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

Not yet recruiting

• Conditions: Human Papillomavirus-Related Cervical Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06607874
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-19
• Last Update Submitted: 2024-09-19
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Study Start: 2024-10-16
• Primary Completion: 2025-09-16
• Study Completion: 2025-09-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational aim 1 & aim 3	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	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States