Trial Outcomes & Findings for Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention (NCT NCT03613493)
NCT ID: NCT03613493
Last Updated: 2019-08-02
Results Overview
Number of participants that used and returned their self-sampler kit was evaluated.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
2 weeks
Results posted on
2019-08-02
Participant Flow
Participant milestones
| Measure |
HPV Self-sampling Kit + Interview
Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative).
|
Culturally-targeted Fear Appeal Message HPV Self-sampling Kit
Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.
|
Fear Appeal Message HPV Self-sampling Kit
Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit.
|
HPV Self-sampling Kit
Participants will receive an HPV self-sampling kit to screen for HPV
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
75
|
0
|
90
|
|
Overall Study
Enrollment Criteria Met
|
10
|
74
|
0
|
89
|
|
Overall Study
COMPLETED
|
10
|
73
|
0
|
83
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acceptability of Human Papillomavirus (HPV) Self-sampling Tools for Cervical Cancer Prevention
Baseline characteristics by cohort
| Measure |
HPV Self-sampling Kit + Interview
n=10 Participants
Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative).
|
Culturally-targeted Fear Appeal Message HPV Self-sampling Kit
n=74 Participants
Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.
|
Fear Appeal Message HPV Self-sampling Kit
Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit.
|
HPV Self-sampling Kit
n=89 Participants
Participants will receive an HPV self-sampling kit to screen for HPV
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.40 Years
STANDARD_DEVIATION 9.442 • n=5 Participants
|
45.01 Years
STANDARD_DEVIATION 9.099 • n=7 Participants
|
—
|
41.09 Years
STANDARD_DEVIATION 10.222 • n=4 Participants
|
44.50 Years
STANDARD_DEVIATION 9.587 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
173 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
|
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)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
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
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Prior pap test experience
|
7 participants
n=5 Participants
|
64 participants
n=7 Participants
|
—
|
72 participants
n=4 Participants
|
143 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Data was not collected for the fear appeal message HPV self-sampling condition due to lack of funding.
Number of participants that used and returned their self-sampler kit was evaluated.
Outcome measures
| Measure |
Culturally-targeted Fear Appeal Message HPV Self-sampling Kit
n=74 Participants
Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
Culturally-targeted Fear Appeal Message: Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.
|
Fear Appeal Message HPV Self-sampling Kit
Participants will receive an HPV self-sampling kit to screen for HPV, accompanied by a culturally-targeted fear appeal message
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
Fear Appeal Message: Participants will receive fear appeal messages (only) in a graphically designed kit.
|
HPV Self-sampling Kit
n=89 Participants
Participants will receive an HPV self-sampling kit to screen for HPV
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
|
HPV Self-sampling Kit + Interview
n=10 Participants
Participants will receive an HPV self-sampling kit to screen for HPV and then are interviewed about their experience using the tool.
HPV self-sampling kit: The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
Interview: Participants will be interviewed about experiences using the self-sampling tool (qualitative).
|
|---|---|---|---|---|
|
Number of Participants That Used and Returned Their Self-sampler Kit.
|
73 Participants
|
—
|
83 Participants
|
10 Participants
|
Adverse Events
HPV Self-sampling Kit + Interview
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Culturally-targeted Fear Appeal Message HPV Self-sampling Kit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HPV Self-sampling Kit
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