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Completed

NCT Number: NCT05286749

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

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.

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Key information

Conditions

Cervical Cancer Screening

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MCHH's Community Center

Milwaukee, Wisconsin, 53205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Prior hysterectomy
  • Impaired decision-making capacity
  • Pregnancy

Treatment and study plan

Workshop plus Clinician-Collected Cervical Swab

Procedure

clinician-collection methods using speculum and cervical swabs

Workshop plus Participant-Collected Cervical Swab

Device

Evalyn® Brush (Rovers® Medical Devices, Netherlands)

HPV testing on Participant-Collected Cervical Swab Samples

Diagnostic Test

Roche Cobas4800 HPV Test System (Roche Molecular Systems Inc., Rotkreuz, Switzerland)

Primary outcomes

  1. 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 outcomes

  1. 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 1 to 5 where higher scores are a proxy for positive workshop impact on participant. Additional items will include open ended questions on satisfaction.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Milwaukee Consortium for Hmong Health (MCHH)

Registry information

Official study title

Community Health Outreach to Increase Cervical Cancer Education and Self-Collection Screening (CHOICESS) Program for Southeast Asian Immigrant and Refugee Women in Wisconsin

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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