Cervical Cancer Self-Collection for Southeast Asian Immigrant and Refugee Women
NCT ID: NCT05286749
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
153 participants
INTERVENTIONAL
2022-08-13
2024-02-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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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)
Interventions
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Workshop plus Clinician-Collected Cervical Swab
clinician-collection methods using speculum and cervical swabs
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)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Impaired decision-making capacity
* Pregnancy
25 Years
65 Years
FEMALE
Yes
Sponsors
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Milwaukee Consortium for Hmong Health (MCHH)
OTHER
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Jessica Dalby, MD
Role: PRINCIPAL_INVESTIGATOR
UW School of Medicine and Public Health
Locations
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MCHH's Community Center
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Protocol Version 8/8/2023
Identifier Type: OTHER
Identifier Source: secondary_id
UW21142
Identifier Type: OTHER
Identifier Source: secondary_id
A532050
Identifier Type: OTHER
Identifier Source: secondary_id
2021-1525
Identifier Type: -
Identifier Source: org_study_id
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