Clinical trial NCT05286749: Cervical Cancer Self-Collection for Southeast Asian Immigrant and Refugee Women
Official title: Community Health Outreach to Increase Cervical Cancer Education and Self-Collection Screening (CHOICESS) Program for Southeast Asian Immigrant and Refugee Women in Wisconsin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer Screening
Keywords: self-collection
community health workers
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Milwaukee Consortium for Hmong Health (MCHH)
First posted: 2022-03-18
Enrollment: 153
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Workshops are randomized to either a control or intervention group
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Prior hysterectomy
* Impaired decision-making capacity
* Pregnancy

Primary outcomes:
measure: Number of Participants Who Obtain or Self-Report Future Desire for Cervical Cancer Screening
timeFrame: up to 1 day
Secondary outcomes:
measure: Participant Satisfaction With Educational Workshops Survey Scores
timeFrame: up to 1 day (pre workshop and post-workshop, up to 3 hours between surveys)
measure: Number of Participants Willing to Use HPV Self-collect Device for Their Cervical Cancer Screening
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: MCHH's Community Center
state: Wisconsin
Study officials:
affiliation: UW School of Medicine and Public Health
name: Jessica Dalby, MD
role: PRINCIPAL_INVESTIGATOR
References: