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

NCT ID: NCT06607874

Last Updated: 2025-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-16

Study Completion Date

2026-09-16

Brief Summary

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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

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Conditions

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Human Papillomavirus-Related Cervical Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Non-Interventional Study

Intervention Type 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.

Non-Interventional Study

Intervention Type OTHER

Non-Interventional study

Interventions

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Non-Interventional Study

Non-Interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher C. DeStephano, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Caroline Chang

Role: CONTACT

904-953-4637

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Caroline Chang

Role: backup

904-953-4637

Related Links

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Other Identifiers

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NCI-2024-07532

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-009193

Identifier Type: OTHER

Identifier Source: secondary_id

23-009193

Identifier Type: -

Identifier Source: org_study_id

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