Cervical Cancer Screening
Conditions
Keywords
self-collection, community health workers
Brief summary
The primary purpose of this study is to determine whether educational workshops paired with self-collected high-risk human papillomaviruses (hrHPV) screening will increase participation in cervical cancer screening among Southeast Asian Immigrant and Refugee populations in Wisconsin compared with offering clinician collected screening (total sample size: 250 participants). The investigators hypothesize that participation in cervical cancer screening will be higher among women in the intervention group as compared to the control group.
Detailed description
The effectiveness of offering self-collection sampling options to Southeast Asian refugee and immigrant populations to improve cervical cancer screening participation has not been investigated. The Milwaukee Consortium for Hmong Health (MCHH), supported by the Well Woman Program, has had success increasing participation in breast cancer screening through outreach and education activities. However, it continues to have limited success engaging women in cervical cancer screening. The investigators have established a partnership with MCHH to develop innovative cervical cancer workshops that combine community health worker (CHW)-led engagement with self-collected hrHPV screening, with the primary objective of increasing participation, awareness, and engagement in cervical cancer screening and treatment activities among this population. Research Intervention: Control workshops are workshops where participants 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. Intervention workshops are workshops where participants 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. After each workshop, each group will be offered to participate in their assigned group's screening method (clinician-collected or self-collected). * Primary Objective: To evaluate whether educational workshops paired with self-collected hrHPV screening will increase participation in cervical cancer screening among Southeast Asian refugee and immigrant populations in Wisconsin compared with offering clinician-collected screening. * Secondary Objectives: To evaluate participant satisfaction with the educational workshops using satisfaction surveys.
Interventions
PROCEDUREWorkshop plus Clinician-Collected Cervical Swab
clinician-collection methods using speculum and cervical swabs
DEVICEWorkshop plus Participant-Collected Cervical Swab
Evalyn® Brush (Rovers® Medical Devices, Netherlands)
DIAGNOSTIC_TESTHPV testing on Participant-Collected Cervical Swab Samples
Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)
Sponsors
Milwaukee Consortium for Hmong Health (MCHH)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
Participants will be informed of random assignment into two groups. Participants will not be aware of which group they belong to. Participants in the control group are initially only provided educational materials about the standard of care for cervical cancer screening and offered clinician-collection for screening as the recommended method. Whereas the intervention group is provided additional materials about self-collection in the core educational material and is offered the Evalyn Device for self-collection as a screening option immediately at the end of the workshop. All participants will be made aware during a debrief session at the end of the study about what information could not be given at the time of consenting, and why they could not be told at that time.
Intervention model description
Workshops are randomized to either a control or intervention group
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Fluent understanding in English, Hmong, Karen, Burmese, or Karenni
Exclusion criteria
* Prior hysterectomy * Impaired decision-making capacity * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Obtain or Self-Report Future Desire for Cervical Cancer Screening | up to 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction With Educational Workshops Survey Scores | 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. |
| Number of Participants Willing to Use HPV Self-collect Device for Their Cervical Cancer Screening | up to 1 day | General 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 75 |
| 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) | 78 |
| Total | 153 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Customized 25 to 35 years | 20 Participants | 26 Participants | 46 Participants |
| Age, Customized 36 to 45 years | 23 Participants | 19 Participants | 42 Participants |
| Age, Customized 46 to 55 years | 19 Participants | 15 Participants | 34 Participants |
| Age, Customized 56 to 65 years | 16 Participants | 15 Participants | 31 Participants |
| Birth Country Outside of the United States | 77 Participants | 70 Participants | 147 Participants |
| Birth Country United States | 1 Participants | 5 Participants | 6 Participants |
| Comfort with Oral (heard) English Neutral | 16 Participants | 17 Participants | 33 Participants |
| Comfort with Oral (heard) English No Answer | 3 Participants | 2 Participants | 5 Participants |
| Comfort with Oral (heard) English Not at all comfortable | 26 Participants | 25 Participants | 51 Participants |
| Comfort with Oral (heard) English Somewhat comfortable | 6 Participants | 9 Participants | 15 Participants |
| Comfort with Oral (heard) English Somewhat uncomfortable | 20 Participants | 13 Participants | 33 Participants |
| Comfort with Oral (heard) English Very comfortable | 7 Participants | 9 Participants | 16 Participants |
| Comfort with Written English Neutral | 19 Participants | 19 Participants | 38 Participants |
| Comfort with Written English No Answer | 2 Participants | 2 Participants | 4 Participants |
| Comfort with Written English Not at all comfortable | 32 Participants | 27 Participants | 59 Participants |
| Comfort with Written English Somewhat comfortable | 6 Participants | 6 Participants | 12 Participants |
| Comfort with Written English Somewhat uncomfortable | 14 Participants | 11 Participants | 25 Participants |
| Comfort with Written English Very comfortable | 5 Participants | 10 Participants | 15 Participants |
| Comfort with Written Native Language Neutral | 11 Participants | 9 Participants | 20 Participants |
| Comfort with Written Native Language No answer | 4 Participants | 3 Participants | 7 Participants |
| Comfort with Written Native Language Not at all comfortable | 19 Participants | 22 Participants | 41 Participants |
| Comfort with Written Native Language Somewhat comfortable | 9 Participants | 12 Participants | 21 Participants |
| Comfort with Written Native Language Somewhat uncomfortable | 6 Participants | 5 Participants | 11 Participants |
| Comfort with Written Native Language Very comfortable | 29 Participants | 24 Participants | 53 Participants |
| Employment Status Employed | 36 Participants | 34 Participants | 70 Participants |
| Employment Status No Answer | 12 Participants | 11 Participants | 23 Participants |
| Employment Status Unemployed | 30 Participants | 30 Participants | 60 Participants |
| Highest Level of Education College or Above | 8 Participants | 10 Participants | 18 Participants |
| Highest Level of Education High School or Less | 34 Participants | 27 Participants | 61 Participants |
| Highest Level of Education No Answer | 23 Participants | 30 Participants | 53 Participants |
| Highest Level of Education None | 13 Participants | 8 Participants | 21 Participants |
| Insurance Status Medicaid | 42 Participants | 48 Participants | 90 Participants |
| Insurance Status Medicare | 3 Participants | 0 Participants | 3 Participants |
| Insurance Status No answer | 4 Participants | 0 Participants | 4 Participants |
| Insurance Status No insurance | 10 Participants | 9 Participants | 19 Participants |
| Insurance Status Private Insurance | 19 Participants | 18 Participants | 37 Participants |
| Marital Status Married | 48 Participants | 50 Participants | 98 Participants |
| Marital Status No Answer | 14 Participants | 5 Participants | 19 Participants |
| Marital Status Single | 16 Participants | 20 Participants | 36 Participants |
| Race/Ethnicity, Customized Ethnic Group Burmese | 19 Participants | 18 Participants | 37 Participants |
| Race/Ethnicity, Customized Ethnic Group Hmong | 18 Participants | 17 Participants | 35 Participants |
| Race/Ethnicity, Customized Ethnic Group Karenn | 15 Participants | 13 Participants | 28 Participants |
| Race/Ethnicity, Customized Ethnic Group Karenni | 26 Participants | 27 Participants | 53 Participants |
| Region of Enrollment United States | 78 participants | 75 participants | 153 participants |
| Sex: Female, Male Female | 78 Participants | 75 Participants | 153 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Years Living in the US 11 to 30 years | 34 Participants | 24 Participants | 58 Participants |
| Years Living in the US 5 years or less | 4 Participants | 8 Participants | 12 Participants |
| Years Living in the US 6 to 10 years | 21 Participants | 15 Participants | 36 Participants |
| Years Living in the US more than 30 years | 10 Participants | 15 Participants | 25 Participants |
| Years Living in the US No Answer | 9 Participants | 13 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 78 |
| other Total, other adverse events | 0 / 75 | 0 / 78 |
| serious Total, serious adverse events | 0 / 75 | 0 / 78 |
Outcome results
Primary
Number of Participants Who Obtain or Self-Report Future Desire for Cervical Cancer Screening
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.
Time frame: up to 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants Who Obtain or Self-Report Future Desire for Cervical Cancer Screening | 59 Participants |
| Intervention | Number of Participants Who Obtain or Self-Report Future Desire for Cervical Cancer Screening | 71 Participants |
Secondary
Number of Participants Willing to Use HPV Self-collect Device for Their Cervical Cancer Screening
General 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.
Time frame: up to 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants Willing to Use HPV Self-collect Device for Their Cervical Cancer Screening | 6 Participants |
| Intervention | Number of Participants Willing to Use HPV Self-collect Device for Their Cervical Cancer Screening | 1 Participants |
Secondary
Participant Satisfaction With Educational Workshops Survey Scores
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.
Time frame: up to 1 day (pre workshop and post-workshop, up to 3 hours between surveys)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Participant Satisfaction With Educational Workshops Survey Scores | Likelihood to get pap in future | 4.6 score on a scale | Standard Deviation 0.854 |
| Control | 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 |
| Control | 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 |
| Control | Participant Satisfaction With Educational Workshops Survey Scores | Practice healthy behaviors to reduce risk | 4.73 score on a scale | Standard Deviation 0.664 |
| Intervention | Participant Satisfaction With Educational Workshops Survey Scores | Practice healthy behaviors to reduce risk | 4.88 score on a scale | Standard Deviation 0.394 |
| Intervention | Participant Satisfaction With Educational Workshops Survey Scores | Likelihood to get pap in future | 4.44 score on a scale | Standard Deviation 1.112 |
| Intervention | Participant Satisfaction With Educational Workshops Survey Scores | Likelihood to encourage your family members to get screened | 4.74 score on a scale | Standard Deviation 0.653 |
| Intervention | Participant Satisfaction With Educational Workshops Survey Scores | Likelihood to spread word about screenings to family/friends | 4.63 score on a scale | Standard Deviation 0.913 |