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

NCT06607874 | Not Yet Recruiting

• 2 other identifiers: 23-009193NCI-2024-07532
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Papillomavirus-Related Cervical Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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

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

Interventions

Non-Interventional Study OTHER

Non-Interventional study

Observational aim 1 & aim 3; Observational aim 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients recruited after previous ED visits

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Christopher C. DeStephano, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Caroline Chang

CONTACT

904-953-4637; Chang.Caroline@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start (Estimated): September 16, 2026
• Primary Completion (Estimated): October 16, 2027
• Study Completion (Estimated): October 16, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)