HPV Self-Collection Program

NCT06674681 | Recruiting

• 2 other identifiers: HCI1694775R01CA279973-02
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Clinic Level Implementation Rate

  The proportion of people with a cervix who complete the test out of the number of people we were approached.

  1 year

Secondary Outcomes (2)

• At home utilization rate

  1 year

• Follow-up care rate

  1 year

Study Arms (1)

HPV Self-Collection

OTHER

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.

Diagnostic Test: HPV Self-Collection

Interventions

HPV Self-Collection DIAGNOSTIC_TEST

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

HPV Self-Collection

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Utah: lead

Study Sites (1)

University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences

Salt Lake City, Utah, 84112, United States

RECRUITING

Study Officials

• Deanna Kepka, PhD, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deanna Kepka

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 5, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)