Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT06674681

Conditions

HPV

Eligibility Criteria

Sex: Female

Age: 25 - 65

Healthy Volunteers: Accepted

Interventions

HPV Self-Collection

Study Details

Brief summary:

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

HPV

Study ID

NCT06674681

Start date

Oct 18, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: HPV Self-Collection

Patients at partnering clinics who are enrolled in the clinics' HPV self-collection program(s). The requirements for being enrolled in the program are based off of the American Cancer Society's recommendation for cervical cancer screening.

Interventions

HPV Self-Collection

HPV self-collection program for in-clinic and mailed cervical cancer screening.

Primary outcome measure

  • Clinic Level Implementation Rate [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Deanna Kepka

801-587-4565Deanna.Kepka@hci.utah.edu

Locations

University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Stephen Gubler

stephen.gubler@hci.utah.edu

Principal Investigator:

Deanna Kepka, PhD, MPH

More Information

Sponsor

University of Utah

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-02-20.