Cervical Cancer Self-Collection for Hmong and Karenni Women
Primary Purpose
Cervical Cancer Screening
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Workshop plus Clinician-Collected Cervical Swab
Workshop plus Participant-Collected Cervical Swab
HPV testing on Participant-Collected Cervical Swab Samples
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer Screening focused on measuring self-collection, community health workers
Eligibility Criteria
Inclusion Criteria:
- Fluent understanding in English, Hmong or Karenni
Exclusion Criteria:
- Prior hysterectomy
- Impaired decision-making capacity
- Pregnancy
Sites / Locations
- MCHH's Community Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05286749
First Posted
March 9, 2022
Last Updated
August 21, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
Milwaukee Consortium for Hmong Health (MCHH)
1. Study Identification
Unique Protocol Identification Number
NCT05286749
Brief Title
Cervical Cancer Self-Collection for Hmong and Karenni Women
Official Title
Community Health Outreach to Increase Cervical Cancer Education and Self-Collection Screening (CHOICESS) Program for Karenni and Hmong Women in Wisconsin
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 13, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Milwaukee Consortium for Hmong Health (MCHH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
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 Hmong and Karenni refugee and immigrant 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 Hmong and Karenni 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer Screening
Keywords
self-collection, community health workers
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Workshops are randomized to either a control or intervention group
Masking
Participant
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.
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Workshop plus Clinician-Collected Cervical Swab
Intervention Description
clinician-collection methods using speculum and cervical swabs
Intervention Type
Device
Intervention Name(s)
Workshop plus Participant-Collected Cervical Swab
Intervention Description
Evalyn® Brush (Rovers® Medical Devices, Netherlands)
Intervention Type
Diagnostic Test
Intervention Name(s)
HPV testing on Participant-Collected Cervical Swab Samples
Intervention Description
Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)
Primary Outcome Measure Information:
Title
Number of Participants Who Obtain or Self-Report Future Desire for Cervical Cancer Screening
Description
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
Secondary Outcome Measure Information:
Title
Participant Satisfaction With Educational Workshops Survey Scores
Description
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.
Time Frame
up to 1 day (pre workshop and post-workshop, up to 3 hours between surveys)
Title
Number of Participants willing to use HPV self-collect device for their cervical cancer screening
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fluent understanding in English, Hmong or Karenni
Exclusion Criteria:
Prior hysterectomy
Impaired decision-making capacity
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Dalby, MD
Organizational Affiliation
UW School of Medicine and Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
MCHH's Community Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cervical Cancer Self-Collection for Hmong and Karenni Women
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