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

Cervical Cancer Screening Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05286749
• Other study ID #: 2021-1525
• Secondary ID: Protocol Version
• Status: Completed
• Phase: N/A
• Start date: August 13, 2022
• Est. completion date: February 10, 2024

Study information

• Verified date: February 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: February 10, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Prior hysterectomy

• Impaired decision-making capacity

• Pregnancy

Related Conditions & MeSH terms

• Cervical Cancer Screening
• Uterine Cervical Neoplasms

Intervention

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)

Locations

Country	Name	City	State
United States	MCHH's Community Center	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Milwaukee Consortium for Hmong Health (MCHH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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