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HPV Self-Collection Program

Who can join

Ages 25 to 65 · Women · Healthy volunteers welcome

Inclusion Criteria:

* Women and individuals with a cervix.
* Aged 25-65 years during the study measurement period.
* Qualifying visit to the participating clinic.
* Overdue for cervical cancer screening.
* Those aged 24-64 who have not had cervical cytology (i.e., Pap test) performed within the last three and a half (3.5) years, or those aged 30-65 who have not had cervical HPV testing (i.e., primary HPV testing or contesting for HPV with Pap test) performed within the last five and a half (5.5) years.

Exclusion Criteria:

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

About the study

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.

What is being tested

• HPV Self-Collection (diagnostic test)

Sponsor: University of Utah · Participants: 1,000 · Started: Oct 18, 2024

Contact the study team

• Deanna Kepka · Phone: 801-587-4565

Official record on ClinicalTrials.gov — NCT06674681

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.