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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Human Papillomavirus-Related Cervical Carcinoma
• Intervention / Treatment: Other: Non-Interventional Study

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Caroline Chang; Phone Number: 904-953-4637; Email: Chang.Caroline@mayo.edu
• Study Contact Backup: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Mayo Clinic in Florida
      • Contact: Caroline Chang; Phone Number: 904-953-4637; Email: Chang.Caroline@mayo.edu
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Christopher C. DeStephano, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Female patients recruited after previous ED visits

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational aim 1 & aim 3; 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.	Other: Non-Interventional Study; Non-Interventional study
Observational aim 2; 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.	Other: Non-Interventional Study; Non-Interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human Papilloma Virus (HPV) sample self-collection following Emergency Department (ED) presentation	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.	Baseline
HPV vaccination following ED presentation	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.	One month
Interviews of women who decline self-collection	Phone or video-based interviews will be conducted with eligible participants who decline self-collection to determine reasons for non-participation.	Baseline
Interviews of women who consent to self-collection but do not complete the self-collection	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.	Up to 6 weeks
Interviews of women who complete the self-collection	Phone or video-based interviews will be conducted with participants who completed self-collection for feedback on the process.	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Christopher C. DeStephano, MD, MPH, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): September 16, 2026
• Primary Completion (Estimated): October 16, 2027
• Study Completion (Estimated): October 16, 2027

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: 23-009193 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2024-07532 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No