An interventional study of Swab kit (COBAS HPV 4800 Assay -Evalyn brush) and Clinician-collection of cervical sample for HPV testing in Human Papilloma Virus, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Screening
The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Researchers will compare the laboratory results of self-collected vaginal swab samples to usual healthcare provider-collected cervical swab samples to determine the laboratory HPV testing accuracy of the self-collection swab.
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(Vaginal contraceptives, condoms and water-based lubricants can be used as normal.)
Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab
Diagnostic Test: Swab kit (COBAS HPV 4800 Assay -Evalyn brush) · Diagnostic Test: Clinician-collection of cervical sample for HPV testing
Patient self-sampling swab kit to collect a vaginal sample for HPV testing
Speculum exam and collection of a cervical specimen using standard endocervical brush and spatula placed into ThinPrep medium for HPV testing (Evalyn brush)
Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection
Patient-collected vaginal swab HPV results compared with gold standard of clinician-collected cervical swab) to accurately detect HPV infection
Time frame: Baseline (sample was collected up to 21 days form the date of registration)
Patient-reported Acceptability of Using the Evalyn Brush
Assessed by survey question "Overall, how acceptable was it for you to collect the sample using the Evalyn® brush?," which was answered on a 4-point scale (completely unacceptable, unacceptable, acceptable, or completely acceptable).
Time frame: Baseline (sample was collected up to 21 days form the date of registration)
Group 1: eligible participants enrolled = 89 (98 participants initially deemed eligible; 9 participants declined to participate) Group 2: eligible participants enrolled = 133 (207 participants initially deemed eligible; 74 declined to participate)
| Milestone | Group 1: Self-collected Vaginal Swab Samples at Clinic | Group 2: Self-collected Vaginal Swab Samples at Home |
|---|---|---|
| Started | 89 | 133 |
| Completed | 79 | 115 |
| Not completed | 10 | 18 |
| Withdrew: Withdrawal by subject | 3 | 8 |
| Withdrew: Invalid vaginal swab | 2 | 2 |
| Withdrew: Missing clinician collection | 3 | 6 |
| Withdrew: Screen failure | 1 | 2 |
| Withdrew: Sample lost in transit | 1 | 0 |
Patient-collected vaginal swab HPV results compared with gold standard of clinician-collected cervical swab) to accurately detect HPV infection
| Total Percentage Agreement | Group 1: Self-collected Vaginal Swab Samples at Clinic | Group 2: Self-collected Vaginal Swab Samples at Home |
|---|---|---|
| HPV16 | 98 | 94 |
| HPV18 | 99 | 95 |
| Other HPV | 86 | 89 |
Assessed by survey question "Overall, how acceptable was it for you to collect the sample using the Evalyn® brush?," which was answered on a 4-point scale (completely unacceptable, unacceptable, acceptable, or completely acceptable).
| Participants | Group 1: Self-collected Vaginal Swab Samples at Clinic | Group 2: Self-collected Vaginal Swab Samples at Home |
|---|---|---|
| Completely unacceptable | 0 | 0 |
| Unacceptable | 0 | 1 |
| Acceptable | 15 | 37 |
| Completely acceptable | 66 | 88 |
Collected over Baseline (at the time of swab collection). Participants collected swab samples up to 21 days from the time of enrollment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: Self-collected Vaginal Swab Samples at Clinic | 0/81 (0%) | 0/81 (0%) | 2/81 (2.5%) |
| Group 2: Self-collected Vaginal Swab Samples at Home | 0/127 (0%) | 0/127 (0%) | 1/127 (0.8%) |
| Event | Group 1: Self-collected Vaginal Swab Samples at Clinic | Group 2: Self-collected Vaginal Swab Samples at Home |
|---|---|---|
| Participant inserted self-collection device with cap on (did not remove cap)Product Issues | 2/81 | 0/127 |
| Device damaged during mailing to patientProduct Issues | 0/81 | 1/127 |
| Age, Categorical(Participants) | Group 1: Self-collected Vaginal Swab Samples at Clinic | Group 2: Self-collected Vaginal Swab Samples at Home | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 81 | 127 | 208 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Group 1: Self-collected Vaginal Swab Samples at Clinic | Group 2: Self-collected Vaginal Swab Samples at Home | Total |
|---|---|---|---|
| Female | 81 | 127 | 208 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: Self-collected Vaginal Swab Samples at Clinic | Group 2: Self-collected Vaginal Swab Samples at Home | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 5 | 9 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 77 | 122 | 199 |
| Race (NIH/OMB)(Participants) | Group 1: Self-collected Vaginal Swab Samples at Clinic | Group 2: Self-collected Vaginal Swab Samples at Home | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 0 | 3 | 3 |
| White | 72 | 114 | 186 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 9 | 7 | 16 |
| Region of Enrollment(participants) | Group 1: Self-collected Vaginal Swab Samples at Clinic | Group 2: Self-collected Vaginal Swab Samples at Home | Total |
|---|---|---|---|
| United States | 81 | 127 | 0 |
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