Human Papilloma Virus
Conditions
Keywords
Cervical Cancer Screening
Brief summary
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.
Interventions
DIAGNOSTIC_TESTSwab kit (COBAS HPV 4800 Assay -Evalyn brush)
Patient self-sampling swab kit to collect a vaginal sample for HPV testing
DIAGNOSTIC_TESTClinician-collection of cervical 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)
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Appointment at Mayo Clinic Rochester in Gynecology Colposcopy Clinic or ICS (integrated community specialty) Colposcopy Clinic (will always include a speculum exam). * Appointment at Mayo Clinic Rochester in Gynecology Clinic for indication that will already include a speculum exam (e.g., cervical cancer screening or IUD insertion).
Exclusion criteria
* Excluded if self-reported as currently menstruating, pregnant, or within 3 months following pregnancy. * Excluded if no cervix (history of total hysterectomy). * Excluded if moderate to heavy vaginal bleeding on the day of the visit. * Excluded if reason for visit in Gynecology Clinic is abnormal vaginal discharge. * Exclude patients who are on Gynecology Colposcopy Clinic for LEEP (loop electrosurgical excision procedure). * Exclude if any use of over-the-counter or prescription vaginal cream for vaginal infection or prescription vaginal estrogen cream for at least two days before using the Evalyn Brush. (Vaginal contraceptives, condoms and water-based lubricants can be used as normal.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection | Baseline (sample was collected up to 21 days form the date of registration) | Patient-collected vaginal swab HPV results compared with gold standard of clinician-collected cervical swab) to accurately detect HPV infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Acceptability of Using the Evalyn Brush | Baseline (sample was collected up to 21 days form the date of registration) | 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). |
Countries
United States
Participant flow
Recruitment details
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)
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Self-collected Vaginal Swab Samples at Clinic Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab
Swab kit (COBAS HPV 4800 Assay -Evalyn brush): Patient self-sampling swab kit to collect a vaginal sample for HPV testing
Clinician-collection of cervical 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) | 81 |
| Group 2: Self-collected Vaginal Swab Samples at Home Subjects will self-collect a vaginal swab (Evalyn brush) and complete a scheduled standard of care clinician-collected cervical swab
Swab kit (COBAS HPV 4800 Assay -Evalyn brush): Patient self-sampling swab kit to collect a vaginal sample for HPV testing
Clinician-collection of cervical 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) | 127 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Invalid Vaginal Swab | 2 | 2 |
| Overall Study | Missing Clinician Collection | 3 | 6 |
| Overall Study | Sample Lost in Transit | 1 | 0 |
| Overall Study | Screen Failure | 1 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 8 |
Baseline characteristics
| Characteristic | Group 1: Self-collected Vaginal Swab Samples at Clinic | Group 2: Self-collected Vaginal Swab Samples at Home | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants | 127 Participants | 208 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 77 Participants | 122 Participants | 199 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) White | 72 Participants | 114 Participants | 186 Participants |
| Region of Enrollment United States | 81 participants | 127 participants | 0 participants |
| Sex: Female, Male Female | 81 Participants | 127 Participants | 208 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 127 |
| other Total, other adverse events | 2 / 81 | 1 / 127 |
| serious Total, serious adverse events | 0 / 81 | 0 / 127 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Self-collected Vaginal Swab Samples at Clinic | Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection | HPV16 | 98 Total Percentage Agreement |
| Group 1: Self-collected Vaginal Swab Samples at Clinic | Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection | HPV18 | 99 Total Percentage Agreement |
| Group 1: Self-collected Vaginal Swab Samples at Clinic | Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection | Other HPV | 86 Total Percentage Agreement |
| Group 2: Self-collected Vaginal Swab Samples at Home | Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection | HPV16 | 94 Total Percentage Agreement |
| Group 2: Self-collected Vaginal Swab Samples at Home | Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection | HPV18 | 95 Total Percentage Agreement |
| Group 2: Self-collected Vaginal Swab Samples at Home | Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection | Other HPV | 89 Total Percentage Agreement |
Secondary
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)
Population: Survey results are reported for all participants who completed vaginal self-collection and returned the survey, even if the self-collection sample was deemed invalid or clinician sample was not received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Self-collected Vaginal Swab Samples at Clinic | Patient-reported Acceptability of Using the Evalyn Brush | Completely unacceptable | 0 Participants |
| Group 1: Self-collected Vaginal Swab Samples at Clinic | Patient-reported Acceptability of Using the Evalyn Brush | Unacceptable | 0 Participants |
| Group 1: Self-collected Vaginal Swab Samples at Clinic | Patient-reported Acceptability of Using the Evalyn Brush | Acceptable | 15 Participants |
| Group 1: Self-collected Vaginal Swab Samples at Clinic | Patient-reported Acceptability of Using the Evalyn Brush | Completely acceptable | 66 Participants |
| Group 2: Self-collected Vaginal Swab Samples at Home | Patient-reported Acceptability of Using the Evalyn Brush | Completely acceptable | 88 Participants |
| Group 2: Self-collected Vaginal Swab Samples at Home | Patient-reported Acceptability of Using the Evalyn Brush | Completely unacceptable | 0 Participants |
| Group 2: Self-collected Vaginal Swab Samples at Home | Patient-reported Acceptability of Using the Evalyn Brush | Acceptable | 37 Participants |
| Group 2: Self-collected Vaginal Swab Samples at Home | Patient-reported Acceptability of Using the Evalyn Brush | Unacceptable | 1 Participants |