Trial Outcomes & Findings for Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care (NCT NCT02698423)
NCT ID: NCT02698423
Last Updated: 2018-06-06
Results Overview
Compare the participation rate to cervical cancer screening for home-based human papillomavirus testing based on self-sampling versus clinic-based, physician-performed Pap testing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
667 participants
Primary outcome timeframe
1 year
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Cobas HPV DNA Test
Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing.
|
Papanicolau Test
Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Papanicolau test: Women will be invited to come in for a physician-performed Pap test.
|
|---|---|---|
|
Overall Study
STARTED
|
336
|
331
|
|
Overall Study
COMPLETED
|
317
|
307
|
|
Overall Study
NOT COMPLETED
|
19
|
24
|
Reasons for withdrawal
| Measure |
Cobas HPV DNA Test
Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing.
|
Papanicolau Test
Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Papanicolau test: Women will be invited to come in for a physician-performed Pap test.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
24
|
Baseline Characteristics
Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care
Baseline characteristics by cohort
| Measure |
Cobas HPV DNA Test
n=336 Participants
Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing
|
Papanicolau Test
n=331 Participants
Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Papanicolau test: Women will be invited to come in for a physician-performed Pap test
|
Total
n=667 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 10.9 • n=113 Participants
|
42.1 years
STANDARD_DEVIATION 10.8 • n=163 Participants
|
42.2 years
STANDARD_DEVIATION 10.9 • n=160 Participants
|
|
Sex: Female, Male
Female
|
336 Participants
n=113 Participants
|
331 Participants
n=163 Participants
|
667 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
105 Participants
n=113 Participants
|
106 Participants
n=163 Participants
|
211 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
231 Participants
n=113 Participants
|
225 Participants
n=163 Participants
|
456 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Relationship Status
With a partner
|
161 Participants
n=113 Participants
|
154 Participants
n=163 Participants
|
315 Participants
n=160 Participants
|
|
Relationship Status
Single
|
175 Participants
n=113 Participants
|
177 Participants
n=163 Participants
|
352 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: 1 yearCompare the participation rate to cervical cancer screening for home-based human papillomavirus testing based on self-sampling versus clinic-based, physician-performed Pap testing.
Outcome measures
| Measure |
Cobas HPV DNA Test
n=336 Participants
Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. N=336
|
Papanicolau Test
n=331 Participants
Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Papanicolau test: Women will be invited to come in for a physician-performed Pap test.
N=331
|
|---|---|---|
|
Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing
|
317 Participants
|
307 Participants
|
SECONDARY outcome
Timeframe: 1 yearAssess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening.
Outcome measures
| Measure |
Cobas HPV DNA Test
n=336 Participants
Women will be invited to perform HPV self-testing with the Cobas HPV DNA test at home.
Cobas HPV DNA Test: Women will receive a home-sent sample for HPV self-testing. N=336
|
Papanicolau Test
n=331 Participants
Women will be invited to come to the hospital to undergo a Papanicolau test (Pap test), which will be performed by the clinician.
Papanicolau test: Women will be invited to come in for a physician-performed Pap test.
N=331
|
|---|---|---|
|
Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.
|
317 Participants
|
307 Participants
|
Adverse Events
Cobas HPV DNA Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Papanicolau Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place