Trial Outcomes & Findings for Cervical Cancer Self-Collection for Southeast Asian Immigrant and Refugee Women (NCT NCT05286749)
NCT ID: NCT05286749
Last Updated: 2024-09-19
Results Overview
The results will be reported through summary statistics of the number of participants in each group subsequently engaging or seeking out cervical cancer screening either through services offered after workshop education or self-reported desire to follow up through their community health care provider.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
153 participants
Primary outcome timeframe
up to 1 day
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Control
Participants take a workshop where they are provided education on standard-of-care for cervical cancer screening such as pap smear and HPV testing through clinician-collection methods using speculum and cervical swabs.
Workshop plus Clinician-Collected Cervical Swab: clinician-collection methods using speculum and cervical swabs
|
Intervention
Participants take a workshop where they are provided all the same education as control as well as additional education on self-collection for HPV-only testing using vaginal swab as an additional method.
Workshop plus Participant-Collected Cervical Swab: Evalyn® Brush (Rovers® Medical Devices, Netherlands)
HPV testing on Participant-Collected Cervical Swab Samples: Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
78
|
|
Overall Study
COMPLETED
|
75
|
78
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cervical Cancer Self-Collection for Southeast Asian Immigrant and Refugee Women
Baseline characteristics by cohort
| Measure |
Control
n=75 Participants
Participants take a workshop where they are provided education on standard-of-care for cervical cancer screening such as pap smear and HPV testing through clinician-collection methods using speculum and cervical swabs.
Workshop plus Clinician-Collected Cervical Swab: clinician-collection methods using speculum and cervical swabs
|
Intervention
n=78 Participants
Participants take a workshop where they are provided all the same education as control as well as additional education on self-collection for HPV-only testing using vaginal swab as an additional method.
Workshop plus Participant-Collected Cervical Swab: Evalyn® Brush (Rovers® Medical Devices, Netherlands)
HPV testing on Participant-Collected Cervical Swab Samples: Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
25 to 35 years
|
26 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Age, Customized
36 to 45 years
|
19 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Age, Customized
46 to 55 years
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Age, Customized
56 to 65 years
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group · Burmese
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group · Hmong
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group · Karenn
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group · Karenni
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=99 Participants
|
78 participants
n=107 Participants
|
153 participants
n=206 Participants
|
|
Highest Level of Education
College or Above
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Highest Level of Education
High School or Less
|
27 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Highest Level of Education
None
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Highest Level of Education
No Answer
|
30 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Employment Status
Employed
|
34 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Employment Status
Unemployed
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Employment Status
No Answer
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Marital Status
Married
|
50 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Marital Status
Single
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Marital Status
No Answer
|
5 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Insurance Status
Medicaid
|
48 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Insurance Status
Medicare
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Insurance Status
Private Insurance
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Insurance Status
No insurance
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Insurance Status
No answer
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Birth Country
United States
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Birth Country
Outside of the United States
|
70 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
|
Years Living in the US
5 years or less
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Years Living in the US
6 to 10 years
|
15 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Years Living in the US
11 to 30 years
|
24 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Years Living in the US
more than 30 years
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Years Living in the US
No Answer
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Comfort with Written English
Very comfortable
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Comfort with Written English
Somewhat comfortable
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Comfort with Written English
Neutral
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Comfort with Written English
Somewhat uncomfortable
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Comfort with Written English
Not at all comfortable
|
27 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Comfort with Written English
No Answer
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Comfort with Oral (heard) English
Very comfortable
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Comfort with Oral (heard) English
Somewhat comfortable
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Comfort with Oral (heard) English
Neutral
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Comfort with Oral (heard) English
Somewhat uncomfortable
|
13 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Comfort with Oral (heard) English
Not at all comfortable
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Comfort with Oral (heard) English
No Answer
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Comfort with Written Native Language
Very comfortable
|
24 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Comfort with Written Native Language
Somewhat comfortable
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Comfort with Written Native Language
Neutral
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Comfort with Written Native Language
Somewhat uncomfortable
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Comfort with Written Native Language
Not at all comfortable
|
22 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Comfort with Written Native Language
No answer
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 1 dayThe results will be reported through summary statistics of the number of participants in each group subsequently engaging or seeking out cervical cancer screening either through services offered after workshop education or self-reported desire to follow up through their community health care provider.
Outcome measures
| Measure |
Control
n=75 Participants
Participants take a workshop where they are provided education on standard-of-care for cervical cancer screening such as pap smear and HPV testing through clinician-collection methods using speculum and cervical swabs.
Workshop plus Clinician-Collected Cervical Swab: clinician-collection methods using speculum and cervical swabs
|
Intervention
n=78 Participants
Participants take a workshop where they are provided all the same education as control as well as additional education on self-collection for HPV-only testing using vaginal swab as an additional method.
Workshop plus Participant-Collected Cervical Swab: Evalyn® Brush (Rovers® Medical Devices, Netherlands)
HPV testing on Participant-Collected Cervical Swab Samples: Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)
|
|---|---|---|
|
Number of Participants Who Obtain or Self-Report Future Desire for Cervical Cancer Screening
|
59 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: up to 1 day (pre workshop and post-workshop, up to 3 hours between surveys)Participant satisfaction with the educational workshops will be assessed using mixed methods satisfaction surveys. 4-items on the pre- and post-workshop surveys scored on a 5 point likert scale from 1 (not likely) to 5 (very likely) for a total possible range of scores from 1 to 5 where higher scores are a proxy for positive workshop impact on participant. Additional items will include open ended questions on satisfaction.
Outcome measures
| Measure |
Control
n=75 Participants
Participants take a workshop where they are provided education on standard-of-care for cervical cancer screening such as pap smear and HPV testing through clinician-collection methods using speculum and cervical swabs.
Workshop plus Clinician-Collected Cervical Swab: clinician-collection methods using speculum and cervical swabs
|
Intervention
n=78 Participants
Participants take a workshop where they are provided all the same education as control as well as additional education on self-collection for HPV-only testing using vaginal swab as an additional method.
Workshop plus Participant-Collected Cervical Swab: Evalyn® Brush (Rovers® Medical Devices, Netherlands)
HPV testing on Participant-Collected Cervical Swab Samples: Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)
|
|---|---|---|
|
Participant Satisfaction With Educational Workshops Survey Scores
Likelihood to encourage your family members to get screened
|
4.71 score on a scale
Standard Deviation 0.653
|
4.74 score on a scale
Standard Deviation 0.653
|
|
Participant Satisfaction With Educational Workshops Survey Scores
Likelihood to get pap in future
|
4.6 score on a scale
Standard Deviation 0.854
|
4.44 score on a scale
Standard Deviation 1.112
|
|
Participant Satisfaction With Educational Workshops Survey Scores
Likelihood to spread word about screenings to family/friends
|
4.76 score on a scale
Standard Deviation 0.654
|
4.63 score on a scale
Standard Deviation 0.913
|
|
Participant Satisfaction With Educational Workshops Survey Scores
Practice healthy behaviors to reduce risk
|
4.73 score on a scale
Standard Deviation 0.664
|
4.88 score on a scale
Standard Deviation 0.394
|
SECONDARY outcome
Timeframe: up to 1 dayGeneral willingness to use a HPV self-collect device at home and/or as the preferred collection method for cervical cancer screening, assessed via mixed methods survey.
Outcome measures
| Measure |
Control
n=75 Participants
Participants take a workshop where they are provided education on standard-of-care for cervical cancer screening such as pap smear and HPV testing through clinician-collection methods using speculum and cervical swabs.
Workshop plus Clinician-Collected Cervical Swab: clinician-collection methods using speculum and cervical swabs
|
Intervention
n=78 Participants
Participants take a workshop where they are provided all the same education as control as well as additional education on self-collection for HPV-only testing using vaginal swab as an additional method.
Workshop plus Participant-Collected Cervical Swab: Evalyn® Brush (Rovers® Medical Devices, Netherlands)
HPV testing on Participant-Collected Cervical Swab Samples: Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)
|
|---|---|---|
|
Number of Participants Willing to Use HPV Self-collect Device for Their Cervical Cancer Screening
|
6 Participants
|
1 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
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
Tana Chongsuwat, MD, MPH
UW School of Medicine and Public Health
Phone: 224-260-1666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place