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Clinical Trial NCT06674681 for HPV is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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HPV Self-Collection Program 1,000 Home-Based Medical Device

Recruiting
Clinical Trial NCT06674681 is an interventional study for HPV that is recruiting. It started on October 18, 2024 with plans to enroll 1,000 participants. Led by University of Utah, it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on February 20, 2026.
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-...Show More
Detailed Description
There are 2 parts of this project; (i) the implementation of a self-collection program at clinics/FQHCs (which is a quality improvement project) and (ii) the study/research portion (which is implementation science).

(i) The investigators will develop protocols and educational materials for an HPV-self-collection program that is conducted in a healthcare setting and/or in patients' homes. These materials will inform ...

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Official Title

HPV Self-Collection Program

Conditions
HPV
Other Study IDs
NCT ID Number
NCT06674681
Start Date (Actual)
2024-10-18
Last Update Posted
2026-02-20
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
1,000
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Health Services Research
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherHPV 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.
HPV Self-Collection
HPV self-collection program for in-clinic and mailed cervical cancer screening.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
At home utilization rate
The number of people who completed the test at home compared to the number of people who completed the test in clinic.
1 year
Follow-up care rate
Among those with positive HVP test results, the number of people who complete recommended care.
1 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
25 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  • 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.

  • Individuals without a cervix.
  • Receiving hospice and/or palliative care during any part of the measurement period.
University of Utah logoUniversity of Utah304 active studies to explore
National Cancer Institute (NCI) logoNational Cancer Institute (NCI)3019 active studies to explore
Study Central Contact
Contact: Deanna Kepka, 801-587-4565, [email protected]
1 Study Locations in 1 Countries

Utah

University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences, Salt Lake City, Utah, 84112, United States
Stephen Gubler, Contact, [email protected]
Deanna Kepka, PhD, MPH, Principal Investigator
Recruiting