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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 8/8/2023 | Other Identifier | UW Madison | |
| UW21142 | Other Identifier | UWCCC | |
| A532050 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Milwaukee Consortium for Hmong Health (MCHH) | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 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. |
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| Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Workshop plus Clinician-Collected Cervical Swab | Procedure | clinician-collection methods using speculum and cervical swabs |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Dalby, MD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MCHH's Community Center | Milwaukee | Wisconsin | 53205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2023 |
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Workshops are randomized to either a control or intervention group
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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.
| Workshop plus Participant-Collected Cervical Swab | Device | Evalyn® Brush (Rovers® Medical Devices, Netherlands) |
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| HPV testing on Participant-Collected Cervical Swab Samples | Diagnostic Test | Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland) |
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| up to 1 day (pre workshop and post-workshop, up to 3 hours between surveys) |
| 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. | up to 1 day |
| FG001 |
| 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) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Highest Level of Education | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Insurance Status | Count of Participants | Participants |
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| Birth Country | Count of Participants | Participants |
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| Years Living in the US | Count of Participants | Participants |
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| Comfort with Written English | Count of Participants | Participants |
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| Comfort with Oral (heard) English | Count of Participants | Participants |
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| Comfort with Written Native Language | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | up to 1 day |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | up to 1 day (pre workshop and post-workshop, up to 3 hours between surveys) |
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| 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. | Posted | Count of Participants | Participants | up to 1 day |
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data collected during 1 study visit, up to 3 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 75 | 0 | 75 | 0 | 75 |
| EG001 | 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) | 0 | 78 | 0 | 78 | 0 | 78 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tana Chongsuwat, MD, MPH | UW School of Medicine and Public Health | 224-260-1666 | tana.chongsuwat@fammed.wisc.edu |
| Aug 5, 2024 |
| Prot_SAP_000.pdf |
| 46 to 55 years |
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| 56 to 65 years |
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| Male |
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| Hmong |
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| Karenn |
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| Karenni |
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| High School or Less |
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| None |
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| No Answer |
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| Unemployed |
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| No Answer |
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| Single |
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| No Answer |
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| Medicare |
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| Private Insurance |
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| No insurance |
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| No answer |
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| Outside of the United States |
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| 6 to 10 years |
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| 11 to 30 years |
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| more than 30 years |
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| No Answer |
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| Somewhat comfortable |
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| Neutral |
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| Somewhat uncomfortable |
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| Not at all comfortable |
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| No Answer |
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| Somewhat comfortable |
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| Neutral |
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| Somewhat uncomfortable |
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| Not at all comfortable |
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| No Answer |
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| Somewhat comfortable |
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| Neutral |
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| Somewhat uncomfortable |
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| Not at all comfortable |
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| No answer |
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| Participants |
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