| NCT ID | NCT06674681 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | HPV |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-10-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2024-10-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Deanna Kepka, PhD, MPH
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT06674681 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 65 Years, studying HPV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06674681 currently recruiting?
Yes, NCT06674681 is actively recruiting participants. Contact the research team at Deanna.Kepka@hci.utah.edu for enrollment information.
Where is the NCT06674681 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT06674681 clinical trial?
NCT06674681 is sponsored by University of Utah. The principal investigator is Deanna Kepka, PhD, MPH at University of Utah. The trial plans to enroll 1,000 participants.