Cervical Cancer Self-Collection for Southeast Asian Immigrant and Refugee Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Community Health Outreach to Increase Cervical Cancer Education and Self-Collection Screening (CHOICESS) Program for Southeast Asian Immigrant and Refugee Women in Wisconsin

Conditions
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Cervical Cancer Screening

Intervention / Treatment
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* Procedure: Workshop plus Clinician-Collected Cervical Swab
* Device: Workshop plus Participant-Collected Cervical Swab
* Diagnostic Test: HPV testing on Participant-Collected Cervical Swab Samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fluent understanding in English, Hmong, Karen, Burmese, or Karenni Exclusion Criteria: Prior hysterectomy Impaired decision-making capacity Pregnancy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Workshops are randomized to either a control or intervention group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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. | Procedure: Workshop plus Clinician-Collected Cervical Swab<br>* clinician-collection methods using speculum and cervical swabs<br>|
| Experimental: Intervention<br>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. | Device: Workshop plus Participant-Collected Cervical Swab<br>* Evalyn® Brush (Rovers® Medical Devices, Netherlands)<br>Diagnostic Test: HPV testing on Participant-Collected Cervical Swab Samples<br>* Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 5 to 20 where higher scores are a proxy for positive workshop impact on participant. Additional items will include open ended questions on satisfaction. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-collection, community health workers