HPV Self-Collection Program

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
United States
Utah
University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences
RECRUITING
Salt Lake City
Contact Information
Primary
Deanna Kepka
Deanna.Kepka@hci.utah.edu
801-587-4565
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 1000
Treatments
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.
Sponsors
Leads: University of Utah

This content was sourced from clinicaltrials.gov