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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 10, 2024

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.

Interventions

  • 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)

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants Who Obtain or Self-Report Future Desire for Cervical Cancer Screening
    • Time Frame: 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 Measures

  • Participant Satisfaction With Educational Workshops Survey Scores
    • Time Frame: 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 5 to 20 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
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Fluent understanding in English, Hmong, Karen, Burmese, or Karenni Exclusion Criteria:

  • Prior hysterectomy – Impaired decision-making capacity – Pregnancy

Gender Eligibility: Female

Minimum Age: 25 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Wisconsin, Madison
  • Collaborator
    • Milwaukee Consortium for Hmong Health (MCHH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jessica Dalby, MD, Principal Investigator, UW School of Medicine and Public Health

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