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

Not Applicable

Completed

• Conditions: Cervical Cancer Screening

• Registration Number: NCT05286749
• Lead Sponsor: University of Wisconsin, Madison

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 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

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 Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-18
• Study Start: 2022-08-13
• Status Verified: 2024-02
• Primary Completion: 2024-02-10
• Study Completion: 2024-02-10
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 149

Inclusion Criteria

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

Exclusion Criteria

• Prior hysterectomy
• Impaired decision-making capacity
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Obtain or Self-Report Future Desire for Cervical Cancer Screening	up to 1 day	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

Name	Time	Method
Participant Satisfaction With Educational Workshops Survey Scores	up to 1 day (pre workshop and post-workshop, up to 3 hours between surveys)	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.
Number of Participants Willing to Use HPV Self-collect Device for Their Cervical Cancer Screening	up to 1 day	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.

Trial Locations

Locations (1)

MCHH's Community Center; 🇺🇸 Milwaukee, Wisconsin, United States