HPV Self-Collection Program

Not Applicable

Not yet recruiting

• Conditions: HPV

• Registration Number: NCT06674681
• Lead Sponsor: University of Utah

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 ce...

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).
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-10-29
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05
• Study Start: 2024-11-30
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1000

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinic Level Implementation Rate	1 year	The proportion of people with a cervix who complete the test out of the number of people we were approached.

Secondary Outcome Measures

Name	Time	Method
At home utilization rate	1 year	The number of people who completed the test at home compared to the number of people who completed the test in clinic.
Follow-up care rate	1 year	Among those with positive HVP test results, the number of people who complete recommended care.

Trial Locations

Locations (1)

University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences; 🇺🇸 Salt Lake City, Utah, United States