Actively Recruiting

Phase Not Applicable
Age: 25Years - 65Years
FEMALE
Healthy Volunteers
NCT06674681

HPV Self-Collection Program

Led by University of Utah · Updated on 2026-02-20

1000

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The objective of the study is to develop, pilot, and analyze the effectiveness of HPV self-collection programs which will be used to follow up among women overdue for cervical cancer screening. The investigators will develop protocols for in-clinic and home-based HPV-self-collection programs and follow-up system for HPV-positive tests for community health centers and/or clinics. The program is meant to mail HPV-self-collection kits to women who are due and/or overdue for cervical cancer screening and the program is also meant to present women seen in clinic with a self-collection option for screening alongside a Pap test option. The research team will develop related informational resources on how to complete the test as well as information on screening options. The study will neither experiment nor test the effectiveness of the self-collection process nor the assay of specimens for HPV and high-risk HPV strains. It is not a clinical investigation to assess the safety or effectiveness of a medical device. The study is implementation science and seeks to find optimal ways to implement this World Health Organization recommended screening option.

CONDITIONS

Official Title

HPV Self-Collection Program

Who Can Participate

Age: 25Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women and individuals with a cervix
  • Aged 25-65 years during the study measurement period
  • Had a qualifying visit to the participating clinic
  • Overdue for cervical cancer screening
  • Aged 24-64 with no cervical cytology (Pap test) in the last 3.5 years, or aged 30-65 with no cervical HPV testing in the last 5.5 years
Not Eligible

You will not qualify if you...

  • Individuals without a cervix
  • Receiving hospice and/or palliative care during any part of the measurement period

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

D

Deanna Kepka

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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