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NCT Number: NCT06607874

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

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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Key information

Conditions

Human Papillomavirus-Related Cervical Carcinoma

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-Interventional study

Primary outcomes

  1. Human Papilloma Virus (HPV) sample self-collection following Emergency Department (ED) presentation

    Time frame: 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.

  2. HPV vaccination following ED presentation

    Time frame: 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.

  3. Interviews of women who decline self-collection

    Time frame: Baseline

    Phone or video-based interviews will be conducted with eligible participants who decline self-collection to determine reasons for non-participation.

  4. Interviews of women who consent to self-collection but do not complete the self-collection

    Time frame: 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.

  5. Interviews of women who complete the self-collection

    Time frame: Up to 6 weeks

    Phone or video-based interviews will be conducted with participants who completed self-collection for feedback on the process.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Chang

CONTACT

[email protected]

904-953-4637

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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