Trial Outcomes & Findings for Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial (NCT NCT04679675)
NCT ID: NCT04679675
Last Updated: 2023-09-18
Results Overview
Rate of completing cervical cancer screening completion by outreach approach and prior screening behavior. Screening completion defined by returning the home kit and attending the recommended in clinic follow-up (if applicable); or receiving in clinic screening.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32771 participants
Primary outcome timeframe
Within 6 months of randomization
Results posted on
2023-09-18
Participant Flow
Participant milestones
| Measure |
Usual Care
Usual Care: Subjects will receive Kaiser Permanente Washington standard of care.
|
Education
Education: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening.
|
Direct Mail
Direct Mail: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will also receive an insert describing the home-based cervical cancer screening option and that a kit will be sent within 1 week. An HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
|
Opt-in
Opt-in: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will receive an Opt-in Insert describing the home-based cervical cancer screening option and how to request a kit. Individuals can request a kit by phone or through a webpage. Individuals who request a kit will receive the HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12709
|
9279
|
2974
|
7809
|
|
Overall Study
COMPLETED
|
12142
|
8854
|
2897
|
7462
|
|
Overall Study
NOT COMPLETED
|
567
|
425
|
77
|
347
|
Reasons for withdrawal
| Measure |
Usual Care
Usual Care: Subjects will receive Kaiser Permanente Washington standard of care.
|
Education
Education: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening.
|
Direct Mail
Direct Mail: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will also receive an insert describing the home-based cervical cancer screening option and that a kit will be sent within 1 week. An HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
|
Opt-in
Opt-in: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will receive an Opt-in Insert describing the home-based cervical cancer screening option and how to request a kit. Individuals can request a kit by phone or through a webpage. Individuals who request a kit will receive the HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
|
|---|---|---|---|---|
|
Overall Study
Excluded from analysis, recent Papanicolaou test prior to randomization date
|
356
|
261
|
50
|
210
|
|
Overall Study
Excluded from analysis, recent disenrollment from KPWA
|
211
|
164
|
27
|
137
|
Baseline Characteristics
Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial
Baseline characteristics by cohort
| Measure |
Usual Care
n=12142 Participants
Usual Care: Subjects will receive Kaiser Permanente Washington standard of care.
|
Education
n=8854 Participants
Education: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening.
|
Direct Mail
n=2897 Participants
Direct Mail: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will also receive an insert describing the home-based cervical cancer screening option and that a kit will be sent within 1 week. An HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
|
Opt-in
n=7462 Participants
Opt-in: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will receive an Opt-in Insert describing the home-based cervical cancer screening option and how to request a kit. Individuals can request a kit by phone or through a webpage. Individuals who request a kit will receive the HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
|
Total
n=31355 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12142 Participants
n=5 Participants
|
8854 Participants
n=7 Participants
|
2897 Participants
n=5 Participants
|
7462 Participants
n=4 Participants
|
31355 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
45.1 years
STANDARD_DEVIATION 10.5 • n=4 Participants
|
45.9 years
STANDARD_DEVIATION 10.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12142 Participants
n=5 Participants
|
8854 Participants
n=7 Participants
|
2897 Participants
n=5 Participants
|
7462 Participants
n=4 Participants
|
31355 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
628 Participants
n=5 Participants
|
502 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
421 Participants
n=4 Participants
|
1705 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8047 Participants
n=5 Participants
|
5278 Participants
n=7 Participants
|
2307 Participants
n=5 Participants
|
4446 Participants
n=4 Participants
|
20078 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3467 Participants
n=5 Participants
|
3074 Participants
n=7 Participants
|
436 Participants
n=5 Participants
|
2595 Participants
n=4 Participants
|
9572 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
76 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
183 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1298 Participants
n=5 Participants
|
919 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
861 Participants
n=4 Participants
|
3404 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
153 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
372 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
553 Participants
n=5 Participants
|
411 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
315 Participants
n=4 Participants
|
1412 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7175 Participants
n=5 Participants
|
4844 Participants
n=7 Participants
|
1902 Participants
n=5 Participants
|
4176 Participants
n=4 Participants
|
18097 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
353 Participants
n=5 Participants
|
261 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
914 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2534 Participants
n=5 Participants
|
2249 Participants
n=7 Participants
|
398 Participants
n=5 Participants
|
1792 Participants
n=4 Participants
|
6973 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12142 participants
n=5 Participants
|
8854 participants
n=7 Participants
|
2897 participants
n=5 Participants
|
7462 participants
n=4 Participants
|
31355 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Within 6 months of randomizationRate of completing cervical cancer screening completion by outreach approach and prior screening behavior. Screening completion defined by returning the home kit and attending the recommended in clinic follow-up (if applicable); or receiving in clinic screening.
Outcome measures
| Measure |
Usual Care
n=12142 Participants
Usual Care: Subjects will receive Kaiser Permanente Washington standard of care.
|
Education
n=8854 Participants
Education: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening.
|
Direct Mail
n=2897 Participants
Direct Mail: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will also receive an insert describing the home-based cervical cancer screening option and that a kit will be sent within 1 week. An HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
|
Opt-in
n=7462 Participants
Opt-in: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will receive an Opt-in Insert describing the home-based cervical cancer screening option and how to request a kit. Individuals can request a kit by phone or through a webpage. Individuals who request a kit will receive the HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
|
|---|---|---|---|---|
|
Screening Completion by Outreach Approach and Prior Screening Behavior
Screening-Adherent
|
3671 Participants
|
3960 Participants
|
1482 Participants
|
3956 Participants
|
|
Screening Completion by Outreach Approach and Prior Screening Behavior
Unknown
|
2983 Participants
|
3486 Participants
|
0 Participants
|
3506 Participants
|
|
Screening Completion by Outreach Approach and Prior Screening Behavior
Overdue
|
5488 Participants
|
1408 Participants
|
1415 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 6 months of randomizationIncremental cost-effectiveness ratio, which will be defined for each outreach approach within each screening behavior subgroup. Also, comparisons across screening behavior subgroups of usual care plus education to usual care.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 6 months of randomizationScreening Initiation defined as returning the home kit or receiving in clinic cervical cancer screening.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 6 months of randomizationTime from randomization to screening completion by outreach approach and prior screening behavior. Screening completion defined by returning the home kit and attending the recommended in clinic follow-up (if applicable); or receiving in clinic screening.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 6 months of randomizationProportion of intervention group women who complete recommended follow-up after a positive kit result by outreach approach and prior screening behavior. Per current guidelines, in-clinic Pap after other-HR HPV positive; or colposcopy after HPV 16/18+ HPV self-collection
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 6 months of randomizationProportion of intervention group women who do not screen, return the home kit or receive in-clinic screening by outreach approach and prior screening behavior. Screening uptake outcome (no screen, home kit, or in-clinic) by outreach approach and by prior screening behavior
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6-12 months following study invitationThrough focus groups, the investigators will explore patient preference for, and satisfaction with, home HPV screening and barriers to follow-up of abnormal screening results.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3-5 years (projected)Economic assessment of system-level financial consequences of adopting home-based HPV screening for cervical cancer. These analyses will evaluate the needed time to follow-up for the next cervical cancer screening to reduce gaps in cervical cancer screening HEDIS metrics, which also addresses program affordability.
Outcome measures
Outcome data not reported
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Direct Mail
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Opt-in
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Usual Care
n=12142 participants at risk
Usual Care: Subjects will receive Kaiser Permanente Washington standard of care.
|
Education
n=8854 participants at risk
Education: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening.
|
Direct Mail
n=2897 participants at risk
Direct Mail: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will also receive an insert describing the home-based cervical cancer screening option and that a kit will be sent within 1 week. An HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
|
Opt-in
n=7462 participants at risk
Opt-in: Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will receive an Opt-in Insert describing the home-based cervical cancer screening option and how to request a kit. Individuals can request a kit by phone or through a webpage. Individuals who request a kit will receive the HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Dysuria
|
0.00%
0/12142 • Adverse event data was collected within 6 months of randomization.
Usual Care and Education arm participants are not at risk for adverse events because they did not use, nor have the option to use, a self-collect screening kit.
|
0.00%
0/8854 • Adverse event data was collected within 6 months of randomization.
Usual Care and Education arm participants are not at risk for adverse events because they did not use, nor have the option to use, a self-collect screening kit.
|
0.07%
2/2897 • Number of events 2 • Adverse event data was collected within 6 months of randomization.
Usual Care and Education arm participants are not at risk for adverse events because they did not use, nor have the option to use, a self-collect screening kit.
|
0.03%
2/7462 • Number of events 2 • Adverse event data was collected within 6 months of randomization.
Usual Care and Education arm participants are not at risk for adverse events because they did not use, nor have the option to use, a self-collect screening kit.
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/12142 • Adverse event data was collected within 6 months of randomization.
Usual Care and Education arm participants are not at risk for adverse events because they did not use, nor have the option to use, a self-collect screening kit.
|
0.00%
0/8854 • Adverse event data was collected within 6 months of randomization.
Usual Care and Education arm participants are not at risk for adverse events because they did not use, nor have the option to use, a self-collect screening kit.
|
0.07%
2/2897 • Number of events 2 • Adverse event data was collected within 6 months of randomization.
Usual Care and Education arm participants are not at risk for adverse events because they did not use, nor have the option to use, a self-collect screening kit.
|
0.01%
1/7462 • Number of events 1 • Adverse event data was collected within 6 months of randomization.
Usual Care and Education arm participants are not at risk for adverse events because they did not use, nor have the option to use, a self-collect screening kit.
|
Additional Information
Dr. Beverly Green
Kaiser Permanente Washington Health Research Institute
Phone: 206-220-2997
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place