Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)

Primary Objectives

• To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").

Secondary Objectives

• To evaluate the results of the Rice HPV test with corresponding pathology results to assess the association of HPV test results with the presence of high-grade cervical dysplasia (CIN 2+).
• To assess how different sample processing methods affect the performance of the Rice HPV test.
• To assess how different test readout methods affect the performance of the Rice HPV test.

Exploratory Objectives

• Compare the performance of the Rice HPV test between provider-collected and self-collected samples.
• Conduct a survey on participant experiences with self-sampling to assess whether participants prefer self-sampling over provider-collected sampling.
• Compare the performance of the Rice HPV test to other benchmark HPV tests such as GeneXpert.

Inclusion criteria

• People with a cervix 21 years of age or older.
• Scheduled to undergo hrHPV testing at MD Anderson and The Harris Health System (LBJ Hospital) according to national and institutional guidelines at time of enrollment OR are anticipated to undergo a LEEP, ECC, or biopsy.
• Willing and able to provide informed consent.
• Able to perform protocol-required activities. Able to speak and read English or Spanish.

Exclusion criteria

• Patient or provider decision not to perform HPV testing. This does not apply to patients that are undergoing either a LEEP, ECC or biopsy.
• Participant or provider decision not to collect a sample for this study.
• Participants that are pregnant.