Trial Outcomes & Findings for Patient Self-sampling of HPV to Screen for Cervical Cancer (NCT NCT05600283)
NCT ID: NCT05600283
Last Updated: 2026-01-06
Results Overview
Patient-collected vaginal swab HPV results compared with gold standard of clinician-collected cervical swab) to accurately detect HPV infection
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
222 participants
Primary outcome timeframe
Baseline (sample was collected up to 21 days form the date of registration)
Results posted on
2026-01-06
Participant Flow
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)
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
133
|
|
Overall Study
COMPLETED
|
79
|
115
|
|
Overall Study
NOT COMPLETED
|
10
|
18
|
Reasons for withdrawal
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
8
|
|
Overall Study
Invalid Vaginal Swab
|
2
|
2
|
|
Overall Study
Missing Clinician Collection
|
3
|
6
|
|
Overall Study
Screen Failure
|
1
|
2
|
|
Overall Study
Sample Lost in Transit
|
1
|
0
|
Baseline Characteristics
Patient Self-sampling of HPV to Screen for Cervical Cancer
Baseline characteristics by cohort
| Measure |
Group 1: Self-collected Vaginal Swab Samples at Clinic
n=81 Participants
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)
|
Group 2: Self-collected Vaginal Swab Samples at Home
n=127 Participants
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)
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
81 Participants
n=37 Participants
|
127 Participants
n=56 Participants
|
208 Participants
n=82 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=37 Participants
|
127 Participants
n=56 Participants
|
208 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=37 Participants
|
5 Participants
n=56 Participants
|
9 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
77 Participants
n=37 Participants
|
122 Participants
n=56 Participants
|
199 Participants
n=82 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
2 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
3 Participants
n=56 Participants
|
3 Participants
n=82 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=37 Participants
|
114 Participants
n=56 Participants
|
186 Participants
n=82 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=37 Participants
|
7 Participants
n=56 Participants
|
16 Participants
n=82 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=37 Participants
|
127 participants
n=56 Participants
|
0 participants
n=82 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Group 1: Self-collected Vaginal Swab Samples at Clinic
n=79 Participants
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)
|
Group 2: Self-collected Vaginal Swab Samples at Home
n=115 Participants
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)
|
|---|---|---|
|
Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection
HPV18
|
99 Total Percentage Agreement
|
95 Total Percentage Agreement
|
|
Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection
Other HPV
|
86 Total Percentage Agreement
|
89 Total Percentage Agreement
|
|
Concordance of Patient-collected and Clinician-collected Samples to Detect HPV Infection
HPV16
|
98 Total Percentage Agreement
|
94 Total Percentage Agreement
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Group 1: Self-collected Vaginal Swab Samples at Clinic
n=81 Participants
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)
|
Group 2: Self-collected Vaginal Swab Samples at Home
n=126 Participants
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)
|
|---|---|---|
|
Patient-reported Acceptability of Using the Evalyn Brush
Completely unacceptable
|
0 Participants
|
0 Participants
|
|
Patient-reported Acceptability of Using the Evalyn Brush
Unacceptable
|
0 Participants
|
1 Participants
|
|
Patient-reported Acceptability of Using the Evalyn Brush
Acceptable
|
15 Participants
|
37 Participants
|
|
Patient-reported Acceptability of Using the Evalyn Brush
Completely acceptable
|
66 Participants
|
88 Participants
|
Adverse Events
Group 1: Self-collected Vaginal Swab Samples at Clinic
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2: Self-collected Vaginal Swab Samples at Home
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Self-collected Vaginal Swab Samples at Clinic
n=81 participants at risk
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)
|
Group 2: Self-collected Vaginal Swab Samples at Home
n=127 participants at risk
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)
|
|---|---|---|
|
Product Issues
Participant inserted self-collection device with cap on (did not remove cap)
|
2.5%
2/81 • Number of events 2 • Baseline (at the time of swab collection). Participants collected swab samples up to 21 days from the time of enrollment.
|
0.00%
0/127 • Baseline (at the time of swab collection). Participants collected swab samples up to 21 days from the time of enrollment.
|
|
Product Issues
Device damaged during mailing to patient
|
0.00%
0/81 • Baseline (at the time of swab collection). Participants collected swab samples up to 21 days from the time of enrollment.
|
0.79%
1/127 • Number of events 1 • Baseline (at the time of swab collection). Participants collected swab samples up to 21 days from the time of enrollment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place