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=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Customized
36 to 45 years
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Customized
46 to 55 years
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Customized
56 to 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group · Burmese
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group · Hmong
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group · Karenn
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group · Karenni
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
78 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Highest Level of Education
College or Above
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Highest Level of Education
High School or Less
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Highest Level of Education
None
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Highest Level of Education
No Answer
|
30 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Employment Status
Employed
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Employment Status
Unemployed
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Employment Status
No Answer
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Marital Status
Married
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Marital Status
Single
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Marital Status
No Answer
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Insurance Status
Medicaid
|
48 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Insurance Status
Medicare
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Insurance Status
Private Insurance
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Insurance Status
No insurance
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Insurance Status
No answer
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Birth Country
United States
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Birth Country
Outside of the United States
|
70 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Years Living in the US
5 years or less
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Years Living in the US
6 to 10 years
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Years Living in the US
11 to 30 years
|
24 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Years Living in the US
more than 30 years
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Years Living in the US
No Answer
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Comfort with Written English
Very comfortable
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Comfort with Written English
Somewhat comfortable
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Comfort with Written English
Neutral
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Comfort with Written English
Somewhat uncomfortable
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Comfort with Written English
Not at all comfortable
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Comfort with Written English
No Answer
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Comfort with Oral (heard) English
Very comfortable
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Comfort with Oral (heard) English
Somewhat comfortable
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Comfort with Oral (heard) English
Neutral
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Comfort with Oral (heard) English
Somewhat uncomfortable
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Comfort with Oral (heard) English
Not at all comfortable
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Comfort with Oral (heard) English
No Answer
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Comfort with Written Native Language
Very comfortable
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Comfort with Written Native Language
Somewhat comfortable
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Comfort with Written Native Language
Neutral
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Comfort with Written Native Language
Somewhat uncomfortable
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Comfort with Written Native Language
Not at all comfortable
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Comfort with Written Native Language
No answer
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 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 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
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
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