About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Individuals without a cervix.
Receiving hospice and/or palliative care during any part of the measurement period.
Trial design
Single group
Treatments tested in this trial
HPV Self-Collection
Diagnostic testHPV self-collection program for in-clinic and mailed cervical cancer screening.
Treatment groups
Trial outcomes
Primary outcomes
Clinic Level Implementation Rate
The proportion of people with a cervix who complete the test out of the number of people we were approached.
Secondary outcomes
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.
Follow-up care rate
Among those with positive HVP test results, the number of people who complete recommended care.
Sponsors and contacts
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University of Utah
Lead sponsor
National Cancer Institute (NCI)
Collaborator