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

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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer Screening
• Intervention / Treatment: Procedure: Workshop plus Clinician-Collected Cervical Swab; Device: Workshop plus Participant-Collected Cervical Swab; Diagnostic test: HPV testing on Participant-Collected Cervical Swab Samples

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.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53205
      • MCHH's Community Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Fluent understanding in English, Hmong, Karen, Burmese, or Karenni

Exclusion Criteria:

• Prior hysterectomy
• Impaired decision-making capacity
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Milwaukee Consortium for Hmong Health (MCHH)
• Investigators: Principal Investigator: Jessica Dalby, MD, UW School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2022
• Primary Completion (Actual): February 10, 2024
• Study Completion (Actual): February 10, 2024

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: community health workers; self-collection
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: 2021-1525; UW21142 (Other Identifier: UWCCC); A532050 (Other Identifier: UW Madison); Protocol Version 8/8/2023 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes