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

University of Wisconsin (UW)

Status: Completed

Conditions: Cervical Cancer Screening

Treatments: Diagnostic Test: HPV testing on Participant-Collected Cervical Swab Samples; Device: Workshop plus Participant-Collected Cervical Swab; Procedure: Workshop plus Clinician-Collected Cervical Swab

Study type: Interventional

Funder types: Other

Identifiers

NCT05286749

UW21142 (Other Identifier)

2021-1525

A532050 (Other Identifier)

Protocol Version 8/8/2023 (Other Identifier)

Details and patient eligibility

About

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 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.

Enrollment: 153 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Prior hysterectomy
• Impaired decision-making capacity
• Pregnancy

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 2 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Procedure: Workshop plus Clinician-Collected Cervical Swab

Intervention

Experimental group

Description:

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.

Treatment:

Device: Workshop plus Participant-Collected Cervical Swab

Diagnostic Test: HPV testing on Participant-Collected Cervical Swab Samples