NCT06674681 · University of Utah
HPV Self-Collection Program
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
HPV Self-Collection
HPV self-collection program for in-clinic and mailed cervical cancer screening.
Primary outcome measures
Clinic Level Implementation Rate
Time frame: 1 year
The proportion of people with a cervix who complete the test out of the number of people we were approached.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Salt Lake City, Utah
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2026 · Source of record for eligibility and locations