NCT05286749

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Cancer Screening

Interventions

Type	Name	Description
PROCEDURE	Workshop plus Clinician-Collected Cervical Swab	clinician-collection methods using speculum and cervical swabs
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)

Timeline

• Start date: 2022-08-13
• Primary completion: 2024-02-10
• Completion: 2024-02-10
• First posted: 2022-03-18
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study