HPV Self-Collection Program
Part of paid clinical trials in Salt Lake City, Utah.
- Sponsor
- University of Utah
- Study ID
- NCT06674681
- Status
- Recruiting
Conditions
- HPV
Eligibility Criteria
- Sex
- FEMALE
- Age
- 25 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- HPV Self-Collection — DIAGNOSTIC_TESTHPV self-collection program for in-clinic and mailed cervical cancer screening.
Study Details
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.
Key Dates
- Start date
- Oct 18, 2024
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 1,000 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Other: HPV Self-CollectionPatients 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.
Primary Outcome Measure
Clinic Level Implementation Rate [ Time Frame: 1 year ]
Central Contacts
- Deanna Kepka801-587-4565
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences | Salt Lake City | Utah | 84112 | Stephen Gubler Deanna Kepka, PhD, MPH (PRINCIPAL_INVESTIGATOR) |
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