify sites for cervical cancer screening and education regarding HPV vaccination outside of the traditional settings of primary care and gynecologic clinics. Identifying non-traditional cancer screening settings may increase cancer screening completion and HPV vaccination among women with limited health care knowledge and access who are vulnerable to health disparities.

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+Arms and interventions

Arm	Type	Interventions	Description
Observational aim 1 & aim 3		Other: Non-Interventional Study	Patients may choose to undergo HPV vaginal swab self-collection on study in the research clinic or at home. Patients may choose to complete an interview on study. In addition, patients have their medical records reviewed on study.
Observational aim 2		Other: Non-Interventional Study	Patients are contacted by the study Clinical Research Coordinator (CRC) by phone on study and informed of HPV vaccination eligibility, asked interest in being vaccinated, and informed of sites for HPV vaccination. Patients are then contacted again by the CRC to determine if HPV vaccination occurred.

Non-Interventional Study (Other): Non-Interventional study

+Outcome measures

Primary outcomes

Human Papilloma Virus (HPV) sample self-collection following Emergency Department (ED) presentation [Baseline]: Will be assessed by the percentage of women between 25-65 eligible for cervical cancer screening who participate or who opt not to participate in self-collection.
HPV vaccination following ED presentation [One month]: Will be assessed by the percentage of women between 18-26 eligible for HPV vaccination for cervical cancer prevention who participate in HPV vaccination. Participants will be contacted one month after initial contact to determine if the HPV vaccination was administered.
Interviews of women who decline self-collection [Baseline]: Phone or video-based interviews will be conducted with eligible participants who decline self-collection to determine reasons for non-participation.
Interviews of women who consent to self-collection but do not complete the self-collection [Up to 6 weeks]: Phone or video-based interviews will be conducted with participants who agree to participate but do not complete self-collection after 4 weeks to determine reasons for non-participation.
Interviews of women who complete the self-collection [Up to 6 weeks]: Phone or video-based interviews will be conducted with participants who completed self-collection for feedback on the process.

+Eligibility

Sex: Female, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* Adults assigned as female at birth age 18-65 with a Mayo Clinic medical record number

Exclusion Criteria:

* Adults assigned as female at birth age 0-17
* Adults assigned as female at birth age > 65
* Adults assigned as male at birth
* Adults assigned as female at birth without a Mayo Clinic medical record number

+Locations (1)

Facility	City	Country	Status
Mayo Clinic in Florida	Jacksonville, Florida	United States

+Investigators

Christopher C. DeStephano, MD, MPH, Principal investigator, Mayo Clinic